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    Clinical Trial Results:
    Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis

    Summary
    EudraCT number
    		 2013-005551-32
    Trial protocol
    		 CZ   BE   DK   PL  
    Global end of trial date
    20 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Apr 2017
    First version publication date
    13 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20110174
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02186171
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the effect of treatment with romosozumab for 12 months compared with placebo on percent changes from baseline in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy x-ray absorptiometry (DXA) in men with osteoporosis.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) and applicable regulatory requirements. All subjects provided written informed consent before undergoing any study-related procedures, including screening procedures. The study protocol, amendments, and the informed consent form (ICF) were reviewed by the Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). No subjects were recruited into the study and no investigational product (IP) was shipped until the IRB/IEC gave written approval of the protocol and ICF and Amgen received copies of these approvals.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 47
    Country: Number of subjects enrolled
    Czech Republic: 27
    Country: Number of subjects enrolled
    Denmark: 35
    Country: Number of subjects enrolled
    Belgium: 18
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Switzerland: 15
    Country: Number of subjects enrolled
    Colombia: 35
    Country: Number of subjects enrolled
    Japan: 27
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    245
    EEA total number of subjects
    127
    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)
    42
    From 65 to 84 years
    197
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 31 centers in Europe, North America, Latin America, and Japan. Participants were enrolled from 16 June 2014 to 27 January 2015.

    Pre-assignment
    Screening details
    		 Participants were randomized in a 2:1 ratio to receive 210 mg romosozumab or matched placebo in a blinded fashion for the duration of the 12-month treatment period. Randomization was stratified by geographic region (Europe, North America, Latin America, and Japan).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo subcutaneous injections once a month (QM) for 12 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection once a month

    Arm title
    		 Romosozumab
    Arm description
    		 Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Romosozumab
    Investigational medicinal product code
    AMG 785
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection once a month

    Number of subjects in period 1
    		Placebo Romosozumab
    Started
    82
    163
    Received Treatment
    81
    163
    Completed
    78
    148
    Not completed
    4
    15
         Consent withdrawn by subject
    1
    9
         Death
    1
    2
         Lost to follow-up
    2
    2
         Protocol-specified criteria
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo subcutaneous injections once a month (QM) for 12 months.

    Reporting group title
    Romosozumab
    Reporting group description
    		 Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

    Reporting group values
    		 Placebo Romosozumab Total
    Number of subjects
    		 82 163 245
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 11 31 42
        From 65-74 years
    		 42 62 104
        75 years and over
    		 29 70 99
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.5 ± 6.9 72.4 ± 7.4 -
    Gender Categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 82 163 245
    Race
    Units: Subjects
        White
    		 60 120 180
        Asian
    		 9 18 27
        Black or African American
    		 0 1 1
        Other
    		 13 23 36
        Multiple
    		 0 1 1
    Geographic Region
    Units: Subjects
        Europe
    		 54 108 162
        Japan
    		 9 18 27
        Latin America
    		 12 23 35
        North America
    		 7 14 21
    Lumbar Spine BMD T-score
    The T-score is the bone mineral density (BMD) at the site when compared to that of a healthy thirty-year-old. Normal is a T-score of −1.0 or higher; Osteopenia is defined as between −1.0 and −2.5; Osteoporosis is defined as −2.5 or lower, meaning a bone density that is two and a half standard deviations below the mean of a thirty-year-old man/woman.
    Units: T-score
        arithmetic mean (standard deviation)
    		 -2.33 ± 1.41 -2.22 ± 1.19 -
    Total Hip BMD T-score
    Units: T-score
        arithmetic mean (standard deviation)
    		 -1.92 ± 0.65 -1.92 ± 0.59 -
    Femoral Neck BMD T-score
    Units: T-score
        arithmetic mean (standard deviation)
    		 -2.3 ± 0.52 -2.34 ± 0.52 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo subcutaneous injections once a month (QM) for 12 months.

    Reporting group title
    Romosozumab
    Reporting group description
    		 Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

    Primary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12

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    End point title
    		 Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12
    End point description
    Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. This endpoint was analyzed using the primary efficacy analysis subset which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the lumbar spine; last observation carried forward (LOCF) imputation was used.
    End point type
    Primary
    End point timeframe
    Baseline and month 12
    End point values
    		 Placebo Romosozumab
    Number of subjects analysed
    79
    157
    Units: percent change
        least squares mean (standard error)
    1.2 ± 0.5
    12.1 ± 0.5
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Placebo v Romosozumab
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    10.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.6
         upper limit
    		 12.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6
    Notes
    [1] - ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.

    Secondary: Percent Change from Baseline in BMD at the Total Hip at Month 12

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    End point title
    		 Percent Change from Baseline in BMD at the Total Hip at Month 12
    End point description
    Total hip bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. This endpoint was analyzed using the primary efficacy analysis subset which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the total hip; LOCF imputation was used.
    End point type
    Secondary
    End point timeframe
    Baseline and month 12
    End point values
    		 Placebo Romosozumab
    Number of subjects analysed
    79
    158
    Units: percent change
        least squares mean (standard error)
    -0.5 ± 0.3
    2.5 ± 0.2
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Placebo v Romosozumab
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.0001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.3
         upper limit
    		 3.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [2] - The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.
    [3] - ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.

    Secondary: Percent Change from Baseline in BMD at the Femoral Neck at Month 12

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    End point title
    		 Percent Change from Baseline in BMD at the Femoral Neck at Month 12
    End point description
    Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. This endpoint was analyzed using the primary efficacy analysis subset which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the femoral neck; LOCF imputation was used.
    End point type
    Secondary
    End point timeframe
    Baseline and month 12
    End point values
    		 Placebo Romosozumab
    Number of subjects analysed
    79
    158
    Units: percent change
        least squares mean (standard error)
    -0.2 ± 0.4
    2.2 ± 0.4
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Placebo v Romosozumab
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.0001 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment Difference
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 3.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5
    Notes
    [4] - The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.
    [5] - ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.

    Secondary: Percent Change From Baseline in Lumbar Spine BMD at Month 6

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    End point title
    		 Percent Change From Baseline in Lumbar Spine BMD at Month 6
    End point description
    Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. This endpoint was analyzed using the primary efficacy analysis subset with available data at baseline and month 6.
    End point type
    Secondary
    End point timeframe
    Baseline and month 6
    End point values
    		 Placebo Romosozumab
    Number of subjects analysed
    78
    156
    Units: percent change
        least squares mean (standard error)
    0.3 ± 0.4
    9 ± 0.4
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Placebo v Romosozumab
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 < 0.0001 [7]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.6
         upper limit
    		 9.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5
    Notes
    [6] - The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.
    [7] - ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.

    Secondary: Percent Change from Baseline in BMD at the Total Hip at Month 6

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    End point title
    		 Percent Change from Baseline in BMD at the Total Hip at Month 6
    End point description
    Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. This endpoint was analyzed using the primary efficacy analysis subset with available data at baseline and month 6.
    End point type
    Secondary
    End point timeframe
    Baseline and month 6
    End point values
    		 Placebo Romosozumab
    Number of subjects analysed
    78
    157
    Units: percent change
        least squares mean (standard error)
    0.2 ± 0.2
    1.6 ± 0.2
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Placebo v Romosozumab
    Number of subjects included in analysis
    235
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 < 0.0001 [9]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Treatment Difference
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [8] - The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.
    [9] - ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.

    Secondary: Percent Change from Baseline in BMD at the Femoral Neck at Month 6

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    End point title
    		 Percent Change from Baseline in BMD at the Femoral Neck at Month 6
    End point description
    Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. This endpoint was analyzed using the primary efficacy analysis subset with available data at baseline and month 6.
    End point type
    Secondary
    End point timeframe
    Baseline and month 6
    End point values
    		 Placebo Romosozumab
    Number of subjects analysed
    78
    157
    Units: percent change
        least squares mean (standard error)
    0 ± 0.4
    1.2 ± 0.3
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Placebo v Romosozumab
    Number of subjects included in analysis
    235
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 = 0.0033 [11]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 2.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [10] - The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.
    [11] - ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    15 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Romosozumab
    Reporting group description
    		 Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo subcutaneous injections once a month (QM) for 12 months.

    Serious adverse events
    		 Romosozumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 163 (14.11%)
    10 / 81 (12.35%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve disease
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wolff-Parkinson-White syndrome
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid arteriosclerosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Implant site haematoma
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Romosozumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    122 / 163 (74.85%)
    65 / 81 (80.25%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Benign lung neoplasm
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Benign neoplasm of adrenal gland
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Benign renal neoplasm
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Lipoma
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Paranasal sinus benign neoplasm
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Prostatic adenoma
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Skin papilloma
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    3
    0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Aortic dilatation
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    2
    Arteriosclerosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Essential hypertension
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Haematoma
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 81 (0.00%)
         occurrences all number
    3
    0
    Hypertension
         subjects affected / exposed
    14 / 163 (8.59%)
    5 / 81 (6.17%)
         occurrences all number
    17
    5
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Peripheral venous disease
         subjects affected / exposed
    4 / 163 (2.45%)
    0 / 81 (0.00%)
         occurrences all number
    4
    0
    Subclavian artery stenosis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Varicose vein
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    Osteosynthesis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site dermatitis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Chills
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Discomfort
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Drug withdrawal syndrome
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    3 / 163 (1.84%)
    4 / 81 (4.94%)
         occurrences all number
    3
    4
    Influenza like illness
         subjects affected / exposed
    6 / 163 (3.68%)
    0 / 81 (0.00%)
         occurrences all number
    6
    0
    Injection site bruising
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Injection site erythema
         subjects affected / exposed
    3 / 163 (1.84%)
    1 / 81 (1.23%)
         occurrences all number
    5
    1
    Injection site haematoma
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Injection site hypersensitivity
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Injection site induration
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Injection site pain
         subjects affected / exposed
    4 / 163 (2.45%)
    0 / 81 (0.00%)
         occurrences all number
    9
    0
    Injection site pruritus
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 81 (2.47%)
         occurrences all number
    3
    2
    Injection site swelling
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Local swelling
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    House dust allergy
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 81 (2.47%)
         occurrences all number
    1
    2
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Benign prostatic hyperplasia
         subjects affected / exposed
    5 / 163 (3.07%)
    0 / 81 (0.00%)
         occurrences all number
    5
    0
    Breast pain
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Breast swelling
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Nipple disorder
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Prostatitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Allergic pharyngitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Asthma
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Bronchiectasis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    5 / 163 (3.07%)
    1 / 81 (1.23%)
         occurrences all number
    5
    1
    Dyspnoea
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Emphysema
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    Productive cough
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Affective disorder
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Confusional state
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Depressed mood
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Insomnia
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Personality change due to a general medical condition
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Restlessness
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Blood glucose increased
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Blood uric acid increased
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Heart rate irregular
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Vitamin D decreased
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Vitamin D increased
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Arthropod sting
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Chest injury
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    0 / 163 (0.00%)
    3 / 81 (3.70%)
         occurrences all number
    0
    3
    Face injury
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    6 / 163 (3.68%)
    2 / 81 (2.47%)
         occurrences all number
    7
    4
    Head injury
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Joint injury
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Laceration
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Meniscus injury
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Post procedural haematoma
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Procedural pain
         subjects affected / exposed
    8 / 163 (4.91%)
    6 / 81 (7.41%)
         occurrences all number
    9
    7
    Skin abrasion
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Tendon rupture
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    3
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Aortic valve incompetence
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Atrial fibrillation
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Atrial flutter
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Extrasystoles
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Left atrial dilatation
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Cerebral arteriosclerosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Cognitive disorder
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Disturbance in attention
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    5 / 163 (3.07%)
    1 / 81 (1.23%)
         occurrences all number
    5
    1
    Dysaesthesia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    10 / 163 (6.13%)
    6 / 81 (7.41%)
         occurrences all number
    12
    7
    Hypoaesthesia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    IIIrd nerve paralysis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    IVth nerve paralysis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Loss of consciousness
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Polyneuropathy
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Radicular syndrome
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Radiculopathy
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Seizure
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    VIth nerve paralysis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 81 (2.47%)
         occurrences all number
    1
    2
    Lymphadenopathy
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Vertigo positional
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Arteriosclerotic retinopathy
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Blepharitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Cataract
         subjects affected / exposed
    4 / 163 (2.45%)
    1 / 81 (1.23%)
         occurrences all number
    4
    1
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Ectropion
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Eye allergy
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Eye pain
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Glaucoma
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Macular degeneration
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Abdominal hernia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 81 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain upper
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 81 (0.00%)
         occurrences all number
    5
    0
    Ascites
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Cheilitis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Cheilosis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Coeliac artery stenosis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    9 / 163 (5.52%)
    1 / 81 (1.23%)
         occurrences all number
    10
    1
    Dental caries
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 81 (0.00%)
         occurrences all number
    3
    0
    Diarrhoea
         subjects affected / exposed
    6 / 163 (3.68%)
    4 / 81 (4.94%)
         occurrences all number
    6
    4
    Diverticulum
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Diverticulum intestinal
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    3 / 163 (1.84%)
    3 / 81 (3.70%)
         occurrences all number
    4
    4
    Eructation
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Functional gastrointestinal disorder
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Gastric ulcer
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Inguinal hernia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Intestinal dilatation
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Large intestine polyp
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Loose tooth
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Mesenteric artery stenosis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Odynophagia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Oesophagitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Pancreatic cyst
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Periodontal disease
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Teeth brittle
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Truncus coeliacus thrombosis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Gallbladder polyp
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Hepatic cyst
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Hepatomegaly
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Blister
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Ecchymosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Miliaria
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Papule
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    Pruritus generalised
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Psoriasis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Rosacea
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Skin mass
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Vitiligo
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Nephropathy
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Renal artery stenosis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    2
    Renal cyst
         subjects affected / exposed
    3 / 163 (1.84%)
    1 / 81 (1.23%)
         occurrences all number
    3
    1
    Renal injury
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Urinary bladder polyp
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Urinary retention
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 163 (6.13%)
    8 / 81 (9.88%)
         occurrences all number
    13
    9
    Arthritis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    15 / 163 (9.20%)
    4 / 81 (4.94%)
         occurrences all number
    15
    4
    Bone pain
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Bursa disorder
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Intervertebral disc degeneration
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Limb discomfort
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    3 / 163 (1.84%)
    5 / 81 (6.17%)
         occurrences all number
    3
    7
    Muscular weakness
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    5 / 163 (3.07%)
    0 / 81 (0.00%)
         occurrences all number
    7
    0
    Myalgia
         subjects affected / exposed
    4 / 163 (2.45%)
    5 / 81 (6.17%)
         occurrences all number
    6
    5
    Osteitis deformans
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Osteoarthritis
         subjects affected / exposed
    8 / 163 (4.91%)
    2 / 81 (2.47%)
         occurrences all number
    8
    2
    Pain in extremity
         subjects affected / exposed
    6 / 163 (3.68%)
    2 / 81 (2.47%)
         occurrences all number
    7
    2
    Periarthritis
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    3
    0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Rib deformity
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 81 (2.47%)
         occurrences all number
    2
    2
    Spinal pain
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    Trigger finger
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    3 / 163 (1.84%)
    3 / 81 (3.70%)
         occurrences all number
    3
    3
    Bronchitis viral
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Fungal infection
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Furuncle
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 163 (1.84%)
    2 / 81 (2.47%)
         occurrences all number
    4
    4
    Gastroenteritis viral
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Influenza
         subjects affected / exposed
    4 / 163 (2.45%)
    0 / 81 (0.00%)
         occurrences all number
    4
    0
    Laryngitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Localised infection
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    35 / 163 (21.47%)
    22 / 81 (27.16%)
         occurrences all number
    45
    23
    Onychomycosis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Oral fungal infection
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Otitis externa bacterial
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Paronychia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Periodontitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    4 / 163 (2.45%)
    1 / 81 (1.23%)
         occurrences all number
    4
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Pulpitis dental
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    4 / 163 (2.45%)
    0 / 81 (0.00%)
         occurrences all number
    4
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 81 (2.47%)
         occurrences all number
    1
    2
    Sinusitis
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    3
    0
    Tonsillitis
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Tooth abscess
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Tooth infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 163 (3.07%)
    4 / 81 (4.94%)
         occurrences all number
    5
    4
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    1 / 163 (0.61%)
    3 / 81 (3.70%)
         occurrences all number
    2
    4
    Urinary tract infection
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 81 (2.47%)
         occurrences all number
    1
    2
    Viral infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Viral rhinitis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Wound infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Wound infection staphylococcal
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Dyslipidaemia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Gout
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    2
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Hypermagnesaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jul 2014
    - Inclusion criteria: Number 103: added assessment by the central imaging vendor at screening for BMD T-scores - Exclusion criteria and Excluded treatments: deleted tibolone. - Study procedures: Clarified intervals for DXA scans taken for the screening period; defined day 1 and subsequent visit dates.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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