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    Clinical Trial Results:
    A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab via Prefilled Syringe

    Summary
    EudraCT number
    		 2017-003512-40
    Trial protocol
    		 GB   PL  
    Global end of trial date
    08 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Nov 2020
    First version publication date
    21 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20150120
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03432533
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States,
    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
    08 Jan 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the noninferiority of a 6-month treatment with romosozumab 210 mg administered subcutaneously (SC) once monthly (QM) in postmenopausal women with osteoporosis either by subject self-administration with autoinjector (AI)/pen or by healthcare provider (HCP) administration with prefilled syringe (PFS).
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and local regulations/guidelines. The investigator or his/her designee informed the subject of all aspects pertaining to the subject’s participation in the study before any screening procedures were performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Feb 2018
    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
    United States: 95
    Country: Number of subjects enrolled
    United Kingdom: 32
    Country: Number of subjects enrolled
    Poland: 156
    Worldwide total number of subjects
    283
    EEA total number of subjects
    188
    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)
    74
    From 65 to 84 years
    197
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 36 centers in Poland, United Kingdom, and United States.

    Pre-assignment
    Screening details
    		 Participants were randomized in a 1:1 ratio.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Romosozumab 210 mg QM: PFS
    Arm description
    		 During the open-label treatment period, participants received 210 mg romosozumab subcutaneously (SC) once a month (QM) by health care provider (HCP) administration with pre-filled syringe (PFS).
    Arm type
    		 Experimental

    Investigational medicinal product name
    romosozumab
    Investigational medicinal product code
    AMG785
    Other name
    Evenity
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subconjunctival use, Subcutaneous use
    Dosage and administration details
    210 mg romosozumab SC QM by HCP administration with 2 PFS

    Arm title
    		 Romosozumab 210 mg QM: AI/Pen
    Arm description
    		 During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with autoinjector (AI)/pen.
    Arm type
    		 Experimental

    Investigational medicinal product name
    romosozumab
    Investigational medicinal product code
    AMG785
    Other name
    Evenity
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    210 mg romosozumab SC QM by self-administration with 2 AI/Pens

    Number of subjects in period 1
    		Romosozumab 210 mg QM: PFS Romosozumab 210 mg QM: AI/Pen
    Started
    141
    142
    Completed 6-Month Treatment Period
    136
    137
    Completed
    126
    131
    Not completed
    15
    11
         Consent withdrawn by subject
    14
    9
         Lost to follow-up
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Romosozumab 210 mg QM: PFS
    Reporting group description
    		 During the open-label treatment period, participants received 210 mg romosozumab subcutaneously (SC) once a month (QM) by health care provider (HCP) administration with pre-filled syringe (PFS).

    Reporting group title
    Romosozumab 210 mg QM: AI/Pen
    Reporting group description
    		 During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with autoinjector (AI)/pen.

    Reporting group values
    		 Romosozumab 210 mg QM: PFS Romosozumab 210 mg QM: AI/Pen Total
    Number of subjects
    		 141 142 283
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 70.3 ( 7.1 ) 69.5 ( 8.4 ) -
    Sex: Female, Male
    Units:
        Female
    		 141 142 283
        Male
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 3 1 4
        Not Hispanic or Latino
    		 138 141 279
        Unknown or Not Reported
    		 0 0 0
    Participants With Pre-Existing Anti-Romosozumab Antibodies
    Number of participants with pre-existing antibodies, including those who were binding antibody positive and those who were neutralizing antibody positive at or before baseline (BL).
    Units: Subjects
        Binding Antibody Positive at or Before BL
    		 3 0 3
        Neutralizing Antibody Positive at or Before BL
    		 0 0 0
        Binding Antibody Negative at or Before BL
    		 138 142 280
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 1 1 2
        White
    		 139 140 279
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Lumbar Spine Bone Mineral Density (BMD) T-Score
    The T-score is the BMD at the site when compared to that of a healthy thirty-year-old of the same sex. Lower scores (more negative) mean lower bone density. Normal is a T-score of −1.0 or higher; Osteopenia is defined as between −1.0 and −2.5, meaning below-normal bone density without full osteoporosis; 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)
    		 -2.69 ( 1.03 ) -2.85 ( 1.00 ) -
    Total Hip BMD T-Score
    The T-score is the BMD at the site when compared to that of a healthy thirty-year-old of the same sex. Lower scores (more negative) mean lower bone density. Normal is a T-score of −1.0 or higher; Osteopenia is defined as between −1.0 and −2.5, meaning below-normal bone density without full osteoporosis; 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)
    		 -2.29 ( 0.73 ) -2.30 ( 0.77 ) -
    Femoral Neck BMD T-Score
    The T-score is the BMD at the site when compared to that of a healthy thirty-year-old of the same sex. Lower scores (more negative) mean lower bone density. Normal is a T-score of −1.0 or higher; Osteopenia is defined as between −1.0 and −2.5, meaning below-normal bone density without full osteoporosis; 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)
    		 -2.54 ( 0.63 ) -2.49 ( 0.65 ) -

    End points

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    End points reporting groups
    Reporting group title
    Romosozumab 210 mg QM: PFS
    Reporting group description
    		 During the open-label treatment period, participants received 210 mg romosozumab subcutaneously (SC) once a month (QM) by health care provider (HCP) administration with pre-filled syringe (PFS).

    Reporting group title
    Romosozumab 210 mg QM: AI/Pen
    Reporting group description
    		 During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with autoinjector (AI)/pen.

    Primary: 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
    Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    End point values
    		 Romosozumab 210 mg QM: PFS Romosozumab 210 mg QM: AI/Pen
    Number of subjects analysed
    135
    134
    Units: percent change
        least squares mean (standard error)
    9.2 ( 0.4 )
    9.0 ( 0.5 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Romosozumab 210 mg QM: PFS v Romosozumab 210 mg QM: AI/Pen
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.84
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6
    Notes
    [1] - Conclusions for the primary efficacy hypothesis of efficacy of self-administration of romosozumab by AI/Pen compared with HCP-administered romosozumab by PFS at lumbar spine BMD at Month 6 was made using a 1-sided test with type 1 error rate of 0.025 and noninferiority margin of -2.0%.

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

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    End point title
    		 Percent Change From Baseline in Total Hip BMD at Month 6
    End point description
    Percent change from baseline in BMD for total hip as measured by DXA.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 Romosozumab 210 mg QM: PFS Romosozumab 210 mg QM: AI/Pen
    Number of subjects analysed
    135
    134
    Units: percent change
        least squares mean (standard error)
    3.7 ( 0.6 )
    3.6 ( 0.3 )
    No statistical analyses for this end point

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

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    End point title
    		 Percent Change From Baseline in Femoral Neck BMD at Month 6
    End point description
    Percent change from baseline in BMD at femoral neck as measured by DXA.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    		 Romosozumab 210 mg QM: PFS Romosozumab 210 mg QM: AI/Pen
    Number of subjects analysed
    135
    134
    Units: percent change
        least squares mean (standard error)
    3.4 ( 0.7 )
    3.6 ( 0.5 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
    End point description
    AE: any untoward medical occurrence irrespective of a causal relationship with the study treatment. SAE: any untoward medical occurrence that meets at least 1 of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important serious event. Adverse device effect: any AE related to the use of a combination product or medical device. TEAEs are those AEs occurring after first dose of study drug.
    End point type
    Secondary
    End point timeframe
    up to Month 9 (-7/+3 days)
    End point values
    		 Romosozumab 210 mg QM: PFS Romosozumab 210 mg QM: AI/Pen
    Number of subjects analysed
    141
    142
    Units: participants
        TEAEs: All
    94
    96
        TEAEs: SAEs
    7
    4
        TEAEs: Leading to Study Drug Discontinuation (DC)
    7
    15
        TEAEs: Fatal
    0
    0
        Treatment-Related (TR) TEAEs: All
    38
    59
        TR TEAEs: SAEs
    0
    0
        TR TEAEs: Leading to Study Drug DC
    6
    10
        TR TEAEs: Fatal
    0
    0
        Device-Related (DR) TEAEs: All
    18
    30
        DR TEAEs: SAEs
    0
    0
        DR TEAEs: Leading to Study Drug DC
    0
    5
        DR TEAEs: Fatal
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants Developing Anti-Romosozumab Antibodies

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    End point title
    		 Number of Participants Developing Anti-Romosozumab Antibodies
    End point description
    Participants with a negative or no result at baseline (BL) developing anti-romosozumab antibodies postbaseline, including those who were binding antibody-positive or neutralizing antibody-positive postbaseline. 'Transient' positive results are those with a negative result at the participant's last time point tested within the study period.
    End point type
    Secondary
    End point timeframe
    up to Month 9 (-7/+3 days)
    End point values
    		 Romosozumab 210 mg QM: PFS Romosozumab 210 mg QM: AI/Pen
    Number of subjects analysed
    139
    142
    Units: participants
        Binding Antibody Positive Post-BL
    21
    22
        Transient Binding Antibody Positive Post-BL
    6
    3
        Neutralizing Antibody Positive Post-BL
    5
    4
        Transient Neutralizing Antibody Positive Post-BL
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to Month 9 (-7/+3 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Romosozumab 210 mg SC QM by PFS
    Reporting group description
    		 During the open-label treatment period, participants received 210 mg romosozumab subcutaneously (SC) once a month (QM) by health care provider (HCP) administration with pre-filled syringe (PFS).

    Reporting group title
    Romosozumab 210 mg SC QM by AI/Pen
    Reporting group description
    		 During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with autoinjector (AI)/pen.

    Serious adverse events
    		 Romosozumab 210 mg SC QM by PFS Romosozumab 210 mg SC QM by AI/Pen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 141 (4.96%)
    4 / 142 (2.82%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (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
    Forearm fracture
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ischaemic
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (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
    Cellulitis
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (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 210 mg SC QM by PFS Romosozumab 210 mg SC QM by AI/Pen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    92 / 141 (65.25%)
    95 / 142 (66.90%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Meningioma
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Hot flush
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences all number
    2
    1
    Hypertension
         subjects affected / exposed
    3 / 141 (2.13%)
    1 / 142 (0.70%)
         occurrences all number
    3
    1
    Hypotension
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Vasculitis
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    25 / 141 (17.73%)
    35 / 142 (24.65%)
         occurrences all number
    49
    69
    Injection site pain
         subjects affected / exposed
    14 / 141 (9.93%)
    21 / 142 (14.79%)
         occurrences all number
    20
    34
    Injection site swelling
         subjects affected / exposed
    11 / 141 (7.80%)
    23 / 142 (16.20%)
         occurrences all number
    13
    43
    Asthenia
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Chills
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Cyst
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 142 (1.41%)
         occurrences all number
    1
    4
    Influenza like illness
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Injection site bruising
         subjects affected / exposed
    1 / 141 (0.71%)
    5 / 142 (3.52%)
         occurrences all number
    2
    7
    Injection site discolouration
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Injection site extravasation
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Injection site haemorrhage
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Injection site hypertrophy
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Injection site induration
         subjects affected / exposed
    2 / 141 (1.42%)
    2 / 142 (1.41%)
         occurrences all number
    7
    2
    Injection site irritation
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Injection site nodule
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Injection site oedema
         subjects affected / exposed
    2 / 141 (1.42%)
    4 / 142 (2.82%)
         occurrences all number
    2
    7
    Injection site pruritus
         subjects affected / exposed
    6 / 141 (4.26%)
    7 / 142 (4.93%)
         occurrences all number
    8
    15
    Injection site rash
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    0
    2
    Injection site reaction
         subjects affected / exposed
    3 / 141 (2.13%)
    2 / 142 (1.41%)
         occurrences all number
    4
    3
    Injection site urticaria
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    0
    2
    Injection site warmth
         subjects affected / exposed
    2 / 141 (1.42%)
    3 / 142 (2.11%)
         occurrences all number
    2
    6
    Malaise
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Mass
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    2
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    2
    Peripheral swelling
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Breast cyst
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 142 (2.11%)
         occurrences all number
    0
    3
    Dysphonia
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    2
    Dyspnoea
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    3 / 141 (2.13%)
    0 / 142 (0.00%)
         occurrences all number
    3
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Insomnia
         subjects affected / exposed
    3 / 141 (2.13%)
    2 / 142 (1.41%)
         occurrences all number
    3
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 141 (1.42%)
    0 / 142 (0.00%)
         occurrences all number
    2
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Blood urea increased
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Chest X-ray abnormal
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Arthropod bite
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Bone contusion
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Cataract operation complication
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    3 / 141 (2.13%)
    1 / 142 (0.70%)
         occurrences all number
    4
    1
    Epicondylitis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Facial bones fracture
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Fall
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Femur fracture
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Fibula fracture
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Foot fracture
         subjects affected / exposed
    2 / 141 (1.42%)
    2 / 142 (1.41%)
         occurrences all number
    2
    2
    Hand fracture
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Humerus fracture
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Post procedural complication
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Post-traumatic pain
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Radius fracture
         subjects affected / exposed
    2 / 141 (1.42%)
    0 / 142 (0.00%)
         occurrences all number
    2
    0
    Spinal column injury
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Tooth injury
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Cardiac disorders
    Bundle branch block right
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Myocardial ischaemia
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    2 / 141 (1.42%)
    0 / 142 (0.00%)
         occurrences all number
    2
    0
    Ventricular pre-excitation
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 141 (2.13%)
    9 / 142 (6.34%)
         occurrences all number
    4
    13
    Dementia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences all number
    2
    1
    Paraesthesia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Transient ischaemic attack
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    4 / 141 (2.84%)
    0 / 142 (0.00%)
         occurrences all number
    4
    0
    Neutropenia
         subjects affected / exposed
    2 / 141 (1.42%)
    2 / 142 (1.41%)
         occurrences all number
    2
    2
    Normocytic anaemia
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Ear congestion
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Tinnitus
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Blepharitis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Cataract
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Dry eye
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Entropion
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Macular degeneration
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Swelling of eyelid
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Visual impairment
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 142 (1.41%)
         occurrences all number
    1
    2
    Abdominal pain lower
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 142 (2.11%)
         occurrences all number
    0
    3
    Colitis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 142 (1.41%)
         occurrences all number
    1
    2
    Dental cyst
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Diaphragmatic hernia
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    5 / 141 (3.55%)
    1 / 142 (0.70%)
         occurrences all number
    5
    1
    Diverticulum intestinal
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    0
    2
    Dry mouth
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 142 (1.41%)
         occurrences all number
    1
    2
    Gingival pain
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Hiatus hernia
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Large intestine polyp
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 141 (1.42%)
    2 / 142 (1.41%)
         occurrences all number
    2
    2
    Oesophageal ulcer
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Oral mucosal blistering
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    2
    Stomatitis
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    0
    2
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Dermal cyst
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    3
    Pruritus generalised
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    4 / 141 (2.84%)
    1 / 142 (0.70%)
         occurrences all number
    4
    1
    Rash pruritic
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Swelling face
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Renal cyst
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Renal failure
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Urinary incontinence
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 141 (1.42%)
    0 / 142 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 141 (4.96%)
    9 / 142 (6.34%)
         occurrences all number
    8
    12
    Arthritis
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    2 / 141 (1.42%)
    3 / 142 (2.11%)
         occurrences all number
    2
    4
    Bone pain
         subjects affected / exposed
    3 / 141 (2.13%)
    1 / 142 (0.70%)
         occurrences all number
    3
    1
    Bursitis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 142 (1.41%)
         occurrences all number
    1
    2
    Muscular weakness
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences all number
    2
    1
    Neck pain
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Nodal osteoarthritis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    4 / 141 (2.84%)
    3 / 142 (2.11%)
         occurrences all number
    4
    5
    Plantar fasciitis
         subjects affected / exposed
    2 / 141 (1.42%)
    0 / 142 (0.00%)
         occurrences all number
    2
    0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences all number
    2
    1
    Spinal pain
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Spondylitis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    15 / 141 (10.64%)
    10 / 142 (7.04%)
         occurrences all number
    16
    10
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 141 (1.42%)
    8 / 142 (5.63%)
         occurrences all number
    2
    8
    Bacterial vulvovaginitis
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    4 / 141 (2.84%)
    6 / 142 (4.23%)
         occurrences all number
    4
    8
    Cystitis
         subjects affected / exposed
    3 / 141 (2.13%)
    0 / 142 (0.00%)
         occurrences all number
    3
    0
    Ear infection
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Furuncle
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Genital herpes
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Herpes virus infection
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    0
    2
    Herpes zoster
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Hordeolum
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Influenza
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Lung abscess
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences all number
    2
    1
    Pharyngitis
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    2 / 141 (1.42%)
    2 / 142 (1.41%)
         occurrences all number
    2
    2
    Rhinitis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences all number
    2
    1
    Tonsillitis
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Tooth infection
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Urethritis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    4 / 141 (2.84%)
    4 / 142 (2.82%)
         occurrences all number
    4
    4
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Viral labyrinthitis
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 142 (1.41%)
         occurrences all number
    1
    2
    Hyponatraemia
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Malnutrition
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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