Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in subjects with type 2 diabetes

    Summary
    EudraCT number
    		 2020-000299-39
    Trial protocol
    		 CZ   DE   SK   HU   BG   SI   PL   HR   EE  
    Global end of trial date
    06 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Mar 2024
    First version publication date
    23 Mar 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NN9924-4635
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04707469
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Alle, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    21 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm superiority of oral semaglutide 25 mg and 50 mg once daily versus oral semaglutide 14 mg once daily on glycated haemoglobin (HbA1c) reduction in subjects with type 2 diabetes (T2D) on stable dose of 1-3 oral anti-diabetic drugs (OADs).
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (64th World Medical Association [WMA] general assembly, Oct 2013) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice, including archiving of essential documents (Current step 4 version, Nov 2016), and 21 US Code of Federal Regulations (CFR) 312.120.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    15 Jan 2021
    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
    Australia: 37
    Country: Number of subjects enrolled
    Bulgaria: 153
    Country: Number of subjects enrolled
    Canada: 87
    Country: Number of subjects enrolled
    Croatia: 52
    Country: Number of subjects enrolled
    Czechia: 42
    Country: Number of subjects enrolled
    Estonia: 27
    Country: Number of subjects enrolled
    Germany: 89
    Country: Number of subjects enrolled
    Hungary: 97
    Country: Number of subjects enrolled
    India: 214
    Country: Number of subjects enrolled
    Poland: 289
    Country: Number of subjects enrolled
    Slovakia: 114
    Country: Number of subjects enrolled
    Slovenia: 48
    Country: Number of subjects enrolled
    Taiwan: 26
    Country: Number of subjects enrolled
    United States: 331
    Worldwide total number of subjects
    1606
    EEA total number of subjects
    911
    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)
    1110
    From 65 to 84 years
    494
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The trial was conducted in 14 countries (184 sites screened/177 randomised subjects) as follows: Australia: 7/6; Bulgaria: 15/15; Canada: 13/13; Croatia: 5/5; Czech Republic: 5/5; Estonia: 6/5; Germany: 8/8; Hungary: 9/9; India: 20/20; Poland: 18/18; Slovakia: 9/9; Slovenia: 5/5; Taiwan: 2/2; United States: 62/57.

    Pre-assignment
    Screening details
    		 Subjects were randomised in 1:1:1 ratio to receive either 14 mg, 25 mg or 50 mg oral semaglutide once daily. The trial had a 68-week treatment period (8-16 weeks of dose escalation period and 52-60 weeks of maintenance period), followed by a 5-week follow-up period.

    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
    		 Oral semaglutide 14 mg
    Arm description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 14 mg semaglutide tablet orally once daily in a dose escalation manner for 68 weeks.

    Arm title
    		 Oral semaglutide 25 mg
    Arm description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 25 mg semaglutide tablet orally once daily in a dose escalation manner for 68 weeks.

    Arm title
    		 Oral semaglutide 50 mg
    Arm description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 50 mg semaglutide tablet orally once daily in a dose escalation manner for 68 weeks.

    Number of subjects in period 1
    		Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Started
    536
    535
    535
    Treated
    534
    534
    534
    Full analysis set (FAS)
    536
    535
    535
    Safety analysis set (SAS)
    534
    534
    534
    Completed
    507
    490
    505
    Not completed
    29
    45
    30
         Adverse event, serious fatal
    1
    6
    2
         Physician decision
    2
    2
    2
         Consent withdrawn by subject
    17
    16
    12
         Lost to follow-up
    9
    19
    14
         Site closure
    -
    2
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Oral semaglutide 14 mg
    Reporting group description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.

    Reporting group title
    Oral semaglutide 25 mg
    Reporting group description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.

    Reporting group title
    Oral semaglutide 50 mg
    Reporting group description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.

    Reporting group values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg Total
    Number of subjects
    		 536 535 535 1606
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.4 ( 10.4 ) 58.8 ( 10.7 ) 57.6 ( 11.2 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 211 231 228 670
        Male
    		 325 304 307 936

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Oral semaglutide 14 mg
    Reporting group description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.

    Reporting group title
    Oral semaglutide 25 mg
    Reporting group description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.

    Reporting group title
    Oral semaglutide 50 mg
    Reporting group description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.

    Primary: Change in glycated haemoglobin (HbA1c)

    		 Close Top of page
    End point title
    		 Change in glycated haemoglobin (HbA1c)
    End point description
    Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a subject was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages. Full Analysis Set (FAS) which comprised all randomised subjects. Overall number of subjects analyzed = subjects with available data for this endpoint.
    End point type
    Primary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Number of subjects analysed
    497
    475
    492
    Units: Percentage point of HbA1c
        arithmetic mean (standard deviation)
    -1.5 ( 1.3 )
    -1.9 ( 1.3 )
    -2.1 ( 1.4 )
    Statistical analysis title
    		 Oral semaglutide 14 mg vs Oral semaglutide 25 mg
    Statistical analysis description
    Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.
    Comparison groups
    Oral semaglutide 14 mg v Oral semaglutide 25 mg
    Number of subjects included in analysis
    972
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 -0.12
    Notes
    [1] - Unadjusted two-sided p-value for test of no difference.
    Statistical analysis title
    		 Oral semaglutide 14 mg vs Oral semaglutide 50 mg
    Statistical analysis description
    Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.
    Comparison groups
    Oral semaglutide 14 mg v Oral semaglutide 50 mg
    Number of subjects included in analysis
    989
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference
    Point estimate
    -0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.68
         upper limit
    		 -0.38
    Notes
    [2] - Unadjusted two-sided p-value for test of no difference.

    Secondary: Change in body weight

    		 Close Top of page
    End point title
    		 Change in body weight
    End point description
    Change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a subject was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. FAS which comprised all randomised subjects. Overall number of subjects analyzed = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Number of subjects analysed
    503
    480
    495
    Units: Kilogram (Kg)
        arithmetic mean (standard deviation)
    -4.4 ( 5.2 )
    -7.1 ( 6.8 )
    -8.3 ( 7.5 )
    No statistical analyses for this end point

    Secondary: Change in fasting plasma glucose (FPG)

    		 Close Top of page
    End point title
    		 Change in fasting plasma glucose (FPG)
    End point description
    Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a subject was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. FAS which comprised all randomised subjects. Overall number of subjects analyzed = subjects with available data for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Number of subjects analysed
    494
    460
    482
    Units: millimole per litre (mmol/L)
        arithmetic mean (standard deviation)
    -2.4 ( 3.4 )
    -3.0 ( 3.5 )
    -3.2 ( 3.4 )
    No statistical analyses for this end point

    Secondary: Achievement of HbA1c below 7%

    		 Close Top of page
    End point title
    		 Achievement of HbA1c below 7%
    End point description
    Percentage of subjects who achieved HbA1c <7.0 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a subject was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
    End point type
    Secondary
    End point timeframe
    At week 52
    End point values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Number of subjects analysed
    536
    535
    535
    Units: Percentage of subjects
        number (not applicable)
    39
    50.5
    63
    No statistical analyses for this end point

    Secondary: Achievement of HbA1c equal to or below 6.5%

    		 Close Top of page
    End point title
    		 Achievement of HbA1c equal to or below 6.5%
    End point description
    Percentage of subjects who achieved HbA1c <=6.5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a subject was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
    End point type
    Secondary
    End point timeframe
    At week 52
    End point values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Number of subjects analysed
    536
    535
    535
    Units: Percentage of subjects
        number (not applicable)
    25.8
    39.6
    51.2
    No statistical analyses for this end point

    Secondary: Relative change in body weight

    		 Close Top of page
    End point title
    		 Relative change in body weight
    End point description
    Relative change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a subject was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. FAS which comprised all randomised subjects. Overall number of subjects analyzed = subjects with available data for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Number of subjects analysed
    503
    480
    495
    Units: Percentage change in body weight
        arithmetic mean (standard deviation)
    -4.7 ( 5.4 )
    -7.3 ( 6.6 )
    -8.5 ( 7.3 )
    No statistical analyses for this end point

    Secondary: Change in waist circumference

    		 Close Top of page
    End point title
    		 Change in waist circumference
    End point description
    Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a subject was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. FAS which comprised all randomised subjects. Overall number of subjects analyzed = subjects with available data for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to week 52
    End point values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Number of subjects analysed
    502
    479
    494
    Units: centimetre (cm)
        arithmetic mean (standard deviation)
    -4 ( 7 )
    -5 ( 7 )
    -6 ( 7 )
    No statistical analyses for this end point

    Secondary: Achievement of weight loss equal to or above 5%

    		 Close Top of page
    End point title
    		 Achievement of weight loss equal to or above 5%
    End point description
    Percentage of subjects who achieved weight loss >= 5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a subject was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
    End point type
    Secondary
    End point timeframe
    At week 52
    End point values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Number of subjects analysed
    536
    535
    535
    Units: Percentage of subjects
        number (not applicable)
    41
    60
    67.5
    No statistical analyses for this end point

    Secondary: Achievement of weight loss equal to or above 10%

    		 Close Top of page
    End point title
    		 Achievement of weight loss equal to or above 10%
    End point description
    Percentage of subjects who achieved weight loss >= 10 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a subject was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
    End point type
    Secondary
    End point timeframe
    At week 52
    End point values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Number of subjects analysed
    536
    535
    535
    Units: Percentage of subjects
        number (not applicable)
    13.9
    29
    37.2
    No statistical analyses for this end point

    Secondary: Number of adverse events

    		 Close Top of page
    End point title
    		 Number of adverse events
    End point description
    An adverse event (AE) defined as any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or disease (new or exacerbated) temporally associated with the use of an investigational medicinal products (IMP). Results are based on the data from the on-treatment observation period, which was the time period when a subject was on trial treatment, including any period after initiation of rescue medication. Safety Analysis Set (SAS) which comprised all randomised subjects who received at least 1 dose of trial treatment. Overall number of subjects analyzed = subjects with available data for this outcome measure.
    End point type
    Secondary
    End point timeframe
    From baseline (week 0) to follow-up visit (week 73)
    End point values
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Number of subjects analysed
    534
    534
    534
    Units: Events
    1641
    2055
    2115
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Week 0 to week 73
    Adverse event reporting additional description
    Results are based on the safety analysis set which comprised all randomised subjects who received at least 1 dose of trial treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Oral semaglutide 14 mg
    Reporting group description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.

    Reporting group title
    Oral semaglutide 25 mg
    Reporting group description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.

    Reporting group title
    Oral semaglutide 50 mg
    Reporting group description
    		 Subjects were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.

    Serious adverse events
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    53 / 534 (9.93%)
    57 / 534 (10.67%)
    44 / 534 (8.24%)
         number of deaths (all causes)
    1
    6
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic myelomonocytic leukaemia
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 534 (0.00%)
    2 / 534 (0.37%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    2 / 534 (0.37%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hip arthroplasty
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Keratoplasty
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 534 (0.19%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gynaecomastia
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal turbinate hypertrophy
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 534 (0.19%)
    1 / 534 (0.19%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Psychiatric disorders
    Somatic symptom disorder
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brachial plexus injury
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc injury
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenic injury
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute left ventricular failure
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    4 / 534 (0.75%)
    3 / 534 (0.56%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 534 (0.37%)
    1 / 534 (0.19%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 534 (0.19%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Chronic coronary syndrome
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conduction disorder
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 534 (0.37%)
    1 / 534 (0.19%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 534 (0.37%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery occlusion
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 534 (0.19%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Central nervous system lesion
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 534 (0.19%)
    2 / 534 (0.37%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract subcapsular
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epiretinal membrane
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papilloedema
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 534 (0.19%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocele
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 534 (0.37%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 534 (0.19%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 534 (0.19%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder disorder
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Ischaemic skin ulcer
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal hypertension
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    2 / 534 (0.37%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Greater trochanteric pain syndrome
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess oral
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess intestinal
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    3 / 534 (0.56%)
    0 / 534 (0.00%)
    3 / 534 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cellulitis
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 534 (0.37%)
    2 / 534 (0.37%)
    2 / 534 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis pharyngeal
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 534 (0.37%)
    0 / 534 (0.00%)
    2 / 534 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 534 (0.00%)
    0 / 534 (0.00%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 534 (0.19%)
    0 / 534 (0.00%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    1 / 534 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 534 (0.19%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 534 (0.00%)
    2 / 534 (0.37%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 534 (0.00%)
    1 / 534 (0.19%)
    0 / 534 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Oral semaglutide 14 mg Oral semaglutide 25 mg Oral semaglutide 50 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    277 / 534 (51.87%)
    294 / 534 (55.06%)
    314 / 534 (58.80%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    34 / 534 (6.37%)
    28 / 534 (5.24%)
    38 / 534 (7.12%)
         occurrences all number
    63
    81
    81
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    41 / 534 (7.68%)
    26 / 534 (4.87%)
    35 / 534 (6.55%)
         occurrences all number
    44
    30
    40
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    14 / 534 (2.62%)
    27 / 534 (5.06%)
    21 / 534 (3.93%)
         occurrences all number
    25
    34
    27
    Abdominal pain upper
         subjects affected / exposed
    14 / 534 (2.62%)
    32 / 534 (5.99%)
    22 / 534 (4.12%)
         occurrences all number
    17
    52
    55
    Constipation
         subjects affected / exposed
    40 / 534 (7.49%)
    35 / 534 (6.55%)
    33 / 534 (6.18%)
         occurrences all number
    46
    41
    39
    Diarrhoea
         subjects affected / exposed
    66 / 534 (12.36%)
    69 / 534 (12.92%)
    76 / 534 (14.23%)
         occurrences all number
    84
    108
    150
    Dyspepsia
         subjects affected / exposed
    28 / 534 (5.24%)
    29 / 534 (5.43%)
    30 / 534 (5.62%)
         occurrences all number
    32
    47
    50
    Nausea
         subjects affected / exposed
    96 / 534 (17.98%)
    145 / 534 (27.15%)
    146 / 534 (27.34%)
         occurrences all number
    119
    222
    218
    Vomiting
         subjects affected / exposed
    52 / 534 (9.74%)
    91 / 534 (17.04%)
    97 / 534 (18.16%)
         occurrences all number
    69
    155
    184
    Infections and infestations
    COVID-19
         subjects affected / exposed
    63 / 534 (11.80%)
    64 / 534 (11.99%)
    66 / 534 (12.36%)
         occurrences all number
    65
    68
    68
    Nasopharyngitis
         subjects affected / exposed
    24 / 534 (4.49%)
    22 / 534 (4.12%)
    27 / 534 (5.06%)
         occurrences all number
    28
    27
    30
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    38 / 534 (7.12%)
    39 / 534 (7.30%)
    58 / 534 (10.86%)
         occurrences all number
    43
    42
    61

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Nov 2020
    This protocol is amended for the following reasons: 1) The exclusion and discontinuation criteria have been amended to allow simultaneous participation in trials with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or COVID-19 postinfectious conditions. 2) Clarifications for missed doses and treatment compliance, as well as administrative changes were also addressed.
    04 Mar 2021
    This protocol is amended for the following reasons: 1) The exposure-response modelling have been updated based on data available after the completion of the first version of the protocol. 2) Few additional changes such as third-party responsibility and user credentials for IT systems were also addressed.

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

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

    European Medicines Agency © 1995-Fri May 02 06:18:11 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA