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    Clinical Trial Results:
    An open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of AOP2014 and standard first line treatment (BAT) in patients with Polycythemia Vera who previously participated in the PROUD-PV Study

    Summary
    EudraCT number
    		 2014-001357-17
    Trial protocol
    		 HU   AT   CZ   PL   SK   BG   ES   DE  
    Global end of trial date
    29 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Mar 2022
    First version publication date
    30 Mar 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CONTINUATION-PV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AOP Orphan Pharmaceuticals AG
    Sponsor organisation address
    Leopold-Ungar-Platz 2, Wien, Austria, 1190
    Public contact
    Clinical Project Manager, AOP Orphan Pharmaceuticals AG, +43 1503724446, continuation-pv@aoporphan.com
    Scientific contact
    Clinical Project Manager, AOP Orphan Pharmaceuticals AG, +43 1503724446, continuation-pv@aoporphan.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
    19 Jul 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To assess the long-term efficacy of AOP2014 or BAT in terms of disease response rate in patients diagnosed with PV, who were previously treated with AOP2014 or HU in the PROUD-PV study and who completed this Study. • To assess the long-term efficacy including changes in disease burden present during PROUD-PV study in patients diagnosed with PV, who were previously treated with AOP2014 or HU in the PROUD-PV study. Disease burden is defined as disease-related signs (clinically significant splenomegaly) and disease-related symptoms (microvascular disturbances, pruritus, headache), assessed by investigator.
    Protection of trial subjects
    The Investigator obtained a freely given signed ICF, with name and date and time noted by the patient before the patient was exposed to any study-related procedure. The study was carried out in compliance with the principles of Good Clinical Practice (GCP), data protection and confidentiality were handled in compliance with local laws.
    Background therapy
    		 Low dose aspirin (acetylsalicylic acid) (100 mg/day) is to be given to all patients for the duration of study treatment, unless contraindicated.
    Evidence for comparator
    		 The PROUD-PV Study compared the investigational medicinal product (IMP) AOP2014 to HU, an established first-line treatment option currently approved in several European countries for PV patients requiring a cytoreductive therapy (Barbui et al, 2011). This study (CONTINUATION-PV) is a follow-on study designed to provide long-term evaluation of AOP2014 in patients with PV (who received the AOP2014 during the PROUD-PV Study) and of BAT in patients with PV (who received HU during the PROUD-PV Study). The integration of the patients who participated in the PEN-PV Study will contribute to this long-term evaluation of the IMP as well as to an alternative mode of administration (pre-filled injection pen).
    Actual start date of recruitment
    25 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 19
    Country: Number of subjects enrolled
    Bulgaria: 45
    Country: Number of subjects enrolled
    Czechia: 26
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Hungary: 34
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Poland: 27
    Country: Number of subjects enrolled
    Romania: 9
    Country: Number of subjects enrolled
    Russian Federation: 33
    Country: Number of subjects enrolled
    Slovakia: 10
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Ukraine: 30
    Worldwide total number of subjects
    254
    EEA total number of subjects
    191
    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)
    174
    From 65 to 84 years
    79
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients who completed the PROUD-PV Study and fulfilled inclusion criteria were asked to participate in this study.

    Pre-assignment
    Screening details
    		 Patients who completed the PROUD-PV Study and fulfill inclusion and exclusion criteria were enrolled into the study after giving their informed consent. Out of 217 patients who completed the PROUD-PV, 171 patients were enrolled. Because of a serious breach, 2 patients were later excluded from the analyses, 169 patients were included.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AOP2014
    Arm description
    		 Patients treated with AOP2014. The dose of AOP2014 was adjusted to the dose which delivered the optimal disease response.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AOP2014
    Investigational medicinal product code
    ropeginterferon alfa-2b
    Other name
    Peg-P-IFN-α-2b
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    AOP2014 was administered at the starting dose of 100 µg every 2 weeks for up to 12 months of treatment. During the initial treatment phase (first 12 weeks following randomization), the dose of AOP2014 was adjusted to the dose which delivered the optimal disease response (Hematocrit [Hct] <45%, platelets <400 x 109/L and leukocytes <10 x 109/L). If no complete response was achieved, patients were treated at the individual highest tolerable dose, which had been achieved and kept during the maintenance treatment phase.

    Arm title
    		 Control
    Arm description
    		 Patients treated with Hydroxyurea or Best Available Treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hydroxyurea
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Hydroxyurea was administered per os at the starting dose of 500 mg daily for up to 12 months of treatment. During the initial treatment phase (first 12 weeks following randomization), the dose of Hydroxyurea was adjusted to the dose which delivered the optimal disease response (Hematocrit [Hct] <45%, platelets <400 x 109/L and leukocytes <10 x 109/L). If no complete response was achieved, patients were treated at the individual highest tolerable dose, which had been achieved and kept during the maintenance treatment phase.

    Number of subjects in period 1
    		AOP2014 Control
    Started
    127
    127
    EOT in PROUD-PV
    106
    111
    Enrollment to CONTINUATION-PV
    95
    76
    Analysed in CONTINUATION-PV
    95
    74
    Completed
    67
    52
    Not completed
    60
    75
         Consent withdrawn by subject
    4
    6
         Adverse event, continuation not possible
    7
    2
         Completed PROUD-PV but not enrolled in CONTI
    11
    35
         Other
    6
    12
         Lost to follow-up
    2
    2
         Following adverse events
    4
    -
         Serious breach at site
    -
    2
         Discontinued in PROUD-PV
    21
    16
         Lack of efficacy
    3
    -
         Administrative reason
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AOP2014
    Reporting group description
    		 Patients treated with AOP2014. The dose of AOP2014 was adjusted to the dose which delivered the optimal disease response.

    Reporting group title
    Control
    Reporting group description
    		 Patients treated with Hydroxyurea or Best Available Treatment

    Reporting group values
    		 AOP2014 Control Total
    Number of subjects
    		 127 127 254
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 90 84 174
        From 65-84 years
    		 36 43 79
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 60.0 (52.0 to 66.0) 60.0 (48.0 to 67.0) -
    Gender categorical
    Units: Subjects
        Female
    		 68 67 135
        Male
    		 59 60 119
    Race
    Units: Subjects
        White
    		 127 127 254
    Durration of Polycythemia Vera
    Units: month
        arithmetic mean (standard deviation)
    		 12.6 ( 24.70 ) 15.7 ( 25.65 ) -
    Subject analysis sets

    Subject analysis set title
    PROUD+CONTI AOP2014
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All the AOP2014 patients treated in PROUD-PV study, regardless whether they continued to CONTINUATION-PV

    Subject analysis set title
    PROUD+CONTI Control
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All the control patients treated in PROUD-PV study, regardless whether they continued to CONTINUATION-PV

    Subject analysis set title
    CONTI FAS AOP2014
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All AOP2014 patients enrolled to CONTINUATION-PV (without the subjects from the site with serious breach)

    Subject analysis set title
    CONTI FAS Control
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All AOP2014 patients enrolled to CONTINUATION-PV (without the subjects from the site with serious breach)

    Subject analysis set title
    CONTI PPS AOP2014
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subject from the CONTI FAS AOP2014 set who have no protocol deviation which would lead to exclusion from PPS at all assessment visits.

    Subject analysis set title
    CONTI PPS Control
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subject from the CONTI FAS AOP2014 set who have no protocol deviation which would lead to exclusion from PPS at all assessment visits.

    Subject analysis sets values
    		 PROUD+CONTI AOP2014 PROUD+CONTI Control CONTI FAS AOP2014 CONTI FAS Control CONTI PPS AOP2014 CONTI PPS Control
    Number of subjects
    127
    127
    95
    74
    92
    72
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    90
    84
    75
    49
    72
    48
        From 65-84 years
    36
    43
    19
    25
    19
    24
        85 years and over
    1
    0
    1
    0
    1
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    60 (52 to 66)
    60 (48 to 67)
    58 (50 to 64)
    60 (50 to 66)
    58.5 (50.5 to 64)
    60 (50 to 65.5)
    Gender categorical
    Units: Subjects
        Female
    68
    67
    48
    39
    47
    38
        Male
    59
    60
    47
    35
    45
    34
    Race
    Units: Subjects
        White
    127
    127
    95
    74
    92
    72
    Durration of Polycythemia Vera
    Units: month
        arithmetic mean (standard deviation)
    12.6 ( 24.70 )
    15.7 ( 25.65 )
    12.1 ( 25.82 )
    10.1 ( 17.54 )
    12.2 ( 26.18 )
    10.4 ( 17.71 )

    End points

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    End points reporting groups
    Reporting group title
    AOP2014
    Reporting group description
    		 Patients treated with AOP2014. The dose of AOP2014 was adjusted to the dose which delivered the optimal disease response.

    Reporting group title
    Control
    Reporting group description
    		 Patients treated with Hydroxyurea or Best Available Treatment

    Subject analysis set title
    PROUD+CONTI AOP2014
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All the AOP2014 patients treated in PROUD-PV study, regardless whether they continued to CONTINUATION-PV

    Subject analysis set title
    PROUD+CONTI Control
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All the control patients treated in PROUD-PV study, regardless whether they continued to CONTINUATION-PV

    Subject analysis set title
    CONTI FAS AOP2014
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All AOP2014 patients enrolled to CONTINUATION-PV (without the subjects from the site with serious breach)

    Subject analysis set title
    CONTI FAS Control
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All AOP2014 patients enrolled to CONTINUATION-PV (without the subjects from the site with serious breach)

    Subject analysis set title
    CONTI PPS AOP2014
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subject from the CONTI FAS AOP2014 set who have no protocol deviation which would lead to exclusion from PPS at all assessment visits.

    Subject analysis set title
    CONTI PPS Control
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subject from the CONTI FAS AOP2014 set who have no protocol deviation which would lead to exclusion from PPS at all assessment visits.

    Primary: Complete haematologic response with spleen size criterion

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    End point title
    		 Complete haematologic response with spleen size criterion
    End point description
    Disease response defined as haematologic response: Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L, and normal spleen size The discontinued patients are assumed to be Non-responders
    End point type
    Primary
    End point timeframe
    Each assesment visit (each 3 months)
    End point values
    		 AOP2014 Control CONTI FAS AOP2014 CONTI FAS Control CONTI PPS AOP2014 CONTI PPS Control
    Number of subjects analysed
    95
    74
    95
    74
    92
    72
    Units: count and percentage of subject
        Responder at Month 72
    32
    15
    32
    15
    30
    15
        Non-responder at Month 72, including discontinued
    54
    45
    54
    45
    48
    45
        Discontinued at Month 72
    25
    20
    25
    20
    22
    20
    Attachments
    		 Analyses in per-protocol set
    Analysis in Full-analyses set
    Statistical analysis title
    		 Longitudinal analysis over 0 - 72 months FAS
    Statistical analysis description
    Longitudinal analysis to evaluate trends over treatment period of 72 months.
    Comparison groups
    CONTI FAS AOP2014 v CONTI FAS Control
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.1289 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 2.46
    Variability estimate
    Standard error of the mean
    Notes
    [1] - Study the trend in responses in the treatment period
    [2] - The goal was to study the trend through the years. The p-value in late months is higher because of high number of discontinued patients (= Non-responders). Check the attachment for more information.
    Statistical analysis title
    		 Longitudinal analysis over 0 - 72 months PPS
    Statistical analysis description
    Longitudinal analysis to evaluate trends over treatment period of 72 months.
    Comparison groups
    CONTI PPS AOP2014 v CONTI PPS Control
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.0987 [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 2.55
    Variability estimate
    Standard error of the mean
    Notes
    [3] - Study the trend in responses in the treatment period
    [4] - The goal was to study the trend through the years. The p-value in late months is higher because of high number of discontinued patients (= Non-responders). Check the attachment for more information.

    Primary: Complete haematologic response and improvement of disease burden

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    End point title
    		 Complete haematologic response and improvement of disease burden
    End point description
    Disease response defined as haematologic response (Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L), resolution and/or clinically improvement of disease-related signs (clinically significant splenomegaly) and disease-related symptoms (microvascular disturbances, pruritus, headache).
    End point type
    Primary
    End point timeframe
    Each assesment visit (each 3 months)
    End point values
    		 AOP2014 Control CONTI FAS AOP2014 CONTI FAS Control CONTI PPS AOP2014 CONTI PPS Control
    Number of subjects analysed
    95
    74
    95
    74
    92
    72
    Units: count and percentage of subject
        Responder at Month 72
    35
    17
    35
    17
    35
    15
        Non-responder at Month 72, including discontinued
    53
    49
    53
    49
    43
    45
        Discontinued at Month 72
    25
    20
    25
    20
    22
    20
    Attachments
    		 Analysis in Full-analyses set
    Analysis in Per-protocol set
    Statistical analysis title
    		 Longitudinal analysis over 0 - 72 months FAS
    Statistical analysis description
    Longitudinal analysis to evaluate trends over treatment period of 72 months.
    Comparison groups
    CONTI FAS Control v CONTI FAS AOP2014
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.0584 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 2.52
    Variability estimate
    Standard error of the mean
    Notes
    [5] - Study the trend in responses in the treatment period
    [6] - The goal was to study the trend through the years. The p-value in late months is higher because of high number of discontinued patients (= Non-responders). Check the attachment for more information.
    Statistical analysis title
    		 Longitudinal analysis over 0 - 72 months PPS
    Statistical analysis description
    Longitudinal analysis to evaluate trends over treatment period of 72 months.
    Comparison groups
    CONTI PPS AOP2014 v CONTI PPS Control
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.0167 [8]
    Method
    		 Mixed models analysis
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 2.97
    Variability estimate
    Standard error of the mean
    Notes
    [7] - Study the trend in responses in the treatment period
    [8] - The goal was to study the trend through the years. The p-value in late months is higher because of high number of discontinued patients (= Non-responders). Check the attachment for more information.

    Secondary: Complete haematologic response (without spleen size criterion)

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    End point title
    		 Complete haematologic response (without spleen size criterion)
    End point description
    Disease response defined as haematologic response: Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L. The discontinued patients are assumed to be Non-responders
    End point type
    Secondary
    End point timeframe
    Each assesment visit (each 3 months)
    End point values
    		 AOP2014 Control CONTI FAS AOP2014 CONTI FAS Control CONTI PPS AOP2014 CONTI PPS Control
    Number of subjects analysed
    95
    74
    95
    74
    92
    72
    Units: count and percentage of subject
        Responder at Month 72
    48
    22
    48
    22
    45
    19
        Non-responder at Month 72, including discontinued
    40
    41
    40
    41
    33
    41
        Discontinued at Month 72
    25
    20
    25
    20
    22
    20
    Attachments
    		 Analysis in Full-analyses set
    Analysis in Per-protocol set
    Statistical analysis title
    		 Longitudinal analysis over 0 - 72 months FAS
    Statistical analysis description
    Longitudinal analysis to evaluate trends over treatment period of 72 months.
    Comparison groups
    CONTI FAS AOP2014 v CONTI FAS Control
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.0216 [10]
    Method
    		 Mixed models analysis
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 2.26
    Variability estimate
    Standard error of the mean
    Notes
    [9] - Study the trend in responses in the treatment period
    [10] - The goal was to study the trend through the years. The p-value in late months is higher because of high number of discontinued patients (= Non-responders). Check the attachment for more information.
    Statistical analysis title
    		 Longitudinal analysis over 0 - 72 months PPS
    Statistical analysis description
    Longitudinal analysis to evaluate trends over treatment period of 72 months. in per-protocol set.
    Comparison groups
    CONTI PPS AOP2014 v CONTI PPS Control
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.0034 [12]
    Method
    		 Mixed models analysis
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.22
         upper limit
    		 2.74
    Variability estimate
    Standard error of the mean
    Notes
    [11] - Study the trend in responses in the treatment period
    [12] - The goal was to study the trend through the years. The p-value in late months is higher because of high number of discontinued patients (= Non-responders). Check the attachment for more information.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    AOP2014
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Serious adverse events
    		 AOP2014 Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 127 (25.20%)
    35 / 127 (27.56%)
         number of deaths (all causes)
    3
    5
         number of deaths resulting from adverse events
    3
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
    Additional description: Acute leukaemia
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Adrenal adenoma
    Additional description: Adrenal adenoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct cancer
    Additional description: Bile duct cancer
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm malignant
    Additional description: Brain neoplasm malignant
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
    Additional description: Colon cancer
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
    Additional description: Glioblastoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant melanoma
    Additional description: Malignant melanoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelofibrosis
    Additional description: Myelofibrosis
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm of appendix
    Additional description: Neoplasm of appendix
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
    Additional description: Rectal adenocarcinoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal oncocytoma
    Additional description: Renal oncocytoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spermatocytic seminoma
    Additional description: Spermatocytic seminoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid adenoma
    Additional description: Thyroid adenoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Embolism
    Additional description: Embolism
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
    Additional description: Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
    Additional description: Thrombophlebitis superficial
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Aortic valve replacement
    Additional description: Aortic valve replacement
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid endarterectomy
    Additional description: Carotid endarterectomy
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
    Additional description: Cholecystectomy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colectomy
    Additional description: Colectomy
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve operation
    Additional description: Heart valve operation
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
    Additional description: Hip arthroplasty
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
    Additional description: Knee arthroplasty
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee operation
    Additional description: Knee operation
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rehabilitation therapy
    Additional description: Rehabilitation therapy
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst excision
    Additional description: Renal cyst excision
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder arthroplasty
    Additional description: Shoulder arthroplasty
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-organ failure
    Additional description: Multi-organ failure
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
    Additional description: Death
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
    Additional description: Sudden death
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Uterine polyp
    Additional description: Uterine polyp
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
    Additional description: Depression
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Angiocardiogram
    Additional description: Angiocardiogram
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulation time prolonged
    Additional description: Coagulation time prolonged
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
    Additional description: Fall
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis radiation
    Additional description: Gastroenteritis radiation
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
    Additional description: Post procedural haemorrhage
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
    Additional description: Road traffic accident
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Skin laceration
    Additional description: Skin laceration
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
    Additional description: Skull fractured base
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous haematoma
    Additional description: Subcutaneous haematoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
    Additional description: Upper limb fracture
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine dehiscence
    Additional description: Uterine dehiscence
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Porphyria non-acute
    Additional description: Porphyria non-acute
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
    Additional description: Angina unstable
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    3 / 127 (2.36%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    0 / 127 (0.00%)
    3 / 127 (2.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
    Additional description: Cardiac failure acute
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
    Additional description: Cardiac failure chronic
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
    Additional description: Left ventricular failure
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Supraventricular tachycardia
    Additional description: Supraventricular tachycardia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
    Additional description: Sinus tachycardia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
    Additional description: Cerebrovascular accident
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
    Additional description: Encephalopathy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic transformation stroke
    Additional description: Haemorrhagic transformation stroke
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
    Additional description: Ischaemic stroke
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulocytopenia
    Additional description: Granulocytopenia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
    Additional description: Leukopenia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic anaemia
    Additional description: Microcytic anaemia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal
    Additional description: Diverticulum intestinal
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
    Additional description: Inguinal hernia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
    Additional description: Cholecystitis acute
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
    Additional description: Skin ulcer
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical haematoma
    Additional description: Umbilical haematoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
    Additional description: Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
    Additional description: Calculus urinary
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
    Additional description: Rheumatoid arthritis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
    Additional description: Appendicitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
    Additional description: COVID-19
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis infective
    Additional description: Cholangitis infective
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
    Additional description: Diverticulitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    3 / 127 (2.36%)
    3 / 127 (2.36%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pneumonia viral
    Additional description: Pneumonia viral
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
    Additional description: Pseudomembranous colitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
    Additional description: Pyelonephritis acute
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    Additional description: Sepsis
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Septic shock
    Additional description: Septic shock
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
    Additional description: Tuberculosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 AOP2014 Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    115 / 127 (90.55%)
    117 / 127 (92.13%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenal adenoma
    Additional description: Adrenal adenoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Angiolipoma
    Additional description: Angiolipoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Adrenal neoplasm
    Additional description: Adrenal neoplasm
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Angiomyolipoma
    Additional description: Angiomyolipoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Benign neoplasm of thyroid gland
    Additional description: Benign neoplasm of thyroid gland
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Bile duct cancer
    Additional description: Bile duct cancer
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Blepharal papilloma
    Additional description: Blepharal papilloma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Colon adenoma
    Additional description: Colon adenoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Fibrous histiocytoma
    Additional description: Fibrous histiocytoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    2
    Haemangioma of liver
    Additional description: Haemangioma of liver
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Intestinal adenocarcinoma
    Additional description: Intestinal adenocarcinoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Keratoacanthoma
    Additional description: Keratoacanthoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Lipoma
    Additional description: Lipoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Myelofibrosis
    Additional description: Myelofibrosis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Primary myelofibrosis
    Additional description: Primary myelofibrosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Prostate cancer
    Additional description: Prostate cancer
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Prostatic adenoma
    Additional description: Prostatic adenoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Uterine leiomyoma
    Additional description: Uterine leiomyoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Vascular disorders
    Aneurysm
    Additional description: Aneurysm
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Aortic stenosis
    Additional description: Aortic stenosis
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Blood pressure fluctuation
    Additional description: Blood pressure fluctuation
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Circulatory collapse
    Additional description: Circulatory collapse
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Erythromelalgia
    Additional description: Erythromelalgia
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Femoral artery occlusion
    Additional description: Femoral artery occlusion
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    2 / 127 (1.57%)
    4 / 127 (3.15%)
         occurrences all number
    2
    5
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    7 / 127 (5.51%)
    12 / 127 (9.45%)
         occurrences all number
    12
    14
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    3
    1
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    3
    1
    Peripheral arterial occlusive disease
    Additional description: Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Peripheral artery stenosis
    Additional description: Peripheral artery stenosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Peripheral circulatory failure
    Additional description: Peripheral circulatory failure
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Peripheral coldness
    Additional description: Peripheral coldness
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Phlebitis
    Additional description: Phlebitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Raynaud's phenomenon
    Additional description: Raynaud's phenomenon
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Subclavian steal syndrome
    Additional description: Subclavian steal syndrome
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Thrombophlebitis
    Additional description: Thrombophlebitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Varicose vein
    Additional description: Varicose vein
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Vascular pain
    Additional description: Vascular pain
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Venous thrombosis limb
    Additional description: Venous thrombosis limb
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Blepharoplasty
    Additional description: Blepharoplasty
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Carpal tunnel decompression
    Additional description: Carpal tunnel decompression
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Cataract operation
    Additional description: Cataract operation
         subjects affected / exposed
    2 / 127 (1.57%)
    5 / 127 (3.94%)
         occurrences all number
    3
    6
    Endocervical curettage
    Additional description: Endocervical curettage
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Eye operation
    Additional description: Eye operation
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Intraocular lens implant
    Additional description: Intraocular lens implant
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Maxillofacial operation
    Additional description: Maxillofacial operation
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Ovarian cystectomy
    Additional description: Ovarian cystectomy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Peripheral endarterectomy
    Additional description: Peripheral endarterectomy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Polypectomy
    Additional description: Polypectomy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Proctectomy
    Additional description: Proctectomy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Prostatic operation
    Additional description: Prostatic operation
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Skin neoplasm excision
    Additional description: Skin neoplasm excision
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Tooth extraction
    Additional description: Tooth extraction
         subjects affected / exposed
    6 / 127 (4.72%)
    2 / 127 (1.57%)
         occurrences all number
    7
    2
    General disorders and administration site conditions
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    11 / 127 (8.66%)
    7 / 127 (5.51%)
         occurrences all number
    20
    24
    Axillary pain
    Additional description: Axillary pain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Chest discomfort
    Additional description: Chest discomfort
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    5 / 127 (3.94%)
    1 / 127 (0.79%)
         occurrences all number
    5
    1
    Chills
    Additional description: Chills
         subjects affected / exposed
    3 / 127 (2.36%)
    2 / 127 (1.57%)
         occurrences all number
    3
    2
    Condition aggravated
    Additional description: Condition aggravated
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Cyst
    Additional description: Cyst
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Drug intolerance
    Additional description: Drug intolerance
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Facial pain
    Additional description: Facial pain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    4
    0
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    17 / 127 (13.39%)
    21 / 127 (16.54%)
         occurrences all number
    47
    27
    Feeling cold
    Additional description: Feeling cold
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    3
    Impaired healing
    Additional description: Impaired healing
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Inflammation
    Additional description: Inflammation
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Influenza like illness
    Additional description: Influenza like illness
         subjects affected / exposed
    10 / 127 (7.87%)
    3 / 127 (2.36%)
         occurrences all number
    16
    3
    Injection site erythema
    Additional description: Injection site erythema
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Injection site haematoma
    Additional description: Injection site haematoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Injection site pain
    Additional description: Injection site pain
         subjects affected / exposed
    3 / 127 (2.36%)
    0 / 127 (0.00%)
         occurrences all number
    4
    0
    Injection site pruritus
    Additional description: Injection site pruritus
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Injection site reaction
    Additional description: Injection site reaction
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Injection site warmth
    Additional description: Injection site warmth
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    3
    2
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    5 / 127 (3.94%)
    4 / 127 (3.15%)
         occurrences all number
    5
    4
    Pain
    Additional description: Pain
         subjects affected / exposed
    1 / 127 (0.79%)
    4 / 127 (3.15%)
         occurrences all number
    1
    5
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Puncture site pain
    Additional description: Puncture site pain
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    13 / 127 (10.24%)
    6 / 127 (4.72%)
         occurrences all number
    21
    7
    Sensation of foreign body
    Additional description: Sensation of foreign body
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Soft tissue inflammation
    Additional description: Soft tissue inflammation
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Thirst
    Additional description: Thirst
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Immune system disorders
    Allergy to arthropod sting
    Additional description: Allergy to arthropod sting
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Drug hypersensitivity
    Additional description: Drug hypersensitivity
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Sarcoidosis
    Additional description: Sarcoidosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
    Additional description: Seasonal allergy
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Social circumstances
    Stress at work
    Additional description: Stress at work
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Acquired phimosis
    Additional description: Acquired phimosis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Amenorrhoea
    Additional description: Amenorrhoea
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Benign prostatic hyperplasia
    Additional description: Benign prostatic hyperplasia
         subjects affected / exposed
    5 / 127 (3.94%)
    0 / 127 (0.00%)
         occurrences all number
    5
    0
    Breast disorder
    Additional description: Breast disorder
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Breast pain
    Additional description: Breast pain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Endometrial dysplasia
    Additional description: Endometrial dysplasia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Erectile dysfunction
    Additional description: Erectile dysfunction
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Fibrocystic breast disease
    Additional description: Fibrocystic breast disease
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Haematospermia
    Additional description: Haematospermia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Metrorrhagia
    Additional description: Metrorrhagia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Menstruation irregular
    Additional description: Menstruation irregular
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Ovarian cyst
    Additional description: Ovarian cyst
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Prostatitis
    Additional description: Prostatitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Uterine cervical erosion
    Additional description: Uterine cervical erosion
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Uterine haemorrhage
    Additional description: Uterine haemorrhage
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Vaginal haemorrhage
    Additional description: Vaginal haemorrhage
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Cough
    Additional description: Cough
         subjects affected / exposed
    11 / 127 (8.66%)
    11 / 127 (8.66%)
         occurrences all number
    19
    12
    Dysphonia
    Additional description: Dysphonia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    2 / 127 (1.57%)
    2 / 127 (1.57%)
         occurrences all number
    2
    2
    Dyspnoea exertional
    Additional description: Dyspnoea exertional
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    2 / 127 (1.57%)
    2 / 127 (1.57%)
         occurrences all number
    3
    2
    Increased bronchial secretion
    Additional description: Increased bronchial secretion
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Lung infiltration
    Additional description: Lung infiltration
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    7 / 127 (5.51%)
    3 / 127 (2.36%)
         occurrences all number
    10
    3
    Pneumonitis
    Additional description: Pneumonitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Pulmonary hypertension
    Additional description: Pulmonary hypertension
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Pulmonary microemboli
    Additional description: Pulmonary microemboli
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Rales
    Additional description: Rales
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
    Additional description: Rhinitis allergic
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Rhinitis atrophic
    Additional description: Rhinitis atrophic
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Sneezing
    Additional description: Sneezing
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Throat irritation
    Additional description: Throat irritation
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Affective disorder
    Additional description: Affective disorder
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    3
    1
    Agitation
    Additional description: Agitation
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    5 / 127 (3.94%)
    4 / 127 (3.15%)
         occurrences all number
    8
    4
    Anxiety disorder
    Additional description: Anxiety disorder
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Apathy
    Additional description: Apathy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Depressed mood
    Additional description: Depressed mood
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Depression
    Additional description: Depression
         subjects affected / exposed
    3 / 127 (2.36%)
    4 / 127 (3.15%)
         occurrences all number
    3
    4
    Emotional distress
    Additional description: Emotional distress
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Hallucination
    Additional description: Hallucination
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    4 / 127 (3.15%)
    7 / 127 (5.51%)
         occurrences all number
    4
    9
    Irritability
    Additional description: Irritability
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Libido increased
    Additional description: Libido increased
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    3
    Mood altered
    Additional description: Mood altered
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Mood swings
    Additional description: Mood swings
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Nervousness
    Additional description: Nervousness
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Panic attack
    Additional description: Panic attack
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Restlessness
    Additional description: Restlessness
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Sleep disorder
    Additional description: Sleep disorder
         subjects affected / exposed
    3 / 127 (2.36%)
    2 / 127 (1.57%)
         occurrences all number
    3
    2
    Hepatobiliary disorders
    Biliary colic
    Additional description: Biliary colic
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Cholecystitis
    Additional description: Cholecystitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Cholecystitis chronic
    Additional description: Cholecystitis chronic
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    4 / 127 (3.15%)
    3 / 127 (2.36%)
         occurrences all number
    4
    3
    Gallbladder cholesterolosis
    Additional description: Gallbladder cholesterolosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Gallbladder disorder
    Additional description: Gallbladder disorder
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Gallbladder polyp
    Additional description: Gallbladder polyp
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Hepatic cyst
    Additional description: Hepatic cyst
         subjects affected / exposed
    3 / 127 (2.36%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Hepatic steatosis
    Additional description: Hepatic steatosis
         subjects affected / exposed
    4 / 127 (3.15%)
    1 / 127 (0.79%)
         occurrences all number
    4
    1
    Hepatitis toxic
    Additional description: Hepatitis toxic
         subjects affected / exposed
    3 / 127 (2.36%)
    0 / 127 (0.00%)
         occurrences all number
    4
    0
    Hepatomegaly
    Additional description: Hepatomegaly
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Hepatosplenomegaly
    Additional description: Hepatosplenomegaly
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Hyperbilirubinaemia
    Additional description: Hyperbilirubinaemia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    2
    Liver disorder
    Additional description: Liver disorder
         subjects affected / exposed
    2 / 127 (1.57%)
    2 / 127 (1.57%)
         occurrences all number
    3
    2
    Pneumobilia
    Additional description: Pneumobilia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Portal hypertension
    Additional description: Portal hypertension
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Steatohepatitis
    Additional description: Steatohepatitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
         subjects affected / exposed
    19 / 127 (14.96%)
    2 / 127 (1.57%)
         occurrences all number
    40
    2
    Anti-thyroid antibody positive
    Additional description: Anti-thyroid antibody positive
         subjects affected / exposed
    3 / 127 (2.36%)
    0 / 127 (0.00%)
         occurrences all number
    6
    0
    Antinuclear antibody increased
    Additional description: Antinuclear antibody increased
         subjects affected / exposed
    4 / 127 (3.15%)
    3 / 127 (2.36%)
         occurrences all number
    4
    3
    Aspartate aminotransferase increased
    Additional description: Aspartate aminotransferase increased
         subjects affected / exposed
    17 / 127 (13.39%)
    2 / 127 (1.57%)
         occurrences all number
    27
    2
    Blood alkaline phosphatase increased
    Additional description: Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    6
    1
    Blood bilirubin increased
    Additional description: Blood bilirubin increased
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Blood creatine phosphokinase increased
    Additional description: Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    6
    1
    Blood fibrinogen decreased
    Additional description: Blood fibrinogen decreased
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    2
    Blood glucose increased
    Additional description: Blood glucose increased
         subjects affected / exposed
    0 / 127 (0.00%)
    3 / 127 (2.36%)
         occurrences all number
    0
    3
    Blood iron decreased
    Additional description: Blood iron decreased
         subjects affected / exposed
    1 / 127 (0.79%)
    4 / 127 (3.15%)
         occurrences all number
    1
    4
    Blood lactate dehydrogenase increased
    Additional description: Blood lactate dehydrogenase increased
         subjects affected / exposed
    3 / 127 (2.36%)
    2 / 127 (1.57%)
         occurrences all number
    4
    2
    Blood phosphorus decreased
    Additional description: Blood phosphorus decreased
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Blood potassium increased
    Additional description: Blood potassium increased
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Blood potassium decreased
    Additional description: Blood potassium decreased
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Blood pressure abnormal
    Additional description: Blood pressure abnormal
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Blood pressure diastolic increased
    Additional description: Blood pressure diastolic increased
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Blood pressure systolic increased
    Additional description: Blood pressure systolic increased
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
    Additional description: Blood pressure increased
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    2
    Blood thyroid stimulating hormone increased
    Additional description: Blood thyroid stimulating hormone increased
         subjects affected / exposed
    5 / 127 (3.94%)
    1 / 127 (0.79%)
         occurrences all number
    6
    4
    Blood triglycerides increased
    Additional description: Blood triglycerides increased
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Blood urea increased
    Additional description: Blood urea increased
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    7
    1
    Blood uric acid increased
    Additional description: Blood uric acid increased
         subjects affected / exposed
    4 / 127 (3.15%)
    2 / 127 (1.57%)
         occurrences all number
    4
    2
    Body temperature decreased
    Additional description: Body temperature decreased
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Body temperature increased
    Additional description: Body temperature increased
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    3
    1
    Colonoscopy
    Additional description: Colonoscopy
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Computerised tomogram
    Additional description: Computerised tomogram
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Eastern Cooperative Oncology Group performance status worsened
    Additional description: Eastern Cooperative Oncology Group performance status worsened
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Electrocardiogram PR prolongation
    Additional description: Electrocardiogram PR prolongation
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Ejection fraction decreased
    Additional description: Ejection fraction decreased
         subjects affected / exposed
    4 / 127 (3.15%)
    1 / 127 (0.79%)
         occurrences all number
    4
    1
    Electrocardiogram QT interval abnormal
    Additional description: Electrocardiogram QT interval abnormal
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram QT prolonged
    Additional description: Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Endoscopy upper gastrointestinal tract
    Additional description: Endoscopy upper gastrointestinal tract
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
    Additional description: Gamma-glutamyltransferase increased
         subjects affected / exposed
    28 / 127 (22.05%)
    5 / 127 (3.94%)
         occurrences all number
    91
    5
    Haematocrit decreased
    Additional description: Haematocrit decreased
         subjects affected / exposed
    1 / 127 (0.79%)
    4 / 127 (3.15%)
         occurrences all number
    1
    5
    Haematocrit increased
    Additional description: Haematocrit increased
         subjects affected / exposed
    6 / 127 (4.72%)
    5 / 127 (3.94%)
         occurrences all number
    11
    7
    Haemoglobin decreased
    Additional description: Haemoglobin decreased
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
    Additional description: Hepatic enzyme increased
         subjects affected / exposed
    8 / 127 (6.30%)
    1 / 127 (0.79%)
         occurrences all number
    16
    2
    Lipase increased
    Additional description: Lipase increased
         subjects affected / exposed
    2 / 127 (1.57%)
    2 / 127 (1.57%)
         occurrences all number
    7
    2
    Lymphocyte count decreased
    Additional description: Lymphocyte count decreased
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Magnetic resonance imaging
    Additional description: Magnetic resonance imaging
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Mean cell volume increased
    Additional description: Mean cell volume increased
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Neutrophil count increased
    Additional description: Neutrophil count increased
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Nitrite urine present
    Additional description: Nitrite urine present
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Platelet count decreased
    Additional description: Platelet count decreased
         subjects affected / exposed
    3 / 127 (2.36%)
    12 / 127 (9.45%)
         occurrences all number
    5
    21
    Platelet count increased
    Additional description: Platelet count increased
         subjects affected / exposed
    3 / 127 (2.36%)
    2 / 127 (1.57%)
         occurrences all number
    3
    2
    Scan with contrast
    Additional description: Scan with contrast
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Serum ferritin decreased
    Additional description: Serum ferritin decreased
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Transaminases increased
    Additional description: Transaminases increased
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Transferrin decreased
    Additional description: Transferrin decreased
         subjects affected / exposed
    2 / 127 (1.57%)
    2 / 127 (1.57%)
         occurrences all number
    3
    3
    Visual acuity tests abnormal
    Additional description: Visual acuity tests abnormal
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Urine analysis abnormal
    Additional description: Urine analysis abnormal
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    4
    1
    White blood cell count decreased
    Additional description: White blood cell count decreased
         subjects affected / exposed
    5 / 127 (3.94%)
    5 / 127 (3.94%)
         occurrences all number
    12
    9
    White blood cell count increased
    Additional description: White blood cell count increased
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    White blood cells urine positive
    Additional description: White blood cells urine positive
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Accidental overdose
    Additional description: Accidental overdose
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Animal bite
    Additional description: Animal bite
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Anaemia postoperative
    Additional description: Anaemia postoperative
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Ankle fracture
    Additional description: Ankle fracture
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Arthropod bite
    Additional description: Arthropod bite
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Contrast media reaction
    Additional description: Contrast media reaction
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Contusion
    Additional description: Contusion
         subjects affected / exposed
    1 / 127 (0.79%)
    3 / 127 (2.36%)
         occurrences all number
    1
    5
    Fall
    Additional description: Fall
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Foot fracture
    Additional description: Foot fracture
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorder postoperative
    Additional description: Gastrointestinal disorder postoperative
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Forearm fracture
    Additional description: Forearm fracture
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Incisional hernia
    Additional description: Incisional hernia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Joint dislocation
    Additional description: Joint dislocation
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Joint injury
    Additional description: Joint injury
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
    Additional description: Ligament sprain
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Muscle strain
    Additional description: Muscle strain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Limb injury
    Additional description: Limb injury
         subjects affected / exposed
    2 / 127 (1.57%)
    2 / 127 (1.57%)
         occurrences all number
    2
    2
    Overdose
    Additional description: Overdose
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Postoperative wound complication
    Additional description: Postoperative wound complication
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Retinal injury
    Additional description: Retinal injury
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Road traffic accident
    Additional description: Road traffic accident
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Thermal burn
    Additional description: Thermal burn
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Subcutaneous haematoma
    Additional description: Subcutaneous haematoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Tibia fracture
    Additional description: Tibia fracture
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Traumatic haematoma
    Additional description: Traumatic haematoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Wound
    Additional description: Wound
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Cataract congenital
    Additional description: Cataract congenital
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Marfan's syndrome
    Additional description: Marfan's syndrome
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Angina pectoris
    Additional description: Angina pectoris
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    4
    0
    Aortic valve calcification
    Additional description: Aortic valve calcification
         subjects affected / exposed
    0 / 127 (0.00%)
    3 / 127 (2.36%)
         occurrences all number
    0
    3
    Arrhythmia
    Additional description: Arrhythmia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    4 / 127 (3.15%)
    4 / 127 (3.15%)
         occurrences all number
    4
    14
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Atrioventricular block second degree
    Additional description: Atrioventricular block second degree
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Bundle branch block left
    Additional description: Bundle branch block left
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    3
    1
    Cardiac failure chronic
    Additional description: Cardiac failure chronic
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Cyanosis
    Additional description: Cyanosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Dilatation ventricular
    Additional description: Dilatation ventricular
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Extrasystoles
    Additional description: Extrasystoles
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Heart valve incompetence
    Additional description: Heart valve incompetence
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Hepatojugular reflux
    Additional description: Hepatojugular reflux
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Intracardiac thrombus
    Additional description: Intracardiac thrombus
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Mitral valve calcification
    Additional description: Mitral valve calcification
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Mitral valve incompetence
    Additional description: Mitral valve incompetence
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Pericardial cyst
    Additional description: Pericardial cyst
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    4
    1
    Right atrial enlargement
    Additional description: Right atrial enlargement
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Sinoatrial block
    Additional description: Sinoatrial block
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Sinus tachycardia
    Additional description: Sinus tachycardia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Supraventricular extrasystoles
    Additional description: Supraventricular extrasystoles
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    3
    Tachycardia
    Additional description: Tachycardia
         subjects affected / exposed
    4 / 127 (3.15%)
    2 / 127 (1.57%)
         occurrences all number
    4
    3
    Tricuspid valve incompetence
    Additional description: Tricuspid valve incompetence
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Ventricular extrasystoles
    Additional description: Ventricular extrasystoles
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    5
    Ventricular tachycardia
    Additional description: Ventricular tachycardia
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Nervous system disorders
    Burning sensation
    Additional description: Burning sensation
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    2
    Carotid artery stenosis
    Additional description: Carotid artery stenosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Diabetic neuropathy
    Additional description: Diabetic neuropathy
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Carpal tunnel syndrome
    Additional description: Carpal tunnel syndrome
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    14 / 127 (11.02%)
    11 / 127 (8.66%)
         occurrences all number
    25
    16
    Dysgeusia
    Additional description: Dysgeusia
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Encephalopathy
    Additional description: Encephalopathy
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Head discomfort
    Additional description: Head discomfort
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Headache
    Additional description: Headache
         subjects affected / exposed
    16 / 127 (12.60%)
    18 / 127 (14.17%)
         occurrences all number
    34
    28
    Hypoaesthesia
    Additional description: Hypoaesthesia
         subjects affected / exposed
    4 / 127 (3.15%)
    0 / 127 (0.00%)
         occurrences all number
    6
    0
    Intercostal neuralgia
    Additional description: Intercostal neuralgia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Loss of consciousness
    Additional description: Loss of consciousness
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Lumbar radiculopathy
    Additional description: Lumbar radiculopathy
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    2
    Memory impairment
    Additional description: Memory impairment
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Migraine
    Additional description: Migraine
         subjects affected / exposed
    4 / 127 (3.15%)
    0 / 127 (0.00%)
         occurrences all number
    4
    0
    Migraine with aura
    Additional description: Migraine with aura
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Neuralgia
    Additional description: Neuralgia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Neuropathy peripheral
    Additional description: Neuropathy peripheral
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    0 / 127 (0.00%)
    5 / 127 (3.94%)
         occurrences all number
    0
    6
    Parosmia
    Additional description: Parosmia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Post herpetic neuralgia
    Additional description: Post herpetic neuralgia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Peripheral nerve lesion
    Additional description: Peripheral nerve lesion
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Radiculopathy
    Additional description: Radiculopathy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Sinus headache
    Additional description: Sinus headache
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Somnolence
    Additional description: Somnolence
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Tension headache
    Additional description: Tension headache
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Tremor
    Additional description: Tremor
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Trigeminal neuritis
    Additional description: Trigeminal neuritis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    21 / 127 (16.54%)
    37 / 127 (29.13%)
         occurrences all number
    41
    67
    Blood loss anaemia
    Additional description: Blood loss anaemia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Cytopenia
    Additional description: Cytopenia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Granulocytopenia
    Additional description: Granulocytopenia
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Iron deficiency anaemia
    Additional description: Iron deficiency anaemia
         subjects affected / exposed
    4 / 127 (3.15%)
    0 / 127 (0.00%)
         occurrences all number
    9
    0
    Leukocytosis
    Additional description: Leukocytosis
         subjects affected / exposed
    0 / 127 (0.00%)
    4 / 127 (3.15%)
         occurrences all number
    0
    5
    Leukopenia
    Additional description: Leukopenia
         subjects affected / exposed
    27 / 127 (21.26%)
    31 / 127 (24.41%)
         occurrences all number
    148
    82
    Lymphadenitis
    Additional description: Lymphadenitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Lymphadenopathy
    Additional description: Lymphadenopathy
         subjects affected / exposed
    0 / 127 (0.00%)
    3 / 127 (2.36%)
         occurrences all number
    0
    3
    Microcytic anaemia
    Additional description: Microcytic anaemia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    6 / 127 (4.72%)
    7 / 127 (5.51%)
         occurrences all number
    7
    14
    Pancytopenia
    Additional description: Pancytopenia
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    4
    0
    Polycythaemia
    Additional description: Polycythaemia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Splenic cyst
    Additional description: Splenic cyst
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Splenic infarction
    Additional description: Splenic infarction
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Splenomegaly
    Additional description: Splenomegaly
         subjects affected / exposed
    13 / 127 (10.24%)
    8 / 127 (6.30%)
         occurrences all number
    13
    8
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    28 / 127 (22.05%)
    37 / 127 (29.13%)
         occurrences all number
    81
    101
    Thrombocytosis
    Additional description: Thrombocytosis
         subjects affected / exposed
    1 / 127 (0.79%)
    3 / 127 (2.36%)
         occurrences all number
    2
    4
    Ear and labyrinth disorders
    Cerumen impaction
    Additional description: Cerumen impaction
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Deafness neurosensory
    Additional description: Deafness neurosensory
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    2
    Ear discomfort
    Additional description: Ear discomfort
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
    Additional description: Tinnitus
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    8
    1
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    5 / 127 (3.94%)
    8 / 127 (6.30%)
         occurrences all number
    5
    9
    Vestibular disorder
    Additional description: Vestibular disorder
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Eye disorders
    Age-related macular degeneration
    Additional description: Age-related macular degeneration
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Asthenopia
    Additional description: Asthenopia
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Blepharitis
    Additional description: Blepharitis
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Blepharochalasis
    Additional description: Blepharochalasis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Cataract
    Additional description: Cataract
         subjects affected / exposed
    7 / 127 (5.51%)
    3 / 127 (2.36%)
         occurrences all number
    8
    4
    Chalazion
    Additional description: Chalazion
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Conjunctival haemorrhage
    Additional description: Conjunctival haemorrhage
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Corneal opacity
    Additional description: Corneal opacity
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Diabetic retinopathy
    Additional description: Diabetic retinopathy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Dry eye
    Additional description: Dry eye
         subjects affected / exposed
    7 / 127 (5.51%)
    3 / 127 (2.36%)
         occurrences all number
    7
    3
    Ectropion
    Additional description: Ectropion
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Eye haemorrhage
    Additional description: Eye haemorrhage
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Eye inflammation
    Additional description: Eye inflammation
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Eye irritation
    Additional description: Eye irritation
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Eye pain
    Additional description: Eye pain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Eye pruritus
    Additional description: Eye pruritus
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Eyelid ptosis
    Additional description: Eyelid ptosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Eyelid skin dryness
    Additional description: Eyelid skin dryness
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Iridocyclitis
    Additional description: Iridocyclitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Keratopathy
    Additional description: Keratopathy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Maculopathy
    Additional description: Maculopathy
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Myopia
    Additional description: Myopia
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Posterior capsule opacification
    Additional description: Posterior capsule opacification
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Presbyopia
    Additional description: Presbyopia
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Retinopathy
    Additional description: Retinopathy
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Retinopathy hypertensive
    Additional description: Retinopathy hypertensive
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
    Additional description: Vision blurred
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Visual acuity reduced
    Additional description: Visual acuity reduced
         subjects affected / exposed
    3 / 127 (2.36%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Vitreous haemorrhage
    Additional description: Vitreous haemorrhage
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    2
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    8 / 127 (6.30%)
    7 / 127 (5.51%)
         occurrences all number
    10
    14
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    5 / 127 (3.94%)
    7 / 127 (5.51%)
         occurrences all number
    6
    12
    Abdominal wall disorder
    Additional description: Abdominal wall disorder
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
    Additional description: Aphthous ulcer
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Bowel movement irregularity
    Additional description: Bowel movement irregularity
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Burning mouth syndrome
    Additional description: Burning mouth syndrome
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Chronic gastritis
    Additional description: Chronic gastritis
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    3
    Colitis
    Additional description: Colitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    2
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    4 / 127 (3.15%)
    6 / 127 (4.72%)
         occurrences all number
    6
    6
    Dental caries
    Additional description: Dental caries
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    11 / 127 (8.66%)
    15 / 127 (11.81%)
         occurrences all number
    28
    29
    Diverticulum intestinal
    Additional description: Diverticulum intestinal
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
    Additional description: Dry mouth
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Duodenogastric reflux
    Additional description: Duodenogastric reflux
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    6 / 127 (4.72%)
    2 / 127 (1.57%)
         occurrences all number
    6
    6
    Dysphagia
    Additional description: Dysphagia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Epigastric discomfort
    Additional description: Epigastric discomfort
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Gastric disorder
    Additional description: Gastric disorder
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    2
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    4 / 127 (3.15%)
    1 / 127 (0.79%)
         occurrences all number
    4
    3
    Gastritis erosive
    Additional description: Gastritis erosive
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal angiodysplasia
    Additional description: Gastrointestinal angiodysplasia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorder
    Additional description: Gastrointestinal disorder
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal motility disorder
    Additional description: Gastrointestinal motility disorder
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal pain
    Additional description: Gastrointestinal pain
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Gastrointestinal scarring
    Additional description: Gastrointestinal scarring
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 127 (3.94%)
    1 / 127 (0.79%)
         occurrences all number
    5
    1
    Gastrooesophageal sphincter insufficiency
    Additional description: Gastrooesophageal sphincter insufficiency
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Gingival bleeding
    Additional description: Gingival bleeding
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Gingival hypertrophy
    Additional description: Gingival hypertrophy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Gingival pain
    Additional description: Gingival pain
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Gingival recession
    Additional description: Gingival recession
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Gingivitis ulcerative
    Additional description: Gingivitis ulcerative
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Haematemesis
    Additional description: Haematemesis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
    Additional description: Haematochezia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Haemorrhoidal haemorrhage
    Additional description: Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Haemorrhoids
    Additional description: Haemorrhoids
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    4
    1
    Inguinal hernia
    Additional description: Inguinal hernia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Intra-abdominal haematoma
    Additional description: Intra-abdominal haematoma
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Irritable bowel syndrome
    Additional description: Irritable bowel syndrome
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Mouth swelling
    Additional description: Mouth swelling
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    4 / 127 (3.15%)
    17 / 127 (13.39%)
         occurrences all number
    6
    21
    Oesophagitis
    Additional description: Oesophagitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Pancreatitis chronic
    Additional description: Pancreatitis chronic
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    3
    1
    Paraesthesia oral
    Additional description: Paraesthesia oral
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Rectal fissure
    Additional description: Rectal fissure
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Rectal haemorrhage
    Additional description: Rectal haemorrhage
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Rectal polyp
    Additional description: Rectal polyp
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Reflux gastritis
    Additional description: Reflux gastritis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    2 / 127 (1.57%)
    2 / 127 (1.57%)
         occurrences all number
    2
    5
    Toothache
    Additional description: Toothache
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Truncus coeliacus thrombosis
    Additional description: Truncus coeliacus thrombosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    3 / 127 (2.36%)
    6 / 127 (4.72%)
         occurrences all number
    3
    7
    Skin and subcutaneous tissue disorders
    Acanthosis nigricans
    Additional description: Acanthosis nigricans
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Actinic keratosis
    Additional description: Actinic keratosis
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Alopecia
    Additional description: Alopecia
         subjects affected / exposed
    6 / 127 (4.72%)
    0 / 127 (0.00%)
         occurrences all number
    9
    0
    Blood blister
    Additional description: Blood blister
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Dermal cyst
    Additional description: Dermal cyst
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
    Additional description: Dermatitis
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Dermatitis acneiform
    Additional description: Dermatitis acneiform
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Dry skin
    Additional description: Dry skin
         subjects affected / exposed
    2 / 127 (1.57%)
    5 / 127 (3.94%)
         occurrences all number
    2
    5
    Eczema
    Additional description: Eczema
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    6
    1
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    6 / 127 (4.72%)
    1 / 127 (0.79%)
         occurrences all number
    7
    1
    Erythrosis
    Additional description: Erythrosis
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Haemorrhage subcutaneous
    Additional description: Haemorrhage subcutaneous
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Henoch-Schonlein purpura
    Additional description: Henoch-Schonlein purpura
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Hyperhidrosis
    Additional description: Hyperhidrosis
         subjects affected / exposed
    4 / 127 (3.15%)
    1 / 127 (0.79%)
         occurrences all number
    4
    1
    Hyperkeratosis
    Additional description: Hyperkeratosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Night sweats
    Additional description: Night sweats
         subjects affected / exposed
    2 / 127 (1.57%)
    4 / 127 (3.15%)
         occurrences all number
    2
    4
    Photosensitivity reaction
    Additional description: Photosensitivity reaction
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    10 / 127 (7.87%)
    9 / 127 (7.09%)
         occurrences all number
    75
    11
    Pruritus generalised
    Additional description: Pruritus generalised
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Psoriasis
    Additional description: Psoriasis
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Rash
    Additional description: Rash
         subjects affected / exposed
    3 / 127 (2.36%)
    5 / 127 (3.94%)
         occurrences all number
    3
    7
    Rash erythematous
    Additional description: Rash erythematous
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Rash papular
    Additional description: Rash papular
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Rosacea
    Additional description: Rosacea
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Skin disorder
    Additional description: Skin disorder
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Skin exfoliation
    Additional description: Skin exfoliation
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Skin fissures
    Additional description: Skin fissures
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Skin hyperpigmentation
    Additional description: Skin hyperpigmentation
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Skin swelling
    Additional description: Skin swelling
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Skin ulcer
    Additional description: Skin ulcer
         subjects affected / exposed
    0 / 127 (0.00%)
    7 / 127 (5.51%)
         occurrences all number
    0
    9
    Urticaria
    Additional description: Urticaria
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Xeroderma
    Additional description: Xeroderma
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    4
    0
    Renal and urinary disorders
    Calculus urinary
    Additional description: Calculus urinary
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    7
    1
    Chronic kidney disease
    Additional description: Chronic kidney disease
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Diabetic nephropathy
    Additional description: Diabetic nephropathy
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    2 / 127 (1.57%)
    3 / 127 (2.36%)
         occurrences all number
    2
    3
    Haematuria
    Additional description: Haematuria
         subjects affected / exposed
    1 / 127 (0.79%)
    3 / 127 (2.36%)
         occurrences all number
    2
    3
    Leukocyturia
    Additional description: Leukocyturia
         subjects affected / exposed
    2 / 127 (1.57%)
    3 / 127 (2.36%)
         occurrences all number
    2
    3
    Micturition urgency
    Additional description: Micturition urgency
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Nephrolithiasis
    Additional description: Nephrolithiasis
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Nephropathy
    Additional description: Nephropathy
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Nephropathy toxic
    Additional description: Nephropathy toxic
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Nephroptosis
    Additional description: Nephroptosis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    2
    Nocturia
    Additional description: Nocturia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
    Additional description: Proteinuria
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    3
    Pyelocaliectasis
    Additional description: Pyelocaliectasis
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Renal cyst
    Additional description: Renal cyst
         subjects affected / exposed
    2 / 127 (1.57%)
    7 / 127 (5.51%)
         occurrences all number
    2
    7
    Renal colic
    Additional description: Renal colic
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Tubulointerstitial nephritis
    Additional description: Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Urinary tract disorder
    Additional description: Urinary tract disorder
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Endocrine disorders
    Autoimmune thyroiditis
    Additional description: Autoimmune thyroiditis
         subjects affected / exposed
    4 / 127 (3.15%)
    1 / 127 (0.79%)
         occurrences all number
    4
    1
    Goitre
    Additional description: Goitre
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Hyperthyroidism
    Additional description: Hyperthyroidism
         subjects affected / exposed
    4 / 127 (3.15%)
    0 / 127 (0.00%)
         occurrences all number
    4
    0
    Hypothyroidism
    Additional description: Hypothyroidism
         subjects affected / exposed
    7 / 127 (5.51%)
    2 / 127 (1.57%)
         occurrences all number
    7
    2
    Thyroiditis
    Additional description: Thyroiditis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    18 / 127 (14.17%)
    6 / 127 (4.72%)
         occurrences all number
    39
    10
    Arthritis
    Additional description: Arthritis
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Arthritis reactive
    Additional description: Arthritis reactive
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    13 / 127 (10.24%)
    7 / 127 (5.51%)
         occurrences all number
    18
    10
    Bone pain
    Additional description: Bone pain
         subjects affected / exposed
    3 / 127 (2.36%)
    3 / 127 (2.36%)
         occurrences all number
    3
    3
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Diffuse idiopathic skeletal hyperostosis
    Additional description: Diffuse idiopathic skeletal hyperostosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Gouty arthritis
    Additional description: Gouty arthritis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Groin pain
    Additional description: Groin pain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Haemarthrosis
    Additional description: Haemarthrosis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Joint swelling
    Additional description: Joint swelling
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    3
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    4 / 127 (3.15%)
    3 / 127 (2.36%)
         occurrences all number
    4
    3
    Muscular weakness
    Additional description: Muscular weakness
         subjects affected / exposed
    4 / 127 (3.15%)
    0 / 127 (0.00%)
         occurrences all number
    5
    0
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    8
    1
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    5 / 127 (3.94%)
    0 / 127 (0.00%)
         occurrences all number
    14
    0
    Musculoskeletal stiffness
    Additional description: Musculoskeletal stiffness
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    12 / 127 (9.45%)
    6 / 127 (4.72%)
         occurrences all number
    20
    11
    Neck pain
    Additional description: Neck pain
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    7 / 127 (5.51%)
    2 / 127 (1.57%)
         occurrences all number
    8
    3
    Osteochondrosis
    Additional description: Osteochondrosis
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Osteopenia
    Additional description: Osteopenia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Osteoporosis
    Additional description: Osteoporosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    10 / 127 (7.87%)
    6 / 127 (4.72%)
         occurrences all number
    16
    6
    Rotator cuff syndrome
    Additional description: Rotator cuff syndrome
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Scoliosis
    Additional description: Scoliosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Sjogren's syndrome
    Additional description: Sjogren's syndrome
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Spinal osteoarthritis
    Additional description: Spinal osteoarthritis
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Spinal retrolisthesis
    Additional description: Spinal retrolisthesis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Spinal pain
    Additional description: Spinal pain
         subjects affected / exposed
    4 / 127 (3.15%)
    5 / 127 (3.94%)
         occurrences all number
    4
    5
    Spondylolisthesis
    Additional description: Spondylolisthesis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Temporomandibular joint syndrome
    Additional description: Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Tendonitis
    Additional description: Tendonitis
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Infections and infestations
    Alveolar osteitis
    Additional description: Alveolar osteitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Acute sinusitis
    Additional description: Acute sinusitis
         subjects affected / exposed
    2 / 127 (1.57%)
    2 / 127 (1.57%)
         occurrences all number
    3
    2
    Borrelia infection
    Additional description: Borrelia infection
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    6 / 127 (4.72%)
    12 / 127 (9.45%)
         occurrences all number
    10
    13
    COVID-19
    Additional description: COVID-19
         subjects affected / exposed
    3 / 127 (2.36%)
    3 / 127 (2.36%)
         occurrences all number
    3
    3
    COVID-19 pneumonia
    Additional description: COVID-19 pneumonia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Conjunctivitis
    Additional description: Conjunctivitis
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    3
    2
    Chronic sinusitis
    Additional description: Chronic sinusitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    2 / 127 (1.57%)
    3 / 127 (2.36%)
         occurrences all number
    7
    6
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Erysipelas
    Additional description: Erysipelas
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Folliculitis
    Additional description: Folliculitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    2
    Fungal infection
    Additional description: Fungal infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Fungal skin infection
    Additional description: Fungal skin infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Furuncle
    Additional description: Furuncle
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Gastrointestinal viral infection
    Additional description: Gastrointestinal viral infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    5 / 127 (3.94%)
    2 / 127 (1.57%)
         occurrences all number
    5
    2
    Hordeolum
    Additional description: Hordeolum
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Infected dermal cyst
    Additional description: Infected dermal cyst
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Infection
    Additional description: Infection
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    6 / 127 (4.72%)
    15 / 127 (11.81%)
         occurrences all number
    7
    15
    Laryngitis
    Additional description: Laryngitis
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Lyme disease
    Additional description: Lyme disease
         subjects affected / exposed
    3 / 127 (2.36%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    9 / 127 (7.09%)
    14 / 127 (11.02%)
         occurrences all number
    20
    24
    Oesophageal candidiasis
    Additional description: Oesophageal candidiasis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Onychomycosis
    Additional description: Onychomycosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
    Additional description: Oral candidiasis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Oral fungal infection
    Additional description: Oral fungal infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
    Additional description: Oral herpes
         subjects affected / exposed
    5 / 127 (3.94%)
    3 / 127 (2.36%)
         occurrences all number
    5
    4
    Oral infection
    Additional description: Oral infection
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Otitis externa
    Additional description: Otitis externa
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Parainfluenzae virus infection
    Additional description: Parainfluenzae virus infection
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Paronychia
    Additional description: Paronychia
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Periodontitis
    Additional description: Periodontitis
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Pharyngitis
    Additional description: Pharyngitis
         subjects affected / exposed
    1 / 127 (0.79%)
    3 / 127 (2.36%)
         occurrences all number
    1
    7
    Pharyngotonsillitis
    Additional description: Pharyngotonsillitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    4
    Pulpitis dental
    Additional description: Pulpitis dental
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Pyelonephritis acute
    Additional description: Pyelonephritis acute
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Pyelonephritis chronic
    Additional description: Pyelonephritis chronic
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
    Additional description: Respiratory tract infection
         subjects affected / exposed
    4 / 127 (3.15%)
    4 / 127 (3.15%)
         occurrences all number
    4
    4
    Respiratory tract infection viral
    Additional description: Respiratory tract infection viral
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Rhinitis
    Additional description: Rhinitis
         subjects affected / exposed
    7 / 127 (5.51%)
    3 / 127 (2.36%)
         occurrences all number
    9
    4
    Rhinotracheitis
    Additional description: Rhinotracheitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    2 / 127 (1.57%)
    4 / 127 (3.15%)
         occurrences all number
    2
    5
    Staphylococcal infection
    Additional description: Staphylococcal infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Tinea versicolour
    Additional description: Tinea versicolour
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Tonsillitis
    Additional description: Tonsillitis
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Tooth infection
    Additional description: Tooth infection
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Tracheitis
    Additional description: Tracheitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    8 / 127 (6.30%)
    8 / 127 (6.30%)
         occurrences all number
    17
    11
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    11 / 127 (8.66%)
    7 / 127 (5.51%)
         occurrences all number
    18
    12
    Viraemia
    Additional description: Viraemia
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    6 / 127 (4.72%)
    0 / 127 (0.00%)
         occurrences all number
    6
    0
    Vulvovaginal mycotic infection
    Additional description: Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    3 / 127 (2.36%)
    2 / 127 (1.57%)
         occurrences all number
    3
    3
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Diabetes mellitus
    Additional description: Diabetes mellitus
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Diabetic metabolic decompensation
    Additional description: Diabetic metabolic decompensation
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Dyslipidaemia
    Additional description: Dyslipidaemia
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    Folate deficiency
    Additional description: Folate deficiency
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Gout
    Additional description: Gout
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Hypercalcaemia
    Additional description: Hypercalcaemia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Hyperchloraemia
    Additional description: Hyperchloraemia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 127 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
    Additional description: Hypercholesterolaemia
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    3
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    5 / 127 (3.94%)
    1 / 127 (0.79%)
         occurrences all number
    6
    1
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    1 / 127 (0.79%)
    3 / 127 (2.36%)
         occurrences all number
    2
    5
    Hyperlipidaemia
    Additional description: Hyperlipidaemia
         subjects affected / exposed
    1 / 127 (0.79%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    Hypernatraemia
    Additional description: Hypernatraemia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Hypertriglyceridaemia
    Additional description: Hypertriglyceridaemia
         subjects affected / exposed
    1 / 127 (0.79%)
    4 / 127 (3.15%)
         occurrences all number
    1
    4
    Hyperuricaemia
    Additional description: Hyperuricaemia
         subjects affected / exposed
    4 / 127 (3.15%)
    3 / 127 (2.36%)
         occurrences all number
    6
    4
    Hypoalbuminaemia
    Additional description: Hypoalbuminaemia
         subjects affected / exposed
    3 / 127 (2.36%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    Hypocalcaemia
    Additional description: Hypocalcaemia
         subjects affected / exposed
    5 / 127 (3.94%)
    2 / 127 (1.57%)
         occurrences all number
    10
    6
    Hypoglycaemia
    Additional description: Hypoglycaemia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    2 / 127 (1.57%)
    1 / 127 (0.79%)
         occurrences all number
    4
    2
    Hypomagnesaemia
    Additional description: Hypomagnesaemia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    Hypoproteinaemia
    Additional description: Hypoproteinaemia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Iron deficiency
    Additional description: Iron deficiency
         subjects affected / exposed
    8 / 127 (6.30%)
    4 / 127 (3.15%)
         occurrences all number
    14
    10
    Magnesium deficiency
    Additional description: Magnesium deficiency
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Steroid diabetes
    Additional description: Steroid diabetes
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 127 (0.79%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
    Additional description: Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 127 (0.79%)
         occurrences all number
    1
    1
    Vitamin D deficiency
    Additional description: Vitamin D deficiency
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 127 (0.79%)
         occurrences all number
    3
    1

    More information

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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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32014125
    http://www.ncbi.nlm.nih.gov/pubmed/32814349
    http://www.ncbi.nlm.nih.gov/pubmed/33134869
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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