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    Clinical Trial Results:
    A Placebo-Controlled, Double-Blind, Randomized, Multicenter, Three Arm Phase III Trial to Compare the Efficacy and Safety of Ibrutinib vs. Placebo in Previously Untreated Binet Stage A CLL Patients with Risk of Early Disease Progression

    Summary
    EudraCT number
    		 2013-003211-22
    Trial protocol
    		 DE  
    Global end of trial date
    11 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Aug 2023
    First version publication date
    24 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLL12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02863718
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Board Approval Number: 13-396
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Albertus-Magnus-Platz 1, Cologne, Germany, 50923
    Public contact
    Marie Kronmüller, University Hospital Cologne, Department I of Internal Medicine, Kerpener Strasse 62, 50937 Cologne, 0049 22147888220, cll-studie@uk-kolen.de
    Scientific contact
    Dr. med. Petra Langerbeins, University Hospital Cologne, Department I of Internal Medicine, Kerpener Strasse 62, 50937 Cologne, 0049 22147888220, cll-studie@uk-kolen.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to demonstrate superiority of ibrutinib over placebo in prolonging EFS for subjects with treatment-naïve CLL stage A and intermediate or (very) high risk of disease progression. All subjects with intermediate, (very) high risk randomized to the treatment arm will be treated up to active progressive disease with treatment indication according to iwCLL-Guidelines with the objective to demonstrate prolongation of EFS for the ibrutinib arm. EFS is defined as the time between randomization until active progressive disease with treatment indication according to the iwCLL-Guidelines, initiation of subsequent treatment for CLL, or death.
    Protection of trial subjects
    Safety measures to prevent or to manage known risks associated with CLL, such as infections or cytopenia or known adverse reactions related to ibrutinib, such as bleeding events, cardiac arrhythmias and cardiac failure, hypertension and diarrhea have been included in the protocol. In chapter 2.4 of the protocol the most frequent risks were described, including recommendations how to prevent and manage these potential adverse events . The protocol includes sections (section 8.6.) regarding permitted and prohibited medication respectively, known interactions and precautions with concomitant medication, especially with CYP3A4 inhibitors or inducers. The protocol provides clear guidance for dose modifications and treatment discontinuation.
    Background therapy
    		 Asymptomatic patients with early-stage disease (Rai 0, Binet A), should be monitored without therapy unless they have evidence of rapid disease progression. So far, studies on early-stage disease were unable to show a benefit of early therapeutic interventions.
    Evidence for comparator
    		 To date no proven effective intervention for Binet A patients exists and watchful waiting should remain state of the art, especially, because published data do not support the concern, that a "delayed" (start only, when disease progresses to a treatment requiring disease according to the iwCLL guidelines) treatment would lead to a disadvantage of patients in early stage disease. Hence, the use of placebo as the comparator arm was considered justified.
    Actual start date of recruitment
    05 May 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 8 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 515
    Worldwide total number of subjects
    515
    EEA total number of subjects
    515
    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)
    313
    From 65 to 84 years
    201
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 From 5 May 2014 to 14 February 2019, 648 patients consented to participate in the study and were screened for eligibility, of which 133 patients were excluded. A total of 515 patients were enrolled, 152 low-risk patients were allocated to the observational cohort, 182 and 181 patients were randomly assigned to receive ibrutinib and placebo.

    Pre-assignment
    Screening details
    		 From 133 Screening failures, 73 did not meet eligibility criteria, 50 withdrew consent, 4 did not complete risk stratification and 6 were sreening failures due to administrative reasons.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The randomization procedure was accomplished by a validated interactive web response system (IWRS). Patients were stratified by TP53 mutation status and risk group. Patients, site staff, and the sponsor’s clinical and medical representatives were unaware of treatment group assignments. Ibrutinib and placebo capsules were identical in appearance. The blinding was not broken throughout the study unless it was absolutely considered essential.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ibrutinib
    Arm description
    		 Patients were instructed to take 3 capsules (for a dose of 420 mg Ibrutinib) once daily. One cycle was defined as 28 calendar days. Dose modifications were allowed for the management of adverse events (AEs). Study drug could be paused for a maximum of 28 consecutive days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibrutinib
    Investigational medicinal product code
    SUB120863
    Other name
    EU/1/14/945/001
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Ibrutinib 420mg will be administered daily up to active progressive disease with treatment indication according to iwCLL-Guidelines. A cycle is defined as 28 calendar days. Ibrutinib was administered until active progressive disease with treatment indication according to iwCLL guidelines or unacceptable toxicity was assessed. If a subject showed signs of progression, the subject was allowed to continue study drug treatment until active progressive disease with treatment indication according to the iwCLL Guidelines was observed.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo. A cycle is defined as 28 calendar days. Placebo was continued until active progressive disease with treatment indication according to iwCLL guidelines or unacceptable toxicity was observed. If a subject showed signs of progression, the subject was allowed to continue study drug treatment until active progressive disease with treatment indication according to the iwCLL guidelines was assessed.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match capsules were also provided as a gray, size 0 hard gelatin capsule for oral administration. Subjects were instructed to take 3 capsules (for a dose of 420 mg), orally once daily.

    Arm title
    		 Watch and Wait
    Arm description
    		 Subjects at low risk were not randomized and did not receive treatment but were only followed by watch & wait.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Ibrutinib Placebo Watch and Wait
    Started
    182
    181
    152
    Completed
    64
    33
    152
    Not completed
    118
    148
    0
         Consent withdrawn by subject
    1
    4
    -
         Any study treatment received
    15
    10
    -
         Progressive disease requiring treatment
    4
    66
    -
         Adverse event, non-fatal
    75
    40
    -
         New CLL treatment without progressive disease
    1
    -
    -
         Death
    1
    1
    -
         Non-compliance
    12
    21
    -
         Other reason
    9
    6
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ibrutinib
    Reporting group description
    		 Patients were instructed to take 3 capsules (for a dose of 420 mg Ibrutinib) once daily. One cycle was defined as 28 calendar days. Dose modifications were allowed for the management of adverse events (AEs). Study drug could be paused for a maximum of 28 consecutive days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo. A cycle is defined as 28 calendar days. Placebo was continued until active progressive disease with treatment indication according to iwCLL guidelines or unacceptable toxicity was observed. If a subject showed signs of progression, the subject was allowed to continue study drug treatment until active progressive disease with treatment indication according to the iwCLL guidelines was assessed.

    Reporting group title
    Watch and Wait
    Reporting group description
    		 Subjects at low risk were not randomized and did not receive treatment but were only followed by watch & wait.

    Reporting group values
    		 Ibrutinib Placebo Watch and Wait Total
    Number of subjects
    		 182 181 152 515
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 100 93 120 313
        From 65-84 years
    		 81 88 32 201
        85 years and over
    		 1 0 0 1
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 64 (55 to 70) 64 (55 to 70) 57 (52 to 63) -
    Gender categorical
    Units: Subjects
        Female
    		 45 54 85 184
        Male
    		 137 127 67 331
    GCLLSG Prognostic Index Risk Group
    Units: Subjects
        low
    		 0 0 152 152
        intermediate
    		 137 136 0 273
        high
    		 40 42 0 82
        very high
    		 5 3 0 8
        missing
    		 0 0 0 0
    Binet Stage
    The Binet staging system is one of the two staging systems currently adopted in assessment of chronic lymphocytic leukemia (CLL). It classifies CLL according to the number of involved regions (spleen, liver and the axillary, cervical and inguinal lymph nodes), as well as the presence of anemia or thrombocytopenia.
    Units: Subjects
        Binet A
    		 181 181 152 514
        Binet B
    		 1 0 0 1
        Binet C
    		 0 0 0 0
    Cytogenetic subgroup by hierarchical order
    Döhner et al first published a hierarchical model including five categories for chromosomal abnormalities (deletion 17p, deletion 11q, trisomy 12, no abnormalities according to the Döhner's model, deletion 13q) with prognostic value in CLL, with the shortest survival estimates observed in patients with del(17p), followed by those with del(11q) in the absence of del(17p).
    Units: Subjects
        Deletion 17p
    		 6 7 0 13
        Deletion 11q
    		 21 19 0 40
        Trisomy 12
    		 24 28 4 56
        No abnormalities according to Doehner's model
    		 36 30 27 93
        Deletion 13q
    		 95 97 121 313
    CIRS Score
    The Cumulative Illness Rating Scale (CIRS) is a comprehensive tool to evaluate comorbidities, which has been validated in multiple medical settings and is increasingly used in CLL. 14 organ categories can be scored according to the severeness of potential comorbidities with a score between 0 and 4.
    Units: Score points
        median (inter-quartile range (Q1-Q3))
    		 2 (1.0 to 4.3) 3 (1.0 to 4.0) 2 (0.0 to 3.0) -

    End points

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    End points reporting groups
    Reporting group title
    Ibrutinib
    Reporting group description
    		 Patients were instructed to take 3 capsules (for a dose of 420 mg Ibrutinib) once daily. One cycle was defined as 28 calendar days. Dose modifications were allowed for the management of adverse events (AEs). Study drug could be paused for a maximum of 28 consecutive days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo. A cycle is defined as 28 calendar days. Placebo was continued until active progressive disease with treatment indication according to iwCLL guidelines or unacceptable toxicity was observed. If a subject showed signs of progression, the subject was allowed to continue study drug treatment until active progressive disease with treatment indication according to the iwCLL guidelines was assessed.

    Reporting group title
    Watch and Wait
    Reporting group description
    		 Subjects at low risk were not randomized and did not receive treatment but were only followed by watch & wait.

    Primary: Event-free Survival

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    End point title
    		 Event-free Survival [1]
    End point description
    The analysis of the primary efficacy parameter EFS will be performed on the population of all patients with intermediate, high or very high risk being randomized to receive ibrutinib or placebo using a two-sided stratified log-rank test with risk group as stratification factor (intermediate risk / high risk / very high risk) (at 0.05 significance level; not adjusted). In addition Kaplan-Meier survival methodology will be used to calculate the median EFS and estimated EFS rates for one, two and three years etc. after randomization. The corresponding hazard ratio and 95% confidence interval will be determined using a stratified (by risk group) Cox proportional hazard regression model.
    End point type
    Primary
    End point timeframe
    The primary efficacy parameter is event-free survival (EFS) defined as the time of randomization until symptomatic disease progression with treatment indication, initiation of subsequent treatment for CLL or death by any cause, whichever occurs first.
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The primary objective of the study is to demonstrate superiority of ibrutinib over placebo in prolonging event-free survival in treatment naïve Binet stage A CLL patients with intermediate to (very) high risk of disease progression. Therefore this analysis was based on randomized patients of the two treatment arms with ibrutinib or placebo.
    End point values
    		 Ibrutinib Placebo
    Number of subjects analysed
    182 [2]
    181
    Units: Percentage
    number (not applicable)
        Median EFS (months)
    0
    51.6
        1-year survival
    96.4
    88.9
        2-year survival
    90.9
    74.5
        3-year survival
    87.7
    61.2
        4-year survival
    84.1
    52.2
        5-year survival
    78.2
    48.0
    Notes
    [2] - Median EFS was not reached in this subgroup.
    Statistical analysis title
    		 Stratified log-rank test regarding EFS
    Statistical analysis description
    Treatment comparison for the primary efficacy parameter EFS will be performed using a two-sided stratified log-rank test using the GCLLSG Prognostic Index Risk Group as stratification factor (at 0.05 significance level; not adjusted).
    Comparison groups
    Ibrutinib v Placebo
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 log-rank test
    Confidence interval
    Statistical analysis title
    		 Cox regression regarding EFS
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 95% confidence interval estimated through a stratified (by the GCLLSG Prognostic Index Risk Group) Cox proportional hazard regression model. If the null hypothesis is rejected and the observed HR is favorable for the ibrutinib arm, then it is concluded that early treatment with ibrutinib significantly lowers the risk of EFS events in Binet stage A CLL patients with increased risk of disease progression.
    Comparison groups
    Ibrutinib v Placebo
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.276
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.188
         upper limit
    		 0.407
    Notes
    [3] - In Cox-regression the Placebo-group was used as reference category (Ibrutinib vs. Placebo).

    Secondary: Overall survival

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    End point title
    		 Overall survival [4]
    End point description
    The analysis of the secondary efficacy endpoint OS will be performed on the population of all patients with intermediate, high or very high risk being randomized to receive ibrutinib or placebo using a two-sided stratified log-rank test with risk group as stratification factor (intermediate risk / high risk / very high risk). In addition Kaplan-Meier survival methodology will be used to calculate the median OS and estimated OS rates for one, two and three years etc. after randomization. The corresponding hazard ratio and 95% confidence interval will be determined using a stratified (by risk group) Cox proportional hazard regression model.
    End point type
    Secondary
    End point timeframe
    Overall survival (OS) will be calculated from the date of randomization to the date of death due to any cause. Subjects who have not yet died at the time of analysis will be censored at the date of last observation they were assessed to be alive.
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary objective of the study is to demonstrate superiority of ibrutinib over placebo in treatment naïve Binet stage A CLL patients with intermediate to (very) high risk of disease progression in prolonging overall survival. Therefore this analysis was based on randomized patients of the two treatment arms with ibrutinib or placebo.
    End point values
    		 Ibrutinib Placebo
    Number of subjects analysed
    182 [5]
    181 [6]
    Units: Percentage
    number (not applicable)
        Median OS
    0
    0
        1-year survival
    98.8
    100.0
        2-year survival
    97.6
    100.0
        3-year survival
    97.0
    98.8
        4-year survival
    94.1
    96.0
        5-year survival
    93.3
    93.6
    Notes
    [5] - Median OS was not reached in this subgroup.
    [6] - Median OS was not reached in this subgroup.
    Statistical analysis title
    		 Stratified log-rank test regarding OS
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter OS will be performed using a two-sided stratified log-rank test using the GCLLSG Prognostic Index Risk Group as stratification factor.
    Comparison groups
    Placebo v Ibrutinib
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.562
    Method
    		 log-rank test
    Confidence interval
    Statistical analysis title
    		 Cox regression regarding OS
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 95% confidence interval estimated through a stratified (by the GCLLSG Prognostic Index Risk Group) Cox proportional hazard regression model.
    Comparison groups
    Ibrutinib v Placebo
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.791
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.358
         upper limit
    		 1.748
    Notes
    [7] - In Cox-regression the Placebo-group was used as reference category (Ibrutinib vs. Placebo).

    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
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Ibrutinib
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Ibrutinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    101 / 168 (60.12%)
    102 / 170 (60.00%)
         number of deaths (all causes)
    14
    11
         number of deaths resulting from adverse events
    13
    10
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenal adenoma
    Additional description: Adrenal adenoma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
    Additional description: Breast cancer
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
    Additional description: Benign neoplasm of bladder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    12 / 168 (7.14%)
    4 / 170 (2.35%)
         occurrences causally related to treatment / all
    2 / 18
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
    Additional description: Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
    Additional description: Colon adenoma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
    Additional description: Endometrial cancer
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
    Additional description: Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal papilloma of breast
    Additional description: Intraductal papilloma of breast
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
    Additional description: Lung adenocarcinoma
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung neoplasm malignant
    Additional description: Lung neoplasm malignant
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant melanoma
    Additional description: Malignant melanoma
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
    Additional description: Meningioma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
    Additional description: Myelodysplastic syndrome
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liposarcoma
    Additional description: Liposarcoma
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma of the skin
    Additional description: Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodular melanoma
    Additional description: Nodular melanoma
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
    Additional description: Non-small cell lung cancer
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian adenoma
    Additional description: Ovarian adenoma
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
    Additional description: Ovarian cancer
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal adenocarcinoma
    Additional description: Rectal adenocarcinoma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
    Additional description: Prostate cancer
         subjects affected / exposed
    5 / 168 (2.98%)
    4 / 170 (2.35%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer metastatic
    Additional description: Renal cancer metastatic
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Small cell lung cancer
    Additional description: Small cell lung cancer
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Richter's syndrome
    Additional description: Richter's syndrome
         subjects affected / exposed
    5 / 168 (2.98%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Thyroid cancer
    Additional description: Thyroid cancer
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
    Additional description: Squamous cell carcinoma
         subjects affected / exposed
    4 / 168 (2.38%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
    Additional description: Squamous cell carcinoma of skin
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveal melanoma
    Additional description: Uveal melanoma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
    Additional description: Circulatory collapse
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    1 / 168 (0.60%)
    3 / 170 (1.76%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jugular vein distension
    Additional description: Jugular vein distension
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (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
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
    Additional description: Subdural haemorrhage
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
    Additional description: Venous thrombosis limb
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardiac pacemaker replacement
    Additional description: Cardiac pacemaker replacement
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac resynchronisation therapy
    Additional description: Cardiac resynchronisation therapy
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary arterial stent insertion
    Additional description: Coronary arterial stent insertion
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device removal
    Additional description: Medical device removal
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroprosthesis implantation
    Additional description: Neuroprosthesis implantation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatectomy
    Additional description: Prostatectomy
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (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
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
    Additional description: Death
         subjects affected / exposed
    4 / 168 (2.38%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Hernia
    Additional description: Hernia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Necrosis
    Additional description: Necrosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
    Additional description: Sudden cardiac death
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ulcer
    Additional description: Ulcer
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
    Additional description: Drug hypersensitivity
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
    Additional description: Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic floor muscle weakness
    Additional description: Pelvic floor muscle weakness
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
    Additional description: Vaginal prolapse
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma-chronic obstructive pulmonary disease overlap syndrome
    Additional description: Asthma-chronic obstructive pulmonary disease overlap syndrome
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
    Additional description: Interstitial lung disease
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
    Additional description: Nasal septum deviation
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    3 / 168 (1.79%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sleep apnoea syndrome
    Additional description: Sleep apnoea syndrome
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delusion of parasitosis
    Additional description: Delusion of parasitosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
    Additional description: Depression
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Catheterisation cardiac
    Additional description: Catheterisation cardiac
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical observation
    Additional description: Medical observation
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
    Additional description: Ankle fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
    Additional description: Fractured sacrum
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
    Additional description: Foot fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
    Additional description: Femur fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
    Additional description: Femoral neck fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
    Additional description: Facial bones fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
    Additional description: Humerus fracture
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
    Additional description: Infusion related reaction
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
    Additional description: Joint dislocation
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb fracture
    Additional description: Limb fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
    Additional description: Lumbar vertebral fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
    Additional description: Meniscus injury
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
    Additional description: Multiple fractures
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural nausea
    Additional description: Procedural nausea
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
    Additional description: Radius fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
    Additional description: Rib fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
    Additional description: Road traffic accident
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
    Additional description: Skin laceration
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
    Additional description: Spinal fracture
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
    Additional description: Splenic rupture
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
    Additional description: Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
    Additional description: Subdural haematoma
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Tendon rupture
    Additional description: Tendon rupture
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
    Additional description: Toxicity to various agents
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
    Additional description: Tibia fracture
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaccination complication
    Additional description: Vaccination complication
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    3 / 168 (1.79%)
    11 / 170 (6.47%)
         occurrences causally related to treatment / all
    2 / 4
    9 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
    Additional description: Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
    Additional description: Acute myocardial infarction
         subjects affected / exposed
    5 / 168 (2.98%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
    Additional description: Cardiac arrest
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac aneurysm
    Additional description: Cardiac aneurysm
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
    Additional description: Cardiac disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
    Additional description: Cardiac failure congestive
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic coronary syndrome
    Additional description: Chronic coronary syndrome
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    3 / 168 (1.79%)
    3 / 170 (1.76%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Congestive cardiomyopathy
    Additional description: Congestive cardiomyopathy
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
    Additional description: Coronary artery disease
         subjects affected / exposed
    6 / 168 (3.57%)
    6 / 170 (3.53%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
    Additional description: Coronary artery stenosis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
    Additional description: Mitral valve incompetence
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (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 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia paroxysmal
    Additional description: Tachycardia paroxysmal
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve incompetence
    Additional description: Tricuspid valve incompetence
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
    Additional description: Ventricular tachycardia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Basilar artery thrombosis
    Additional description: Basilar artery thrombosis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia infarction
    Additional description: Basal ganglia infarction
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia haemorrhage
    Additional description: Basal ganglia haemorrhage
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
    Additional description: Cerebellar infarction
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
    Additional description: Cerebral haemorrhage
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
    Additional description: Cerebral ischaemia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
    Additional description: Cerebrovascular accident
         subjects affected / exposed
    3 / 168 (1.79%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
    Additional description: Cervicobrachial syndrome
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
    Additional description: Dementia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness postural
    Additional description: Dizziness postural
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
    Additional description: Epilepsy
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
    Additional description: Embolic stroke
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
    Additional description: Lumbar radiculopathy
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurodegenerative disorder
    Additional description: Neurodegenerative disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
    Additional description: Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior reversible encephalopathy syndrome
    Additional description: Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
    Additional description: Radiculopathy
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
    Additional description: Seizure
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
    Additional description: Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic stroke
    Additional description: Thrombotic stroke
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
    Additional description: Transient ischaemic attack
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
    Additional description: Febrile neutropenia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic anaemia
    Additional description: Haemolytic anaemia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolysis
    Additional description: Haemolysis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
    Additional description: Leukocytosis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic haematoma
    Additional description: Splenic haematoma
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Meniere's disease
    Additional description: Meniere's disease
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
    Additional description: Glaucoma
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery occlusion
    Additional description: Retinal artery occlusion
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal degeneration
    Additional description: Retinal degeneration
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
    Additional description: Retinal haemorrhage
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
    Additional description: Colitis ischaemic
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal inflammation
    Additional description: Gastrointestinal inflammation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
    Additional description: Hiatus hernia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (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
    2 / 168 (1.19%)
    3 / 170 (1.76%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal stenosis
    Additional description: Large intestinal stenosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
    Additional description: Large intestine perforation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
    Additional description: Umbilical hernia
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
    Additional description: Bile duct stone
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
    Additional description: Cholecystitis acute
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
    Additional description: Cholestasis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatotoxicity
    Additional description: Hepatotoxicity
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
    Additional description: Hepatic failure
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
    Additional description: Rash
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
    Additional description: Skin ulcer
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    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
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
    Additional description: Calculus urinary
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
    Additional description: Nephrolithiasis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postrenal failure
    Additional description: Postrenal failure
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal infarct
    Additional description: Renal infarct
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
    Additional description: Renal colic
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
    Additional description: Ureteric stenosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
    Additional description: Ureterolithiasis
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
    Additional description: Urethral stenosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
    Additional description: Goitre
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid haemorrhage
    Additional description: Thyroid haemorrhage
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
    Additional description: Intervertebral disc disorder
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (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
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mandibular mass
    Additional description: Mandibular mass
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    1 / 168 (0.60%)
    3 / 170 (1.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondritis
    Additional description: Osteochondritis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
    Additional description: Periarthritis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
    Additional description: Rotator cuff syndrome
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
    Additional description: Spondylolisthesis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
    Additional description: Synovial cyst
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
    Additional description: Spinal stenosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis perforated
    Additional description: Appendicitis perforated
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
    Additional description: Abscess limb
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
    Additional description: Abscess
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial prostatitis
    Additional description: Bacterial prostatitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
    Additional description: Carbuncle
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis infective
    Additional description: Bursitis infective
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
    Additional description: Clostridium difficile colitis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium colitis
    Additional description: Clostridium colitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dacryocystitis
    Additional description: Dacryocystitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
    Additional description: Device related infection
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (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
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
    Additional description: COVID-19
         subjects affected / exposed
    7 / 168 (4.17%)
    7 / 170 (4.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
    Additional description: COVID-19 pneumonia
         subjects affected / exposed
    1 / 168 (0.60%)
    3 / 170 (1.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis escherichia
    Additional description: Cystitis escherichia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
    Additional description: Cytomegalovirus infection
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    3 / 168 (1.79%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
    Additional description: Febrile infection
         subjects affected / exposed
    4 / 168 (2.38%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
    Additional description: Escherichia sepsis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Erysipelas
    Additional description: Erysipelas
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
    Additional description: Epididymitis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic pneumonia
    Additional description: Embolic pneumonia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster meningoencephalitis
    Additional description: Herpes zoster meningoencephalitis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst infection
    Additional description: Hepatic cyst infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter gastritis
    Additional description: Helicobacter gastritis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis E
    Additional description: Hepatitis E
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
    Additional description: Infected dermal cyst
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
    Additional description: Infection
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection site abscess
    Additional description: Injection site abscess
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
    Additional description: Intervertebral discitis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphangitis
    Additional description: Lymphangitis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
    Additional description: Mastoiditis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic infection
    Additional description: Neutropenic infection
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
    Additional description: Neutropenic sepsis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
    Additional description: Oesophageal candidiasis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
    Additional description: Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral herpes
    Additional description: Oral herpes
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
    Additional description: Orchitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
    Additional description: Osteomyelitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
    Additional description: Paronychia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis infective
    Additional description: Pericarditis infective
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    11 / 168 (6.55%)
    8 / 170 (4.71%)
         occurrences causally related to treatment / all
    3 / 12
    7 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Salmonellosis
    Additional description: Salmonellosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         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 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
    Additional description: Staphylococcal sepsis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
    Additional description: Urosepsis
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
    Additional description: Tonsillitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis viral
    Additional description: Tracheobronchitis viral
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperphosphataemia
    Additional description: Hyperphosphataemia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
    Additional description: Tumour lysis syndrome
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
    Additional description: Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         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
    		 Placebo Ibrutinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    164 / 168 (97.62%)
    164 / 170 (96.47%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenoma benign
    Additional description: Adenoma benign
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Angiolipoma
    Additional description: Angiolipoma
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Bowen's disease
    Additional description: Bowen's disease
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Cancer fatigue
    Additional description: Cancer fatigue
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Colon adenoma
    Additional description: Colon adenoma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Fibroma
    Additional description: Fibroma
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Haemangioma of liver
    Additional description: Haemangioma of liver
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Kidney angiomyolipoma
    Additional description: Kidney angiomyolipoma
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Lipoma
    Additional description: Lipoma
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Melanocytic naevus
    Additional description: Melanocytic naevus
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    2
    2
    Seborrhoeic keratosis
    Additional description: Seborrhoeic keratosis
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Skin papilloma
    Additional description: Skin papilloma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Sweat gland tumour
    Additional description: Sweat gland tumour
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Vascular disorders
    Aortic aneurysm
    Additional description: Aortic aneurysm
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Arteriosclerosis
    Additional description: Arteriosclerosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Circulatory collapse
    Additional description: Circulatory collapse
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Flushing
    Additional description: Flushing
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    3
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    9 / 168 (5.36%)
    28 / 170 (16.47%)
         occurrences all number
    11
    40
    Hot flush
    Additional description: Hot flush
         subjects affected / exposed
    3 / 168 (1.79%)
    2 / 170 (1.18%)
         occurrences all number
    4
    2
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    12 / 168 (7.14%)
    28 / 170 (16.47%)
         occurrences all number
    12
    31
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    3
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Additional description: Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Orthostatic hypotension
    Additional description: Orthostatic hypotension
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Peripheral vascular disorder
    Additional description: Peripheral vascular disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Thrombophlebitis
    Additional description: Thrombophlebitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Thrombosis
    Additional description: Thrombosis
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Varicophlebitis
    Additional description: Varicophlebitis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Varicose vein
    Additional description: Varicose vein
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Surgical and medical procedures
    Bunion operation
    Additional description: Bunion operation
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Carpal tunnel decompression
    Additional description: Carpal tunnel decompression
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Dental implantation
    Additional description: Dental implantation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Dental operation
    Additional description: Dental operation
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    2
    1
    Dental prosthesis placement
    Additional description: Dental prosthesis placement
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Foot operation
    Additional description: Foot operation
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Hernia repair
    Additional description: Hernia repair
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Jaw operation
    Additional description: Jaw operation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Inguinal hernia repair
    Additional description: Inguinal hernia repair
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Lipoma excision
    Additional description: Lipoma excision
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Renal stone removal
    Additional description: Renal stone removal
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Tooth extraction
    Additional description: Tooth extraction
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Axillary pain
    Additional description: Axillary pain
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    2
    1
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    7 / 168 (4.17%)
    4 / 170 (2.35%)
         occurrences all number
    8
    4
    Chills
    Additional description: Chills
         subjects affected / exposed
    2 / 168 (1.19%)
    3 / 170 (1.76%)
         occurrences all number
    2
    3
    Discomfort
    Additional description: Discomfort
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    35 / 168 (20.83%)
    47 / 170 (27.65%)
         occurrences all number
    39
    61
    Extravasation
    Additional description: Extravasation
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Gait disturbance
    Additional description: Gait disturbance
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    5 / 168 (2.98%)
    0 / 170 (0.00%)
         occurrences all number
    5
    0
    General symptom
    Additional description: General symptom
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Ill-defined disorder
    Additional description: Ill-defined disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Impaired healing
    Additional description: Impaired healing
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Inflammation
    Additional description: Inflammation
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    4
    Influenza like illness
    Additional description: Influenza like illness
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    4
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    2 / 168 (1.19%)
    5 / 170 (2.94%)
         occurrences all number
    2
    5
    Oedema
    Additional description: Oedema
         subjects affected / exposed
    1 / 168 (0.60%)
    4 / 170 (2.35%)
         occurrences all number
    1
    4
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    3 / 168 (1.79%)
    12 / 170 (7.06%)
         occurrences all number
    3
    14
    Performance status decreased
    Additional description: Performance status decreased
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Pain
    Additional description: Pain
         subjects affected / exposed
    1 / 168 (0.60%)
    4 / 170 (2.35%)
         occurrences all number
    2
    6
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    0 / 168 (0.00%)
    5 / 170 (2.94%)
         occurrences all number
    0
    6
    Polyp
    Additional description: Polyp
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    3 / 168 (1.79%)
    7 / 170 (4.12%)
         occurrences all number
    3
    8
    Sensation of foreign body
    Additional description: Sensation of foreign body
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Swelling
    Additional description: Swelling
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Swelling face
    Additional description: Swelling face
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Temperature intolerance
    Additional description: Temperature intolerance
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Ulcer
    Additional description: Ulcer
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Vaccination site reaction
    Additional description: Vaccination site reaction
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy to arthropod bite
    Additional description: Allergy to arthropod bite
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Autoimmune disorder
    Additional description: Autoimmune disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Immunisation reaction
    Additional description: Immunisation reaction
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Seasonal allergy
    Additional description: Seasonal allergy
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    4
    Reproductive system and breast disorders
    Balanoposthitis
    Additional description: Balanoposthitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Benign prostatic hyperplasia
    Additional description: Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 168 (0.60%)
    6 / 170 (3.53%)
         occurrences all number
    1
    6
    Breast cyst
    Additional description: Breast cyst
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Breast pain
    Additional description: Breast pain
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Endometrial hyperplasia
    Additional description: Endometrial hyperplasia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Erectile dysfunction
    Additional description: Erectile dysfunction
         subjects affected / exposed
    1 / 168 (0.60%)
    3 / 170 (1.76%)
         occurrences all number
    1
    3
    Genital pain
    Additional description: Genital pain
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Gynaecomastia
    Additional description: Gynaecomastia
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Menopausal symptoms
    Additional description: Menopausal symptoms
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Metrorrhagia
    Additional description: Metrorrhagia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Orchitis noninfective
    Additional description: Orchitis noninfective
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Postmenopausal haemorrhage
    Additional description: Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Rectocele
    Additional description: Rectocele
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Prostatitis
    Additional description: Prostatitis
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Scrotal pain
    Additional description: Scrotal pain
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Testicular pain
    Additional description: Testicular pain
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Vulvovaginal pain
    Additional description: Vulvovaginal pain
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Uterine polyp
    Additional description: Uterine polyp
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Allergic cough
    Additional description: Allergic cough
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Bronchitis chronic
    Additional description: Bronchitis chronic
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Bronchostenosis
    Additional description: Bronchostenosis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Chronic obstructive pulmonary disease
    Additional description: Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Cough
    Additional description: Cough
         subjects affected / exposed
    13 / 168 (7.74%)
    14 / 170 (8.24%)
         occurrences all number
    17
    18
    Emphysema
    Additional description: Emphysema
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Dysphonia
    Additional description: Dysphonia
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    9 / 168 (5.36%)
    10 / 170 (5.88%)
         occurrences all number
    10
    11
    Dyspnoea exertional
    Additional description: Dyspnoea exertional
         subjects affected / exposed
    7 / 168 (4.17%)
    4 / 170 (2.35%)
         occurrences all number
    7
    5
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    4 / 168 (2.38%)
    21 / 170 (12.35%)
         occurrences all number
    4
    29
    Haemoptysis
    Additional description: Haemoptysis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    2
    1
    Increased bronchial secretion
    Additional description: Increased bronchial secretion
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Laryngeal haemorrhage
    Additional description: Laryngeal haemorrhage
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Lung hypoinflation
    Additional description: Lung hypoinflation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Nasal septum deviation
    Additional description: Nasal septum deviation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Oropharyngeal discomfort
    Additional description: Oropharyngeal discomfort
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    7 / 168 (4.17%)
    5 / 170 (2.94%)
         occurrences all number
    9
    7
    Pharyngeal oedema
    Additional description: Pharyngeal oedema
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Pulmonary pain
    Additional description: Pulmonary pain
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Rhinitis allergic
    Additional description: Rhinitis allergic
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    3
    2
    Rhinorrhoea
    Additional description: Rhinorrhoea
         subjects affected / exposed
    1 / 168 (0.60%)
    4 / 170 (2.35%)
         occurrences all number
    1
    4
    Sleep apnoea syndrome
    Additional description: Sleep apnoea syndrome
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Throat clearing
    Additional description: Throat clearing
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Tonsillar hypertrophy
    Additional description: Tonsillar hypertrophy
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Agitation
    Additional description: Agitation
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Aggression
    Additional description: Aggression
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Anxiety disorder
    Additional description: Anxiety disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Aversion
    Additional description: Aversion
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Depressed mood
    Additional description: Depressed mood
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Confusional state
    Additional description: Confusional state
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Depression
    Additional description: Depression
         subjects affected / exposed
    4 / 168 (2.38%)
    3 / 170 (1.76%)
         occurrences all number
    4
    3
    Initial insomnia
    Additional description: Initial insomnia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    5 / 168 (2.98%)
    5 / 170 (2.94%)
         occurrences all number
    6
    5
    Libido decreased
    Additional description: Libido decreased
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Listless
    Additional description: Listless
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Mood altered
    Additional description: Mood altered
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Nervousness
    Additional description: Nervousness
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Panic attack
    Additional description: Panic attack
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Psychotic disorder
    Additional description: Psychotic disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Restlessness
    Additional description: Restlessness
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Sleep disorder
    Additional description: Sleep disorder
         subjects affected / exposed
    1 / 168 (0.60%)
    10 / 170 (5.88%)
         occurrences all number
    1
    12
    Investigations
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
         subjects affected / exposed
    1 / 168 (0.60%)
    3 / 170 (1.76%)
         occurrences all number
    1
    6
    Arthroscopy
    Additional description: Arthroscopy
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
    Additional description: Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 168 (0.60%)
    3 / 170 (1.76%)
         occurrences all number
    1
    4
    Biopsy prostate
    Additional description: Biopsy prostate
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Blood alkaline phosphatase increased
    Additional description: Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 168 (1.79%)
    0 / 170 (0.00%)
         occurrences all number
    3
    0
    Blood bilirubin increased
    Additional description: Blood bilirubin increased
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    6
    Blood cholesterol increased
    Additional description: Blood cholesterol increased
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Blood creatine phosphokinase increased
    Additional description: Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    2 / 168 (1.19%)
    3 / 170 (1.76%)
         occurrences all number
    2
    3
    Blood glucose increased
    Additional description: Blood glucose increased
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Blood immunoglobulin G decreased
    Additional description: Blood immunoglobulin G decreased
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Blood lactate dehydrogenase increased
    Additional description: Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Blood potassium decreased
    Additional description: Blood potassium decreased
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Blood thyroid stimulating hormone increased
    Additional description: Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Blood uric acid increased
    Additional description: Blood uric acid increased
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Cardiac murmur
    Additional description: Cardiac murmur
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Blood urea increased
    Additional description: Blood urea increased
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    3
    Electrocardiogram repolarisation abnormality
    Additional description: Electrocardiogram repolarisation abnormality
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Electrocardiogram ST segment depression
    Additional description: Electrocardiogram ST segment depression
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
    Additional description: Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 168 (1.79%)
    3 / 170 (1.76%)
         occurrences all number
    3
    4
    Hepatic enzyme increased
    Additional description: Hepatic enzyme increased
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Heart rate irregular
    Additional description: Heart rate irregular
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Immunoglobulins decreased
    Additional description: Immunoglobulins decreased
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Lipase increased
    Additional description: Lipase increased
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Prostatic specific antigen increased
    Additional description: Prostatic specific antigen increased
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Smear cervix
    Additional description: Smear cervix
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
    Additional description: Transaminases increased
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    4
    Urine uric acid increased
    Additional description: Urine uric acid increased
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Weight increased
    Additional description: Weight increased
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    3 / 168 (1.79%)
    4 / 170 (2.35%)
         occurrences all number
    4
    4
    Injury, poisoning and procedural complications
    Acetabulum fracture
    Additional description: Acetabulum fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Accident at work
    Additional description: Accident at work
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Animal scratch
    Additional description: Animal scratch
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Ankle fracture
    Additional description: Ankle fracture
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Arthropod bite
    Additional description: Arthropod bite
         subjects affected / exposed
    2 / 168 (1.19%)
    4 / 170 (2.35%)
         occurrences all number
    2
    7
    Arthropod sting
    Additional description: Arthropod sting
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Bone contusion
    Additional description: Bone contusion
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Burn oral cavity
    Additional description: Burn oral cavity
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Cartilage injury
    Additional description: Cartilage injury
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Concussion
    Additional description: Concussion
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Contusion
    Additional description: Contusion
         subjects affected / exposed
    2 / 168 (1.19%)
    8 / 170 (4.71%)
         occurrences all number
    2
    10
    Fall
    Additional description: Fall
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences all number
    2
    2
    Foot fracture
    Additional description: Foot fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Fracture
    Additional description: Fracture
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hand fracture
    Additional description: Hand fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Ilium fracture
    Additional description: Ilium fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Joint injury
    Additional description: Joint injury
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Infusion related reaction
    Additional description: Infusion related reaction
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Injury corneal
    Additional description: Injury corneal
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Laceration
    Additional description: Laceration
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Ligament rupture
    Additional description: Ligament rupture
         subjects affected / exposed
    0 / 168 (0.00%)
    4 / 170 (2.35%)
         occurrences all number
    0
    4
    Ligament sprain
    Additional description: Ligament sprain
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Limb injury
    Additional description: Limb injury
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Lumbar vertebral fracture
    Additional description: Lumbar vertebral fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Muscle rupture
    Additional description: Muscle rupture
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Meniscus injury
    Additional description: Meniscus injury
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences all number
    2
    2
    Muscle strain
    Additional description: Muscle strain
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Nail avulsion
    Additional description: Nail avulsion
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Patella fracture
    Additional description: Patella fracture
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Post-traumatic pain
    Additional description: Post-traumatic pain
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Skin laceration
    Additional description: Skin laceration
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Spinal compression fracture
    Additional description: Spinal compression fracture
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Spinal fracture
    Additional description: Spinal fracture
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Skin abrasion
    Additional description: Skin abrasion
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Sunburn
    Additional description: Sunburn
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Traumatic fracture
    Additional description: Traumatic fracture
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Traumatic haematoma
    Additional description: Traumatic haematoma
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    3
    Wound complication
    Additional description: Wound complication
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Wound
    Additional description: Wound
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Congenital, familial and genetic disorders
    Atrial septal defect
    Additional description: Atrial septal defect
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Factor V Leiden mutation
    Additional description: Factor V Leiden mutation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hereditary motor and sensory neuropathy
    Additional description: Hereditary motor and sensory neuropathy
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hydrocele
    Additional description: Hydrocele
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Phimosis
    Additional description: Phimosis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Acute myocardial infarction
    Additional description: Acute myocardial infarction
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Angina pectoris
    Additional description: Angina pectoris
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    2
    1
    Aortic valve incompetence
    Additional description: Aortic valve incompetence
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Arrhythmia
    Additional description: Arrhythmia
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Arteriosclerosis coronary artery
    Additional description: Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    2 / 168 (1.19%)
    16 / 170 (9.41%)
         occurrences all number
    9
    16
    Atrioventricular block first degree
    Additional description: Atrioventricular block first degree
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Cardiovascular disorder
    Additional description: Cardiovascular disorder
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    6
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Cardiomegaly
    Additional description: Cardiomegaly
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Coronary artery disease
    Additional description: Coronary artery disease
         subjects affected / exposed
    3 / 168 (1.79%)
    1 / 170 (0.59%)
         occurrences all number
    3
    1
    Coronary artery stenosis
    Additional description: Coronary artery stenosis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Extrasystoles
    Additional description: Extrasystoles
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Hypertensive heart disease
    Additional description: Hypertensive heart disease
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Left ventricular hypertrophy
    Additional description: Left ventricular hypertrophy
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Mitral valve incompetence
    Additional description: Mitral valve incompetence
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    5 / 168 (2.98%)
    3 / 170 (1.76%)
         occurrences all number
    6
    4
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Sinus tachycardia
    Additional description: Sinus tachycardia
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Sinus bradycardia
    Additional description: Sinus bradycardia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Tachyarrhythmia
    Additional description: Tachyarrhythmia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Tachycardia
    Additional description: Tachycardia
         subjects affected / exposed
    4 / 168 (2.38%)
    5 / 170 (2.94%)
         occurrences all number
    4
    5
    Tricuspid valve incompetence
    Additional description: Tricuspid valve incompetence
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Ventricular extrasystoles
    Additional description: Ventricular extrasystoles
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    2
    1
    Nervous system disorders
    Ageusia
    Additional description: Ageusia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Balance disorder
    Additional description: Balance disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Basilar migraine
    Additional description: Basilar migraine
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Cognitive disorder
    Additional description: Cognitive disorder
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Carotid artery stenosis
    Additional description: Carotid artery stenosis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Carpal tunnel syndrome
    Additional description: Carpal tunnel syndrome
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Cervical syndrome
    Additional description: Cervical syndrome
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Cervicobrachial syndrome
    Additional description: Cervicobrachial syndrome
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Convulsion
    Additional description: Convulsion
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Dementia
    Additional description: Dementia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    11 / 168 (6.55%)
    26 / 170 (15.29%)
         occurrences all number
    13
    41
    Diabetic neuropathy
    Additional description: Diabetic neuropathy
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Disturbance in attention
    Additional description: Disturbance in attention
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    3
    Dysaesthesia
    Additional description: Dysaesthesia
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Dysgeusia
    Additional description: Dysgeusia
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Headache
    Additional description: Headache
         subjects affected / exposed
    20 / 168 (11.90%)
    30 / 170 (17.65%)
         occurrences all number
    39
    48
    Hypertonia
    Additional description: Hypertonia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hypoaesthesia
    Additional description: Hypoaesthesia
         subjects affected / exposed
    1 / 168 (0.60%)
    4 / 170 (2.35%)
         occurrences all number
    1
    4
    Hypoaesthesia oral
    Additional description: Hypoaesthesia oral
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Intercostal neuralgia
    Additional description: Intercostal neuralgia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Loss of consciousness
    Additional description: Loss of consciousness
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Muscle spasticity
    Additional description: Muscle spasticity
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Memory impairment
    Additional description: Memory impairment
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Migraine
    Additional description: Migraine
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    3
    1
    Neuralgia
    Additional description: Neuralgia
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Neuropathy peripheral
    Additional description: Neuropathy peripheral
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    1 / 168 (0.60%)
    8 / 170 (4.71%)
         occurrences all number
    1
    12
    Paraparesis
    Additional description: Paraparesis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Parkinson's disease
    Additional description: Parkinson's disease
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Parosmia
    Additional description: Parosmia
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Polyneuropathy
    Additional description: Polyneuropathy
         subjects affected / exposed
    2 / 168 (1.19%)
    6 / 170 (3.53%)
         occurrences all number
    2
    6
    Radiculopathy
    Additional description: Radiculopathy
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Tremor
    Additional description: Tremor
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Vascular encephalopathy
    Additional description: Vascular encephalopathy
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    4 / 168 (2.38%)
    4 / 170 (2.35%)
         occurrences all number
    4
    4
    Coagulopathy
    Additional description: Coagulopathy
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Eosinophilia
    Additional description: Eosinophilia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Haemorrhagic diathesis
    Additional description: Haemorrhagic diathesis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Immune thrombocytopenia
    Additional description: Immune thrombocytopenia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Iron deficiency anaemia
    Additional description: Iron deficiency anaemia
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Leukocytosis
    Additional description: Leukocytosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Lymph node pain
    Additional description: Lymph node pain
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
    Additional description: Lymphadenopathy
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    3
    Splenomegaly
    Additional description: Splenomegaly
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    3 / 168 (1.79%)
    5 / 170 (2.94%)
         occurrences all number
    4
    5
    Ear and labyrinth disorders
    Ear disorder
    Additional description: Ear disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Ear discomfort
    Additional description: Ear discomfort
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Ear pruritus
    Additional description: Ear pruritus
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Ear swelling
    Additional description: Ear swelling
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Ear haemorrhage
    Additional description: Ear haemorrhage
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Hyperacusis
    Additional description: Hyperacusis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Sudden hearing loss
    Additional description: Sudden hearing loss
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Tinnitus
    Additional description: Tinnitus
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    2
    1
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    8 / 168 (4.76%)
    12 / 170 (7.06%)
         occurrences all number
    8
    17
    Vertigo positional
    Additional description: Vertigo positional
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Eye disorders
    Blepharitis
    Additional description: Blepharitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Blepharospasm
    Additional description: Blepharospasm
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Blindness
    Additional description: Blindness
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Cataract
    Additional description: Cataract
         subjects affected / exposed
    2 / 168 (1.19%)
    6 / 170 (3.53%)
         occurrences all number
    2
    6
    Conjunctival haemorrhage
    Additional description: Conjunctival haemorrhage
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    2
    1
    Dacryostenosis acquired
    Additional description: Dacryostenosis acquired
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Diplopia
    Additional description: Diplopia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Dry eye
    Additional description: Dry eye
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Eye haematoma
    Additional description: Eye haematoma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Eye inflammation
    Additional description: Eye inflammation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Eye pruritus
    Additional description: Eye pruritus
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Glaucoma
    Additional description: Glaucoma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Macular degeneration
    Additional description: Macular degeneration
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Macular oedema
    Additional description: Macular oedema
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Posterior capsule opacification
    Additional description: Posterior capsule opacification
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Vision blurred
    Additional description: Vision blurred
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Visual acuity reduced
    Additional description: Visual acuity reduced
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Visual impairment
    Additional description: Visual impairment
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Abdominal pain lower
    Additional description: Abdominal pain lower
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    11 / 168 (6.55%)
    6 / 170 (3.53%)
         occurrences all number
    12
    8
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences all number
    2
    2
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences all number
    2
    2
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    13 / 168 (7.74%)
    11 / 170 (6.47%)
         occurrences all number
    14
    12
    Angular cheilitis
    Additional description: Angular cheilitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Anal inflammation
    Additional description: Anal inflammation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Anal fistula
    Additional description: Anal fistula
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Aphthous ulcer
    Additional description: Aphthous ulcer
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    3
    Ascites
    Additional description: Ascites
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Cheilitis
    Additional description: Cheilitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Chronic gastritis
    Additional description: Chronic gastritis
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    6 / 168 (3.57%)
    9 / 170 (5.29%)
         occurrences all number
    9
    9
    Dental caries
    Additional description: Dental caries
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    31 / 168 (18.45%)
    58 / 170 (34.12%)
         occurrences all number
    48
    101
    Diarrhoea haemorrhagic
    Additional description: Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Diverticulum
    Additional description: Diverticulum
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Diverticulum intestinal
    Additional description: Diverticulum intestinal
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Dry mouth
    Additional description: Dry mouth
         subjects affected / exposed
    6 / 168 (3.57%)
    14 / 170 (8.24%)
         occurrences all number
    7
    15
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    6 / 168 (3.57%)
    27 / 170 (15.88%)
         occurrences all number
    7
    66
    Dysphagia
    Additional description: Dysphagia
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Epigastric discomfort
    Additional description: Epigastric discomfort
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Eructation
    Additional description: Eructation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Gastric disorder
    Additional description: Gastric disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    3 / 168 (1.79%)
    4 / 170 (2.35%)
         occurrences all number
    3
    5
    Frequent bowel movements
    Additional description: Frequent bowel movements
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Glossodynia
    Additional description: Glossodynia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    0 / 168 (0.00%)
    7 / 170 (4.12%)
         occurrences all number
    0
    7
    Gastrointestinal disorder
    Additional description: Gastrointestinal disorder
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Gastrointestinal pain
    Additional description: Gastrointestinal pain
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 168 (1.19%)
    7 / 170 (4.12%)
         occurrences all number
    2
    7
    Gingival bleeding
    Additional description: Gingival bleeding
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    3
    Gingival disorder
    Additional description: Gingival disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Gingival swelling
    Additional description: Gingival swelling
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Gingivitis ulcerative
    Additional description: Gingivitis ulcerative
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Glossitis
    Additional description: Glossitis
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    7
    Gastric ulcer
    Additional description: Gastric ulcer
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
    Additional description: Haematochezia
         subjects affected / exposed
    1 / 168 (0.60%)
    3 / 170 (1.76%)
         occurrences all number
    1
    3
    Haemorrhoids
    Additional description: Haemorrhoids
         subjects affected / exposed
    4 / 168 (2.38%)
    2 / 170 (1.18%)
         occurrences all number
    5
    2
    Haemorrhoids thrombosed
    Additional description: Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hiatus hernia
    Additional description: Hiatus hernia
         subjects affected / exposed
    3 / 168 (1.79%)
    2 / 170 (1.18%)
         occurrences all number
    3
    2
    Intestinal polyp
    Additional description: Intestinal polyp
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Large intestine polyp
    Additional description: Large intestine polyp
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Lip blister
    Additional description: Lip blister
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Loose tooth
    Additional description: Loose tooth
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Mouth swelling
    Additional description: Mouth swelling
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Mouth ulceration
    Additional description: Mouth ulceration
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    4
    Melaena
    Additional description: Melaena
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    2
    1
    Mouth haemorrhage
    Additional description: Mouth haemorrhage
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    3
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    20 / 168 (11.90%)
    32 / 170 (18.82%)
         occurrences all number
    30
    57
    Noninfective gingivitis
    Additional description: Noninfective gingivitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Obstruction gastric
    Additional description: Obstruction gastric
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Oesophageal pain
    Additional description: Oesophageal pain
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Oesophagitis
    Additional description: Oesophagitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Oral disorder
    Additional description: Oral disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Oral pain
    Additional description: Oral pain
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Pancreatic cyst
    Additional description: Pancreatic cyst
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Paraesthesia oral
    Additional description: Paraesthesia oral
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Proctitis
    Additional description: Proctitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Rectal prolapse
    Additional description: Rectal prolapse
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Salivary gland enlargement
    Additional description: Salivary gland enlargement
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    2 / 168 (1.19%)
    13 / 170 (7.65%)
         occurrences all number
    2
    20
    Subileus
    Additional description: Subileus
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Tongue blistering
    Additional description: Tongue blistering
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Tongue ulceration
    Additional description: Tongue ulceration
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Toothache
    Additional description: Toothache
         subjects affected / exposed
    3 / 168 (1.79%)
    3 / 170 (1.76%)
         occurrences all number
    3
    4
    Umbilical hernia
    Additional description: Umbilical hernia
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    7 / 168 (4.17%)
    13 / 170 (7.65%)
         occurrences all number
    9
    16
    Hepatobiliary disorders
    Cholecystitis acute
    Additional description: Cholecystitis acute
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Hepatic cyst
    Additional description: Hepatic cyst
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hepatic steatosis
    Additional description: Hepatic steatosis
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Hyperbilirubinaemia
    Additional description: Hyperbilirubinaemia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Actinic keratosis
    Additional description: Actinic keratosis
         subjects affected / exposed
    4 / 168 (2.38%)
    2 / 170 (1.18%)
         occurrences all number
    4
    4
    Alopecia areata
    Additional description: Alopecia areata
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Alopecia
    Additional description: Alopecia
         subjects affected / exposed
    4 / 168 (2.38%)
    5 / 170 (2.94%)
         occurrences all number
    4
    5
    Asteatosis
    Additional description: Asteatosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Blood blister
    Additional description: Blood blister
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Butterfly rash
    Additional description: Butterfly rash
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Dandruff
    Additional description: Dandruff
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Dermatitis
    Additional description: Dermatitis
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    3
    Dermatitis acneiform
    Additional description: Dermatitis acneiform
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    5
    Dermatitis allergic
    Additional description: Dermatitis allergic
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Dermatitis atopic
    Additional description: Dermatitis atopic
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Dermatitis bullous
    Additional description: Dermatitis bullous
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Dermatosis
    Additional description: Dermatosis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Dermal cyst
    Additional description: Dermal cyst
         subjects affected / exposed
    1 / 168 (0.60%)
    3 / 170 (1.76%)
         occurrences all number
    1
    3
    Ecchymosis
    Additional description: Ecchymosis
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    3
    Eczema
    Additional description: Eczema
         subjects affected / exposed
    1 / 168 (0.60%)
    7 / 170 (4.12%)
         occurrences all number
    1
    9
    Drug eruption
    Additional description: Drug eruption
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Dry skin
    Additional description: Dry skin
         subjects affected / exposed
    5 / 168 (2.98%)
    16 / 170 (9.41%)
         occurrences all number
    5
    19
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    1 / 168 (0.60%)
    3 / 170 (1.76%)
         occurrences all number
    1
    3
    Haemorrhage subcutaneous
    Additional description: Haemorrhage subcutaneous
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hair colour changes
    Additional description: Hair colour changes
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hair growth abnormal
    Additional description: Hair growth abnormal
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hyperhidrosis
    Additional description: Hyperhidrosis
         subjects affected / exposed
    7 / 168 (4.17%)
    4 / 170 (2.35%)
         occurrences all number
    10
    4
    Hyperkeratosis
    Additional description: Hyperkeratosis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Ingrowing nail
    Additional description: Ingrowing nail
         subjects affected / exposed
    0 / 168 (0.00%)
    5 / 170 (2.94%)
         occurrences all number
    0
    5
    Nail atrophy
    Additional description: Nail atrophy
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Nail bed inflammation
    Additional description: Nail bed inflammation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Nail disorder
    Additional description: Nail disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Nail dystrophy
    Additional description: Nail dystrophy
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Nail ridging
    Additional description: Nail ridging
         subjects affected / exposed
    0 / 168 (0.00%)
    4 / 170 (2.35%)
         occurrences all number
    0
    4
    Night sweats
    Additional description: Night sweats
         subjects affected / exposed
    9 / 168 (5.36%)
    5 / 170 (2.94%)
         occurrences all number
    14
    7
    Onychoclasis
    Additional description: Onychoclasis
         subjects affected / exposed
    3 / 168 (1.79%)
    19 / 170 (11.18%)
         occurrences all number
    3
    19
    Onycholysis
    Additional description: Onycholysis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Pain of skin
    Additional description: Pain of skin
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Petechiae
    Additional description: Petechiae
         subjects affected / exposed
    0 / 168 (0.00%)
    7 / 170 (4.12%)
         occurrences all number
    0
    9
    Photosensitivity reaction
    Additional description: Photosensitivity reaction
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Polymorphic light eruption
    Additional description: Polymorphic light eruption
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    6 / 168 (3.57%)
    13 / 170 (7.65%)
         occurrences all number
    7
    15
    Psoriasis
    Additional description: Psoriasis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Purpura
    Additional description: Purpura
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Rash
    Additional description: Rash
         subjects affected / exposed
    10 / 168 (5.95%)
    33 / 170 (19.41%)
         occurrences all number
    15
    44
    Rash erythematous
    Additional description: Rash erythematous
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Rash maculo-papular
    Additional description: Rash maculo-papular
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    9
    Rash papular
    Additional description: Rash papular
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Scalp disorder
    Additional description: Scalp disorder
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic dermatitis
    Additional description: Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Skin discolouration
    Additional description: Skin discolouration
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Skin disorder
    Additional description: Skin disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Skin erosion
    Additional description: Skin erosion
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Skin fissures
    Additional description: Skin fissures
         subjects affected / exposed
    0 / 168 (0.00%)
    8 / 170 (4.71%)
         occurrences all number
    0
    10
    Skin haemorrhage
    Additional description: Skin haemorrhage
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Skin hyperpigmentation
    Additional description: Skin hyperpigmentation
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Skin induration
    Additional description: Skin induration
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Skin irritation
    Additional description: Skin irritation
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Skin lesion
    Additional description: Skin lesion
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Skin sensitisation
    Additional description: Skin sensitisation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Skin ulcer
    Additional description: Skin ulcer
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Swelling face
    Additional description: Swelling face
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Urticaria
    Additional description: Urticaria
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Chromaturia
    Additional description: Chromaturia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Cystitis noninfective
    Additional description: Cystitis noninfective
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences all number
    2
    3
    Haematuria
    Additional description: Haematuria
         subjects affected / exposed
    3 / 168 (1.79%)
    6 / 170 (3.53%)
         occurrences all number
    4
    9
    Incontinence
    Additional description: Incontinence
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Micturition urgency
    Additional description: Micturition urgency
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Nocturia
    Additional description: Nocturia
         subjects affected / exposed
    3 / 168 (1.79%)
    1 / 170 (0.59%)
         occurrences all number
    3
    1
    Pollakiuria
    Additional description: Pollakiuria
         subjects affected / exposed
    6 / 168 (3.57%)
    0 / 170 (0.00%)
         occurrences all number
    6
    0
    Renal cyst
    Additional description: Renal cyst
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    2 / 168 (1.19%)
    3 / 170 (1.76%)
         occurrences all number
    2
    3
    Renal pain
    Additional description: Renal pain
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Endocrine disorders
    Goitre
    Additional description: Goitre
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Hashimoto's disease
    Additional description: Hashimoto's disease
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Hyperparathyroidism
    Additional description: Hyperparathyroidism
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hyperparathyroidism secondary
    Additional description: Hyperparathyroidism secondary
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hypogonadism
    Additional description: Hypogonadism
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
    Additional description: Hypothyroidism
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Thyroid calcification
    Additional description: Thyroid calcification
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Thyroid mass
    Additional description: Thyroid mass
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
    Additional description: Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    15 / 168 (8.93%)
    30 / 170 (17.65%)
         occurrences all number
    18
    37
    Arthritis
    Additional description: Arthritis
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Arthritis reactive
    Additional description: Arthritis reactive
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Arthropathy
    Additional description: Arthropathy
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    20 / 168 (11.90%)
    20 / 170 (11.76%)
         occurrences all number
    24
    24
    Barrel chest
    Additional description: Barrel chest
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Bone pain
    Additional description: Bone pain
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences all number
    2
    2
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences all number
    2
    2
    Collagen disorder
    Additional description: Collagen disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Exostosis
    Additional description: Exostosis
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Flank pain
    Additional description: Flank pain
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences all number
    2
    2
    Foot deformity
    Additional description: Foot deformity
         subjects affected / exposed
    3 / 168 (1.79%)
    1 / 170 (0.59%)
         occurrences all number
    3
    1
    Groin pain
    Additional description: Groin pain
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Hypercreatinaemia
    Additional description: Hypercreatinaemia
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    2
    1
    Joint effusion
    Additional description: Joint effusion
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Joint swelling
    Additional description: Joint swelling
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Intervertebral disc disorder
    Additional description: Intervertebral disc disorder
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    2 / 168 (1.19%)
    3 / 170 (1.76%)
         occurrences all number
    2
    3
    Jaw cyst
    Additional description: Jaw cyst
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Limb discomfort
    Additional description: Limb discomfort
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Muscle atrophy
    Additional description: Muscle atrophy
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    6 / 168 (3.57%)
    25 / 170 (14.71%)
         occurrences all number
    9
    52
    Muscle twitching
    Additional description: Muscle twitching
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Muscular weakness
    Additional description: Muscular weakness
         subjects affected / exposed
    2 / 168 (1.19%)
    3 / 170 (1.76%)
         occurrences all number
    3
    3
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Musculoskeletal disorder
    Additional description: Musculoskeletal disorder
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    5 / 168 (2.98%)
    4 / 170 (2.35%)
         occurrences all number
    6
    5
    Musculoskeletal stiffness
    Additional description: Musculoskeletal stiffness
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    8 / 168 (4.76%)
    12 / 170 (7.06%)
         occurrences all number
    9
    12
    Myositis
    Additional description: Myositis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Neck pain
    Additional description: Neck pain
         subjects affected / exposed
    4 / 168 (2.38%)
    2 / 170 (1.18%)
         occurrences all number
    4
    2
    Muscle tightness
    Additional description: Muscle tightness
         subjects affected / exposed
    1 / 168 (0.60%)
    3 / 170 (1.76%)
         occurrences all number
    1
    3
    Osteoporosis
    Additional description: Osteoporosis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    15 / 168 (8.93%)
    15 / 170 (8.82%)
         occurrences all number
    17
    21
    Pain in jaw
    Additional description: Pain in jaw
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    11 / 168 (6.55%)
    3 / 170 (1.76%)
         occurrences all number
    11
    4
    Periarthritis
    Additional description: Periarthritis
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Periostitis
    Additional description: Periostitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Plantar fasciitis
    Additional description: Plantar fasciitis
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Plica syndrome
    Additional description: Plica syndrome
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Rheumatic disorder
    Additional description: Rheumatic disorder
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
    Additional description: Spinal osteoarthritis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Spinal pain
    Additional description: Spinal pain
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Spinal stenosis
    Additional description: Spinal stenosis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Synovial cyst
    Additional description: Synovial cyst
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Tendon discomfort
    Additional description: Tendon discomfort
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Tendonitis
    Additional description: Tendonitis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Tenosynovitis
    Additional description: Tenosynovitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Torticollis
    Additional description: Torticollis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Infections and infestations
    Acne pustular
    Additional description: Acne pustular
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Abscess limb
    Additional description: Abscess limb
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    3
    Abscess
    Additional description: Abscess
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Angular cheilitis
    Additional description: Angular cheilitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Alveolar osteitis
    Additional description: Alveolar osteitis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Bacterial diarrhoea
    Additional description: Bacterial diarrhoea
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Arthritis infective
    Additional description: Arthritis infective
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Atypical pneumonia
    Additional description: Atypical pneumonia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Bacterial rhinitis
    Additional description: Bacterial rhinitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Bacterial vaginosis
    Additional description: Bacterial vaginosis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Bacterial food poisoning
    Additional description: Bacterial food poisoning
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Bacterial infection
    Additional description: Bacterial infection
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Bacterial pyelonephritis
    Additional description: Bacterial pyelonephritis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    19 / 168 (11.31%)
    26 / 170 (15.29%)
         occurrences all number
    21
    30
    Bronchitis bacterial
    Additional description: Bronchitis bacterial
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Bronchitis viral
    Additional description: Bronchitis viral
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Bursitis infective
    Additional description: Bursitis infective
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Campylobacter infection
    Additional description: Campylobacter infection
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Candida infection
    Additional description: Candida infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Chronic tonsillitis
    Additional description: Chronic tonsillitis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Chronic sinusitis
    Additional description: Chronic sinusitis
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Conjunctivitis
    Additional description: Conjunctivitis
         subjects affected / exposed
    3 / 168 (1.79%)
    6 / 170 (3.53%)
         occurrences all number
    3
    9
    COVID-19
    Additional description: COVID-19
         subjects affected / exposed
    7 / 168 (4.17%)
    7 / 170 (4.12%)
         occurrences all number
    7
    7
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    12 / 168 (7.14%)
    10 / 170 (5.88%)
         occurrences all number
    20
    21
    Cystitis bacterial
    Additional description: Cystitis bacterial
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Dermatitis infected
    Additional description: Dermatitis infected
         subjects affected / exposed
    3 / 168 (1.79%)
    0 / 170 (0.00%)
         occurrences all number
    3
    0
    Diarrhoea infectious
    Additional description: Diarrhoea infectious
         subjects affected / exposed
    2 / 168 (1.19%)
    3 / 170 (1.76%)
         occurrences all number
    2
    3
    Diverticulitis
    Additional description: Diverticulitis
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    4
    1
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Epididymitis
    Additional description: Epididymitis
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    6
    Erysipelas
    Additional description: Erysipelas
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Eye infection
    Additional description: Eye infection
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Eyelid infection
    Additional description: Eyelid infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Enterococcal infection
    Additional description: Enterococcal infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Febrile infection
    Additional description: Febrile infection
         subjects affected / exposed
    3 / 168 (1.79%)
    1 / 170 (0.59%)
         occurrences all number
    3
    1
    Folliculitis
    Additional description: Folliculitis
         subjects affected / exposed
    2 / 168 (1.19%)
    3 / 170 (1.76%)
         occurrences all number
    2
    3
    Fungal infection
    Additional description: Fungal infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Fungal pharyngitis
    Additional description: Fungal pharyngitis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Fungal skin infection
    Additional description: Fungal skin infection
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Gastric infection
    Additional description: Gastric infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    5 / 168 (2.98%)
    5 / 170 (2.94%)
         occurrences all number
    6
    7
    Gastroenteritis norovirus
    Additional description: Gastroenteritis norovirus
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Gastroenteritis viral
    Additional description: Gastroenteritis viral
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Gastrointestinal candidiasis
    Additional description: Gastrointestinal candidiasis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Gastrointestinal infection
    Additional description: Gastrointestinal infection
         subjects affected / exposed
    13 / 168 (7.74%)
    15 / 170 (8.82%)
         occurrences all number
    14
    26
    Genital herpes
    Additional description: Genital herpes
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Genital herpes zoster
    Additional description: Genital herpes zoster
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Gingivitis
    Additional description: Gingivitis
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences all number
    2
    2
    Haemophilus infection
    Additional description: Haemophilus infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Helicobacter gastritis
    Additional description: Helicobacter gastritis
         subjects affected / exposed
    2 / 168 (1.19%)
    2 / 170 (1.18%)
         occurrences all number
    2
    2
    Hepatitis E
    Additional description: Hepatitis E
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Herpes simplex
    Additional description: Herpes simplex
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    3
    0
    Herpes virus infection
    Additional description: Herpes virus infection
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    10 / 168 (5.95%)
    5 / 170 (2.94%)
         occurrences all number
    13
    5
    Hepatitis viral
    Additional description: Hepatitis viral
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Impetigo
    Additional description: Impetigo
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Infected bite
    Additional description: Infected bite
         subjects affected / exposed
    3 / 168 (1.79%)
    0 / 170 (0.00%)
         occurrences all number
    3
    0
    Infected bites
    Additional description: Infected bites
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Infected cyst
    Additional description: Infected cyst
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Infection
    Additional description: Infection
         subjects affected / exposed
    12 / 168 (7.14%)
    9 / 170 (5.29%)
         occurrences all number
    13
    14
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    8 / 168 (4.76%)
    12 / 170 (7.06%)
         occurrences all number
    13
    22
    Injection site abscess
    Additional description: Injection site abscess
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Laryngitis
    Additional description: Laryngitis
         subjects affected / exposed
    0 / 168 (0.00%)
    4 / 170 (2.35%)
         occurrences all number
    0
    4
    Lip infection
    Additional description: Lip infection
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    4
    Localised infection
    Additional description: Localised infection
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Lyme disease
    Additional description: Lyme disease
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Mucosal infection
    Additional description: Mucosal infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    2
    Nail bed infection
    Additional description: Nail bed infection
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Nail infection
    Additional description: Nail infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Nasal herpes
    Additional description: Nasal herpes
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    72 / 168 (42.86%)
    51 / 170 (30.00%)
         occurrences all number
    126
    108
    Neutropenic infection
    Additional description: Neutropenic infection
         subjects affected / exposed
    2 / 168 (1.19%)
    0 / 170 (0.00%)
         occurrences all number
    2
    0
    Nosocomial infection
    Additional description: Nosocomial infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Onychomycosis
    Additional description: Onychomycosis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Oral fungal infection
    Additional description: Oral fungal infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Oral herpes
    Additional description: Oral herpes
         subjects affected / exposed
    12 / 168 (7.14%)
    2 / 170 (1.18%)
         occurrences all number
    18
    6
    Oral infection
    Additional description: Oral infection
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Oral viral infection
    Additional description: Oral viral infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Orchitis
    Additional description: Orchitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Otitis externa
    Additional description: Otitis externa
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Paronychia
    Additional description: Paronychia
         subjects affected / exposed
    1 / 168 (0.60%)
    10 / 170 (5.88%)
         occurrences all number
    3
    12
    Parotitis
    Additional description: Parotitis
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    3
    1
    Penile infection
    Additional description: Penile infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Periodontitis
    Additional description: Periodontitis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
    Additional description: Pharyngitis
         subjects affected / exposed
    4 / 168 (2.38%)
    4 / 170 (2.35%)
         occurrences all number
    4
    4
    Phlebitis infective
    Additional description: Phlebitis infective
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    7 / 168 (4.17%)
    10 / 170 (5.88%)
         occurrences all number
    9
    15
    Postoperative wound infection
    Additional description: Postoperative wound infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Pseudomonas infection
    Additional description: Pseudomonas infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Purulence
    Additional description: Purulence
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Pyelonephritis
    Additional description: Pyelonephritis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Pyoderma
    Additional description: Pyoderma
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Rash pustular
    Additional description: Rash pustular
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    3
    Respiratory tract infection
    Additional description: Respiratory tract infection
         subjects affected / exposed
    8 / 168 (4.76%)
    13 / 170 (7.65%)
         occurrences all number
    9
    23
    Retinitis
    Additional description: Retinitis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
    Additional description: Rhinitis
         subjects affected / exposed
    3 / 168 (1.79%)
    10 / 170 (5.88%)
         occurrences all number
    5
    10
    Root canal infection
    Additional description: Root canal infection
         subjects affected / exposed
    1 / 168 (0.60%)
    2 / 170 (1.18%)
         occurrences all number
    1
    2
    Scarlet fever
    Additional description: Scarlet fever
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Scrotal infection
    Additional description: Scrotal infection
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    5
    Seminal vesicular infection
    Additional description: Seminal vesicular infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Sialoadenitis
    Additional description: Sialoadenitis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Sinobronchitis
    Additional description: Sinobronchitis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    8 / 168 (4.76%)
    9 / 170 (5.29%)
         occurrences all number
    11
    15
    Sinusitis bacterial
    Additional description: Sinusitis bacterial
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Skin infection
    Additional description: Skin infection
         subjects affected / exposed
    1 / 168 (0.60%)
    4 / 170 (2.35%)
         occurrences all number
    2
    5
    Subcutaneous abscess
    Additional description: Subcutaneous abscess
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Tinea infection
    Additional description: Tinea infection
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Tinea versicolour
    Additional description: Tinea versicolour
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    17 / 168 (10.12%)
    19 / 170 (11.18%)
         occurrences all number
    20
    30
    Tongue fungal infection
    Additional description: Tongue fungal infection
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
    Additional description: Tonsillitis
         subjects affected / exposed
    3 / 168 (1.79%)
    3 / 170 (1.76%)
         occurrences all number
    3
    5
    Tooth abscess
    Additional description: Tooth abscess
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Tooth infection
    Additional description: Tooth infection
         subjects affected / exposed
    4 / 168 (2.38%)
    3 / 170 (1.76%)
         occurrences all number
    4
    3
    Tracheitis
    Additional description: Tracheitis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Trichomoniasis
    Additional description: Trichomoniasis
         subjects affected / exposed
    1 / 168 (0.60%)
    0 / 170 (0.00%)
         occurrences all number
    1
    0
    Tinea pedis
    Additional description: Tinea pedis
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    12 / 168 (7.14%)
    20 / 170 (11.76%)
         occurrences all number
    14
    41
    Vulvovaginal mycotic infection
    Additional description: Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Viral diarrhoea
    Additional description: Viral diarrhoea
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    5 / 168 (2.98%)
    3 / 170 (1.76%)
         occurrences all number
    5
    3
    Viral upper respiratory tract infection
    Additional description: Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 168 (1.19%)
    1 / 170 (0.59%)
         occurrences all number
    2
    1
    Wound infection bacterial
    Additional description: Wound infection bacterial
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Wound infection
    Additional description: Wound infection
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Wound infection pseudomonas
    Additional description: Wound infection pseudomonas
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    3 / 168 (1.79%)
    3 / 170 (1.76%)
         occurrences all number
    5
    3
    Diabetes mellitus
    Additional description: Diabetes mellitus
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Diabetic metabolic decompensation
    Additional description: Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Folate deficiency
    Additional description: Folate deficiency
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Gout
    Additional description: Gout
         subjects affected / exposed
    1 / 168 (0.60%)
    6 / 170 (3.53%)
         occurrences all number
    2
    6
    Hypercholesterolaemia
    Additional description: Hypercholesterolaemia
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    3
    Hypercreatininaemia
    Additional description: Hypercreatininaemia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Hyperlipasaemia
    Additional description: Hyperlipasaemia
         subjects affected / exposed
    1 / 168 (0.60%)
    1 / 170 (0.59%)
         occurrences all number
    1
    1
    Hyperuricaemia
    Additional description: Hyperuricaemia
         subjects affected / exposed
    0 / 168 (0.00%)
    3 / 170 (1.76%)
         occurrences all number
    0
    3
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Iron deficiency
    Additional description: Iron deficiency
         subjects affected / exposed
    1 / 168 (0.60%)
    4 / 170 (2.35%)
         occurrences all number
    1
    4
    Protein deficiency
    Additional description: Protein deficiency
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
    Additional description: Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 168 (0.00%)
    2 / 170 (1.18%)
         occurrences all number
    0
    2
    Vitamin B12 deficiency
    Additional description: Vitamin B12 deficiency
         subjects affected / exposed
    0 / 168 (0.00%)
    1 / 170 (0.59%)
         occurrences all number
    0
    1
    Vitamin D deficiency
    Additional description: Vitamin D deficiency
         subjects affected / exposed
    3 / 168 (1.79%)
    4 / 170 (2.35%)
         occurrences all number
    3
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Oct 2014
    New Information on Ibrutinib and update of protocol and PIC following IB V8.0
    04 Feb 2015
    Adaption of sample size calculation with respect to current recruitment rate
    15 Jul 2015
    Changes in the protocol, following DSMB recommendation to prohibit concomitant medication with Xa-Inhibitors, alternatively to allow heparines only.
    13 Jan 2016
    New Information on Ibrutinib and update of protocol and PIC following IB V9.0;Adaption of statistical assumption to allow confirmatory analyses of overall survival
    08 Jul 2016
    New safety information on interstitial lung disease, amendment of PIC accordingly
    28 Mar 2017
    New Information on Ibrutinib and update of protocol and PIC following IB V10.0
    26 Jun 2017
    New Information on Ibrutinib and update of protocol and PIC following SmPC Februar 2017; administrative changes
    09 Apr 2018
    New Information on Ibrutinib and update of protocol and PIC following SmPC August 2017; Adaption of analysis time points and details of statistical analyses

    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/34758069
    For support, Contact us.
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