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    Clinical Trial Results:
    A phase 3 multicenter, randomized, prospective, open-label trial of standard chemoimmunotherapy (FCR/BR) versus rituximab plus venetoclax (RVe) versus obinutuzumab (GA101) plus venetoclax (GVe) versus obinutuzumab plus ibrutinib plus venetoclax (GIVe) in fit patients with previously untreated chronic lymphocytic leukemia (CLL) without del(17p) or TP53 mutation.

    Summary
    EudraCT number
    		 2015-004936-36
    Trial protocol
    		 SE   DK   DE   AT   FI   BE   IE  
    Global end of trial date
    29 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Mar 2025
    First version publication date
    12 Mar 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CLL13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02950051
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor`s number: UNI-KOELN-2751
    Sponsors
    Sponsor organisation name
    UNIVERSITY OF COLOGNE
    Sponsor organisation address
    ALBERTUS-MAGNUS-PLATZ, Cologne, Germany, 50923
    Public contact
    Dr. med. Anna Fink, German CLL Study Group, COLOGNE UNIVERSITY HOSPITAL, KERPENER STR. 62, 50924 COLOGNE, GERMANY, +49 22147888220, anna-maria.fink@uk-koeln.de
    Scientific contact
    PROF. DR. MED. BARBARA EICHHORST, German CLL Study Group, COLOGNE UNIVERSITY HOSPITAL, KERPENER STR. 62, 50924 COLOGNE, GERMANY, +49 22147888220, barbara.eichhorst@uk-koeln.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
    29 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of obinutuzumab (GA101) plus venetoclax (GVe) versus standard chemoimmunotherapy (BR/FCR) [concerning MRD negativity measured by flow cytometry in peripheral blood (PB) at month 15] and obinutuzumab plus ibrutinib plus venetoclax (GIVe) versus standard chemoimmunotherapy (BR/FCR) [concerning progression free survival (PFS)] in previously untreated, fit CLL patients without del(17p) or TP53 mutation.
    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 any of the IMPs have been included in the protocol. Chapter 8 of the protocol included sections how to prevent and manage known side effects, including detailed instruction about premedication, modifications and treatment discontinuation. The protocol includes sections with prohibited, permitted and medication used with caution for each study medication, especially for known interactions with CYP3A4 inhibitors or inducers.
    Background therapy
    		 For a long time, chemoimmunotherapy with fludarabine, cyclophsophamid and rituximab (FCR) for patients ≤ 65 or bendamustine plus rituximab for patients > 65 years, was considered standard first-line treatment for patients with CLL. Since several novel targeted agents such as the Btk-inhibitor ibrutinib (formerly PCI-32765), the PI3K-inhibitor CAL-101 (idelalisib) and the Bcl2-antagonist venetoclax (ABT-199, GDC-0199) have become available, the treatment landscape for CLL as faced profound changes. These new targeted agents were tested in phase-II and III-studies and showed a favorable toxicity profile and a promising efficacy with a potentially synergistic mechanism of action. The PI3K-inhibitor Idealisib has been approved for treatment of relapsed CLL as well as frontline therapy of CLL with TP53 mut/del. The combination of venetoclax and CD20-antibodies is approved for firstline therapy (obinutuzumab) as well as in relapsed disease (rituximab). Btk-inhibitors are approved as monotherapy in firstline treatment and relapsed disease or in combination with venetoclax or CD-20 antibodies for first line therapy. The addition of the Btk-inhibitor ibrutinib to the venetoclax plus CD20-anitbody based combination, is expected to add significant activity by targeting a third mechanism order to drive CLL cells into apoptosis. The aim of the CLL13 trial is to evaluate, wether the standard chemoimmunotherapy in the frontline treatment of physically fit patients in CLL can be replaced by combinations of venetoclax (and ibrutinib) with anti-CD20-antibodies, which may induce extremely long lasting remissions.
    Evidence for comparator
    		 Chemoimmunotherapy is the standard of care in first-line treatment of CLL. In patients < 65years, the combination of fludarabine, cyclophsophamid and rituximab is considered standard treatment, while patients >65 years usually receive bendamustine plus rituximab. However, these conventional chemoimmunotherapies are associated with side effects caused by the rather unspecific mode of action of the chemotherapy. Therefore, there is a need for alternative, chemotherapy-free regimes. Published data support that targeted agents may show a promising response rate while having a favorable safety profile with lower rates of toxicity. All agents used in this trial have been approved in firstline treatment or in relapsed disease, as monotherapy or as combination therapy for patients with CLL.
    Actual start date of recruitment
    13 Dec 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Switzerland: 82
    Country: Number of subjects enrolled
    Netherlands: 185
    Country: Number of subjects enrolled
    Sweden: 53
    Country: Number of subjects enrolled
    Austria: 36
    Country: Number of subjects enrolled
    Belgium: 31
    Country: Number of subjects enrolled
    Denmark: 113
    Country: Number of subjects enrolled
    Finland: 21
    Country: Number of subjects enrolled
    Germany: 333
    Country: Number of subjects enrolled
    Ireland: 38
    Country: Number of subjects enrolled
    Israel: 34
    Worldwide total number of subjects
    926
    EEA total number of subjects
    810
    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)
    564
    From 65 to 84 years
    362
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between Dec 13, 2016, and Oct 13, 2019, 1080 patients were screened for eligibility. 926 were enrolled, 154 excluded. 229 were assigned to receive chemoimmunotherapy (150 FCR, 79 BR), 237 were assigned to receive venetoclax+rituxumab, 229 were assigned to venetoclax+obinutuzumab and 231 were allocated to venetoclax+obinutuzumab+ibrutinib.

    Pre-assignment
    Screening details
    		 From 154 screening failures, 136 did not meet eligibility criteria, 4 were not included due to physician´s decision and 14 due to patient´s decision.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard chemoimmunotherapy (SCIT)
    Arm description
    		 The SCIT treatment consists of 6 cycles, each with a precise duration of 28 days. Patients ≤ 65 years will receive 6 cycles of fludarabine, cyclophosphamide and rituximab (FCR). Patients > 65 years will receive 6 cycles of bendamusine and rituximab (BR).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will receive fludarabine on days 1-3 of cycle 1-6. Cycle 1-6 Day 1 fludarabine 25mg/m² i.v., day 2 fludarabine 25mg/m² i.v. day 3 fludarabine 25mg/m² i.v.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will receive cyclophsophamide on days 1-3 of cycle 1-6. Cycle 1-6 Day 1 cyclophosphamide 250mg/m² i.v., day 2 cyclophosphamide 250mg/m² i.v. day 3 cyclophosphamide 250mg/m² i.v.

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will receive rituximab (MabThera®) intravenously before the application of chemotherapy with premedication according to clinical practice of the participating sites. Cycle 1: 375 mg/ m² i.v. Cycles 2-6: 500 mg/ m² i.v

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will receive rituximab (MabThera®) intravenously before the application of Bendamustine with premedication according to clinical practice of the participating sites. Cycle 1: 375 mg/ m² i.v. Cycle 2-6: 500 mg/ m² i.v.

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate and solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will receive bendamustine on day 1 and 2 of cycle 1-6. Cycle 1-6 Day 1 bendamustine 90mg/m² i.v., day 2 bendamustine 90mg/m² i.v.

    Arm title
    		 Venetoclax, rituximab (RVe)
    Arm description
    		 The RVe treatment consists of 12 cycles, each with a precise duration of 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will receive rituximab (MabThera®) intravenously: Cycle 1: Day 1: 375 mg/ m² i.v. Cycle 2-6: Day 1: 500 mg/ m² i.v.

    Investigational medicinal product name
    Venetoclax
    Investigational medicinal product code
    ABT 199
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will receive the first dosage of venetoclax on day 22 of cycle 1. The daily intake of venetoclax starts with a weekly dose ramp-up to final dose Venetoclax p.o.: Cycle 1: Days 22-28: venetoclax 20 mg (2 tabl. at 10 mg) Cycle 2: Days 1-7: venetoclax 50 mg (1 tabl. at 50 mg) Days 8-14: venetoclax 100 mg (1 tabl. at 100 mg) Days 15-21: venetoclax 200 mg (2 tabl. at 100 mg) Days 22-28: venetoclax 400 mg (4 tabl. at 100 mg) Cycles 3-12: Days 1-28: venetoclax 400 mg (4 tabl. at 100 mg) Due to the risk of adverse events, especially tumor-lysis-syndromes (TLS), the dose of venetoclax will be increased slowly every week until the final dose of 400 mg is reached (ramp-up). In order to diagnose a TLS at an early stage certain safety measures as specified in the study protocol must be followed. On days with administration of both, venetoclax and rituximab, oral intake of venetoclax will be followed by intravenous administration of rituximab.

    Arm title
    		 Venetoclax, obinutuzumab (GVe)
    Arm description
    		 The GVe treatment consists of 12 cycles, each with a precise duration of 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Venetoclax
    Investigational medicinal product code
    ABT 199
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will receive the first dosage of venetoclax on day 22 of cycle 1. The daily intake of venetoclax starts with a weekly dose ramp-up to final dose Venetoclax p.o.: Cycle 1: Days 22-28: venetoclax 20 mg (2 tabl. at 10 mg) Cycle 2: Days 1-7: venetoclax 50 mg (1 tabl. at 50 mg) Days 8-14: venetoclax 100 mg (1 tabl. at 100 mg) Days 15-21: venetoclax 200 mg (2 tabl. at 100 mg) Days 22-28: venetoclax 400 mg (4 tabl. at 100 mg) Cycles 3-12: Days 1-28: venetoclax 400 mg (4 tabl. at 100 mg) Due to the risk of adverse events, especially tumor-lysis-syndromes (TLS), the dose of venetoclax will be increased slowly every week until the final dose of 400 mg is reached (ramp-up). In order to diagnose a TLS at an early stage certain safety measures as specified in the study protocol must be followed. On days with administration of both, venetoclax and obinutzumab, oral intake of venetoclax will be followed by intravenous administration of obinutuzumab.

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    GA 101
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will receive obinutuzumab infusions on days 1 (and 2), 8 and 15 during the first cycle, as well as on day 1 of cycles 2-6. Obinutuzumab i.v. infusion: Cycle 1: Day 1: obinutuzumab 100 mg Day 1 (or 2): obinutuzumab 900 mg Day 8: obinutuzumab 1000 mg Day 15: obinutuzumab 1000 mg Cycles 2-6: Day 1: obinutuzumab1000 mg The first infusion of obinutuzumab may be administered at the full dose (1000 mg) on day 1 of the first cycle if the infusion of a test-dosage of 100 mg is well tolerated by the patient. Alternatively, if the first 100mg infusion on day 1 is not tolerated well, the remaining 900 mg of the first dose should be administered on day 2.

    Arm title
    		 Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Arm description
    		 The GIVe treatment consists of 12 cycles (ibrutinib might be given up to 36 cycles), each with a precise duration of 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Venetoclax
    Investigational medicinal product code
    ABT 199
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will receive the first dosage of venetoclax on day 22 of cycle 1. The daily intake of venetoclax starts with a weekly dose ramp-up to final dose. Venetoclax p.o.: Cycle 1: Days 22-28: 20 mg (2 tabl. at 10 mg) Cycle 2: Days 1-7: 50 mg (1 tabl. at 50 mg) Days 8-14: 100 mg (1 tabl. at 100 mg) Days 15-21: 200 mg (2 tabl. at 100 mg) Days 22-28: 400 mg (4 tabl. at 100 mg) Cycles 3-12: Days 1-28: 400 mg (4 tabl. at 100 mg) Due to the risk of adverse events, especially tumor-lysis-syndromes (TLS), the dose of venetoclax will be increased slowly every week until the final dose of 400 mg is reached (ramp-up). In order to diagnose a TLS at an early stage certain safety measures as specified in the study protocol must be followed.On days with administration of more than one study drug, oral intake of ibrutinib (before breakfast) will be followed by oral intake of venetoclax (during breakfast), at least iv administration of obinutuzumab will take place if applicable.

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    GA 101
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will receive obinutuzumab infusions on days 1 (and 2), 8 and 15 during the first cycle, as well as on day 1 of cycles 2-6. obinutuzumab i.v. infusion: Cycle 1: Day 1: obinutuzumab 100 mg Day 1 (or 2): obinutuzumab 900 mg Day 8: obinutuzumab 1000 mg Day 15: obinutuzumab 1000 mg Cycles 2-6: Day 1: obinutuzumab1000 mg

    Investigational medicinal product name
    Ibrutinib
    Investigational medicinal product code
    PCI-32765
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will receive ibrutinib as a daily oral dosage of 420 mg starting on cycle 1 day 1 until MRD negativity (i.e. < 10-4) in peripheral blood and confirmed by a bone marrow aspirate or by two consecutive peripheral blood samples (cycle 9/12 or 12/15; all other patients will continue treatment) or 36 months of treatment are reached. Ibrutinib p.o.: Cycles 1-12: Days 1-28: 420mg daily Cycles 13-36: Days 1-28: ibrutinib 420 mg daily

    Number of subjects in period 1
    		Standard chemoimmunotherapy (SCIT) Venetoclax, rituximab (RVe) Venetoclax, obinutuzumab (GVe) Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Started
    229
    237
    229
    231
    Completed
    176
    219
    214
    199
    Not completed
    53
    18
    15
    32
         Adverse event, non-fatal
    32
    11
    9
    27
         Death
    -
    1
    1
    2
         Non-compliance
    2
    -
    1
    -
         Progressive disease
    2
    4
    3
    -
         Did not receive any study treatment
    13
    -
    1
    -
         other reason
    4
    2
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard chemoimmunotherapy (SCIT)
    Reporting group description
    		 The SCIT treatment consists of 6 cycles, each with a precise duration of 28 days. Patients ≤ 65 years will receive 6 cycles of fludarabine, cyclophosphamide and rituximab (FCR). Patients > 65 years will receive 6 cycles of bendamusine and rituximab (BR).

    Reporting group title
    Venetoclax, rituximab (RVe)
    Reporting group description
    		 The RVe treatment consists of 12 cycles, each with a precise duration of 28 days.

    Reporting group title
    Venetoclax, obinutuzumab (GVe)
    Reporting group description
    		 The GVe treatment consists of 12 cycles, each with a precise duration of 28 days.

    Reporting group title
    Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Reporting group description
    		 The GIVe treatment consists of 12 cycles (ibrutinib might be given up to 36 cycles), each with a precise duration of 28 days.

    Reporting group values
    		 Standard chemoimmunotherapy (SCIT) Venetoclax, rituximab (RVe) Venetoclax, obinutuzumab (GVe) Venetoclax, obinutuzmab, ibrutinib (GIVe) Total
    Number of subjects
    		 229 237 229 231 926
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 145 141 139 139 564
        From 65-84 years
    		 84 96 90 92 362
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 66 62 58 73 259
        Male
    		 163 175 171 158 667
    Country
    Units: Subjects
        Germany
    		 85 85 81 82 333
        Denmark
    		 25 31 25 32 113
        Netherlands
    		 43 47 49 46 185
        Sweden
    		 14 13 17 9 53
        Switzerland
    		 21 21 21 19 82
        Belgium
    		 12 7 5 7 31
        Austria
    		 8 9 11 8 36
        Finland
    		 6 4 5 6 21
        Ireland
    		 8 9 10 11 38
        Israel
    		 7 11 5 11 34
    Binet stage
    Units: Subjects
        Binet A
    		 63 61 58 63 245
        Binet B
    		 84 92 91 84 351
        Binet C
    		 82 84 80 84 330
    IGHV mutational status
    Units: Subjects
        unmutated
    		 131 134 130 123 518
        mutated
    		 95 95 89 101 380
        not evaluable
    		 3 8 9 7 27
        missing information
    		 0 0 1 0 1
    CLL-IPI risk group
    Units: Subjects
        low
    		 36 39 32 36 143
        intermediate
    		 67 66 76 85 294
        high
    		 122 123 109 101 455
        very high
    		 0 0 0 0 0
        missing information
    		 4 9 12 9 34
    Complex karyotype
    Units: Subjects
        < 3 aberrations
    		 177 187 182 196 742
        ≥ 3 and < 5 aberrations
    		 30 34 25 21 110
        ≥ 5 aberrations
    		 16 10 11 6 43
        missing information
    		 6 6 11 8 31
    Binet stage used for stratification
    Units: Subjects
        Binet A
    		 61 62 60 63 246
        Binet B
    		 85 90 90 84 349
        Binet C
    		 83 85 79 84 331

    End points

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    End points reporting groups
    Reporting group title
    Standard chemoimmunotherapy (SCIT)
    Reporting group description
    		 The SCIT treatment consists of 6 cycles, each with a precise duration of 28 days. Patients ≤ 65 years will receive 6 cycles of fludarabine, cyclophosphamide and rituximab (FCR). Patients > 65 years will receive 6 cycles of bendamusine and rituximab (BR).

    Reporting group title
    Venetoclax, rituximab (RVe)
    Reporting group description
    		 The RVe treatment consists of 12 cycles, each with a precise duration of 28 days.

    Reporting group title
    Venetoclax, obinutuzumab (GVe)
    Reporting group description
    		 The GVe treatment consists of 12 cycles, each with a precise duration of 28 days.

    Reporting group title
    Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Reporting group description
    		 The GIVe treatment consists of 12 cycles (ibrutinib might be given up to 36 cycles), each with a precise duration of 28 days.

    Primary: Progression free survival (PFS) [GIVe versus SCIT]

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    End point title
    		 Progression free survival (PFS) [GIVe versus SCIT] [1]
    End point description
    One co-primary efficacy endpoint is the investigator-assessed PFS, defined as the time from randomization to the first occurrence of progression or relapse (determined using standard IWCLL guidelines [2008]), or death from any cause, whichever occurs first. For patients who have not progressed, relapsed, or died at the time of analysis, PFS will be censored on the date of the last tumor assessment. In case of initiation of subsequent anti-leukemic treatment without documented disease progression patient will be censored at last tumor assessment prior to start of subsequent therapy. If no tumor assessments were performed after the screening visit, PFS will be censored at the time of randomization + 1 day. Median PFS and the 97.5% CI will be estimated using Kaplan-Meier survival methodology, with the Kaplan-Meier survival curve presented to provide a visual description. PFS rates for 1, 2 and 3 years etc. after randomization will be reported.
    End point type
    Primary
    End point timeframe
    Data will be collected from randomization until last visit of each study subject.
    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 statistics for the comparisons of the other arms are reported in a separate endpoint as only the comparison between GIVE versus SCIT was considered as primary endpoint in this analysis. The other comparisons are considered as secondary endpoint and are reported as secondary endpoint accordingly.
    End point values
    		 Standard chemoimmunotherapy (SCIT) Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects analysed
    229
    231 [2]
    Units: Percentage
    number (not applicable)
        1-year survival
    93.4
    98.3
        2-year survival
    82.6
    96.1
        3-year survival
    75.9
    91.3
        4-year survival
    60.8
    85.9
        5-year survival
    50.7
    81.3
        Median PFS (months)
    61.2
    0
    Notes
    [2] - Median PFS was not reached in this subgroup
    Statistical analysis title
    		 Two-sided stratified log-rank test (GIVe vs SCIT)
    Statistical analysis description
    PFS treatment comparison of GIVe and SCIT will be performed using a two-sided stratified log-rank test (considering the stratification factors age (with a cut-off of 65 years) and Binet stage). The co-primary endpoint PFS [GIVe vs. SCIT] has been formally tested during the “interim analysis of the co-primary endpoint PFS” with the data cut-off 2022.01.20. There is no alpha spend in the current analysis of the co-primary endpoint [PFS: GIVe vs. SCIT].
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox regression (GIVe vs SCIT)
    Statistical analysis description
    Estimates of the treatment effect will be expressed as HR including 97.5% CI estimated through a stratified Cox proportional hazards analysis (considering the stratification factors age (with a cut-off of 65 years) and Binet stage).
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.344
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.235
         upper limit
    		 0.503

    Primary: MRD negativity in peripheral blood at month 15 [GVe versus SCIT]

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    End point title
    		 MRD negativity in peripheral blood at month 15 [GVe versus SCIT] [3]
    End point description
    One co-primary objective of the study is to assess the MRD negativity rate. MRD negativity is defined as <1 CLL-cell among 10,000 leukocytes analyzed [0.01%], i.e. < 10-4. Values above [≥10-4] will be considered as MRD positive. The MRD negativity rate in PB at MO 15 is defined as the proportion of MRD negative patients at MO 15 based on the ITT population (= number of MRD negative patients divided by the number of the ITT population). Patients without an MRD sample in peripheral blood at MO 15 will be counted as MRD positive patients.
    End point type
    Primary
    End point timeframe
    15 months after start of treatment.
    Notes
    [3] - 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 statistics for the comparisons of the other arms are reported in a separate endpoint as only the comparison between GVE versus SCIT was considered as primary endpoint in this analysis. The other comparisons are considered as secondary endpoint and are reported as secondary endpoint accordingly.
    End point values
    		 Standard chemoimmunotherapy (SCIT) Venetoclax, rituximab (RVe)
    Number of subjects analysed
    229
    229
    Units: percentage
    number (confidence interval 97.5%)
        MRD negativity rate
    52 (44.4 to 59.5)
    86.5 (80.6 to 91.1)
    Statistical analysis title
    		 Cochran-Mantel-Haenszel test (GVe vs SCIT)
    Statistical analysis description
    MRD negativity rate of GVe and SCIT will be compared using Cochran-Mantel-Haenszel test stratified by age (with a cut-off of 65 years) and Binet stage. The co-primary endpoint MRD in PB at MO15 [GVe vs. SCIT] has been formally tested during the “co-primary endpoint analysis of MRD negativity rate at month 15” with the data cut-off 2021.02.28. There is no alpha spend in the current analysis of the co-primary endpoint [MRD in PB at MO15: GVe vs. SCIT].
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Overall survival will be measured from the date of randomization to the date of death due to any cause. Patients who have not yet died at the time of analysis will be censored at the time of last observation they were assessed to be alive.
    End point type
    Secondary
    End point timeframe
    Data for this endpoint will be collected from the date of randomization until last visit of each study subject.
    End point values
    		 Standard chemoimmunotherapy (SCIT) Venetoclax, rituximab (RVe) Venetoclax, obinutuzumab (GVe) Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects analysed
    229 [4]
    237 [5]
    229 [6]
    231 [7]
    Units: percent
    number (not applicable)
        1-year survival
    99.1
    97.9
    99.1
    98.7
        2-year survival
    98.6
    97.9
    98.2
    97
        3-year survival
    95.7
    96.6
    96.5
    95.6
        4-year survival
    93.8
    96.2
    95.2
    94.7
        5-year survival
    90.7
    94.7
    93.6
    94.3
        Median OS (months)
    0
    0
    0
    0
    Notes
    [4] - Median OS was not reached in this subgroup
    [5] - Median OS was not reached in this subgroup
    [6] - Median OS was not reached in this subgroup
    [7] - Median OS was not reached in this subgroup
    Statistical analysis title
    		 Two-sided log-rank test (GIVe vs SCIT)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter OS will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.175
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GIVe vs SCIT)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Venetoclax, obinutuzmab, ibrutinib (GIVe) v Standard chemoimmunotherapy (SCIT)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.617
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.275
         upper limit
    		 1.382
    Statistical analysis title
    		 Two-sided log-rank test (GVe vs SCIT)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter OS will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, obinutuzumab (GVe)
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.423
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GVe vs SCIT)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Standard chemoimmunotherapy (SCIT)
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.762
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.356
         upper limit
    		 1.631
    Statistical analysis title
    		 Two-sided log-rank test (RVe vs SCIT)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter OS will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.255
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (RVe vs SCIT)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.676
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.312
         upper limit
    		 1.468
    Statistical analysis title
    		 Two-sided log-rank test (GIVe vs GVe)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter OS will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.564
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GIVe vs GVe)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.806
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.349
         upper limit
    		 1.862
    Statistical analysis title
    		 Two-sided log-rank test (GVe vs RVe)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter OS will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.678
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GVe vs RVe)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.162
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.517
         upper limit
    		 2.613
    Statistical analysis title
    		 Two-sided log-rank test (GIVe vs RVe)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter OS will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Venetoclax, obinutuzmab, ibrutinib (GIVe) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.784
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GIVe vs RVe)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Venetoclax, obinutuzmab, ibrutinib (GIVe) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.901
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.385
         upper limit
    		 2.108

    Secondary: Time to next treatment (TTNT)

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    End point title
    		 Time to next treatment (TTNT)
    End point description
    TTNT will be measured from the date of randomization until the date of first anti-leukemic treatment. Patients for whom no subsequent anti-leukemic treatment is documented will be censored at the time of last observation they were assessed to be free from subsequent treatment.
    End point type
    Secondary
    End point timeframe
    Data for this endpoint will be collected from the date of randomization until last visit of each study subject.
    End point values
    		 Standard chemoimmunotherapy (SCIT) Venetoclax, rituximab (RVe) Venetoclax, obinutuzumab (GVe) Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects analysed
    229 [8]
    237 [9]
    229 [10]
    231 [11]
    Units: percent
    number (not applicable)
        1-year survival
    97.7
    97.9
    98.7
    100
        2-year survival
    93.4
    95.3
    97.8
    100
        3-year survival
    87.1
    91.8
    94.6
    98.6
        4-year survival
    77.5
    83.9
    90
    95.4
        5-year survival
    67.1
    77.1
    87.5
    92.6
        Median months
    0
    0
    0
    0
    Notes
    [8] - Median TTNT was not reached in this subgroup
    [9] - Median TTNT was not reached in this subgroup
    [10] - Median TTNT was not reached in this subgroup
    [11] - Median TTNT was not reached in this subgroup
    Statistical analysis title
    		 Two-sided log-rank test (GIVe vs SCIT)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter TTNT will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GIVe vs SCIT)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.218
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.123
         upper limit
    		 0.386
    Statistical analysis title
    		 Two-sided log-rank test (GVe vs SCIT)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter TTNT will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Standard chemoimmunotherapy (SCIT)
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GVe vs SCIT)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, obinutuzumab (GVe)
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.429
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.273
         upper limit
    		 0.676
    Statistical analysis title
    		 Two-sided log-rank test (RVe vs SCIT)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter TTNT will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Venetoclax, rituximab (RVe) v Standard chemoimmunotherapy (SCIT)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.204
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (RVe vs SCIT)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.806
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.181
    Statistical analysis title
    		 Two-sided log-rank test (GIVe vs GVe)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter TTNT will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.01
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GIVe vs GVe)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Venetoclax, obinutuzmab, ibrutinib (GIVe) v Venetoclax, obinutuzumab (GVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.498
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.268
         upper limit
    		 0.925
    Statistical analysis title
    		 Two-sided log-rank test (GVe vs RVe)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter TTNT will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0014
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GVe vs RVe)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Venetoclax, rituximab (RVe) v Venetoclax, obinutuzumab (GVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.529
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.337
         upper limit
    		 0.833
    Statistical analysis title
    		 Two-sided log-rank test (GIVe vs RVe)
    Statistical analysis description
    Treatment comparison for the secondary efficacy parameter TTNT will be performed using a two-sided non-stratified log-rank test. There is no alpha spend in the analysis of secondary endpoints.
    Comparison groups
    Venetoclax, rituximab (RVe) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GIVe vs RVe)
    Statistical analysis description
    Estimates of the treatment effect will be expressed by the hazard ratio (HR) including the 97.5% confidence interval estimated through a non-stratified Cox proportional hazard regression model.
    Comparison groups
    Venetoclax, rituximab (RVe) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.266
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.151
         upper limit
    		 0.471

    Secondary: Response rate at month 15

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    End point title
    		 Response rate at month 15
    End point description
    The overall response rate (ORR) will be defined as the proportion of patients having achieved a CR/CRi, clinical CR/CRi or PR (including PR with lymphocytosis) (according to the iwCLL guidelines (2008)) at MO 15 (= number of patients with response CR/CRi, clinical CR/CRi or PR (with or without lymphocytosis) divided by the ITT population).
    End point type
    Secondary
    End point timeframe
    15 months after start of treatment.
    End point values
    		 Standard chemoimmunotherapy (SCIT) Venetoclax, rituximab (RVe) Venetoclax, obinutuzumab (GVe) Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects analysed
    229
    237
    229
    231
    Units: Patients
        CR
    73
    112
    124
    128
        CRi
    9
    2
    4
    9
        Clinical CR
    51
    29
    21
    24
        Clinical CRi
    5
    0
    3
    4
        PR
    47
    78
    68
    53
        SD
    3
    0
    0
    0
        PD
    7
    1
    2
    1
        Missing
    34
    15
    7
    12
    No statistical analyses for this end point

    Secondary: PFS (all other comparisons except for [GIVe versus SCIT])

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    End point title
    		 PFS (all other comparisons except for [GIVe versus SCIT])
    End point description
    Progression-free survival is defined as the time from randomization to the first occurrence of progression or relapse (determined using standard IWCLL guidelines [2008]), or death from any cause, whichever occurs first. For patients who have not progressed, relapsed, or died at the time of analysis, PFS will be censored on the date of the last tumor assessment. In case of initiation of subsequent anti-leukemic treatment without documented disease progression patient will be censored at last tumor assessment prior to start of subsequent therapy. If no tumor assessments were performed after the screening visit, PFS will be censored at the time of randomization + 1 day. Median PFS and the 97.5% CI will be estimated using Kaplan-Meier survival methodology, with the Kaplan-Meier survival curve presented to provide a visual description. PFS rates for 1, 2 and 3 years etc. after randomization will be reported.
    End point type
    Secondary
    End point timeframe
    Data will be collected from randomization until last visit of each study subject
    End point values
    		 Standard chemoimmunotherapy (SCIT) Venetoclax, rituximab (RVe) Venetoclax, obinutuzumab (GVe) Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects analysed
    229
    237
    229 [12]
    231 [13]
    Units: percent
    number (not applicable)
        1-year survival
    93.4
    96.6
    97.4
    98.3
        2-year survival
    82.6
    91.9
    92.5
    96.1
        3-year survival
    75.9
    80.7
    88.6
    91.3
        4-year survival
    60.8
    71.1
    81.9
    85.9
        5-year survival
    50.7
    57.4
    69.8
    81.3
        Median PFS (months)
    61.2
    64.5
    0
    0
    Notes
    [12] - Median PFS was not reached in this subgroup
    [13] - Median PFS was not reached in this subgroup
    Statistical analysis title
    		 Two-sided log-rank test (GVe vs SCIT)
    Statistical analysis description
    PFS treatment comparisons will be performed using two-sided stratified log-rank tests (considering the stratification factors age (with a cut-off of 65 years) and Binet stage). There is no alpha spend in the current analysis of the co-primary endpoint of PFS.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Standard chemoimmunotherapy (SCIT)
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GVe vs SCIT)
    Statistical analysis description
    Estimates of the treatment effect will be expressed as HR including 97.5% CI estimated through a stratified Cox proportional hazards analysis (considering the stratification factors age (with a cut-off of 65 years) and Binet stage).
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, obinutuzumab (GVe)
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.544
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.389
         upper limit
    		 0.761
    Statistical analysis title
    		 Two-sided log-rank test (RVe vs SCIT)
    Statistical analysis description
    PFS treatment comparisons will be performed using two-sided stratified log-rank tests (considering the stratification factors age (with a cut-off of 65 years) and Binet stage). There is no alpha spend in the current analysis of the co-primary endpoint of PFS.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.53
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (RVe vs SCIT)
    Statistical analysis description
    Estimates of the treatment effect will be expressed as HR including 97.5% CI estimated through a stratified Cox proportional hazards analysis (considering the stratification factors age (with a cut-off of 65 years) and Binet stage).
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.919
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.681
         upper limit
    		 1.241
    Statistical analysis title
    		 Two-sided log-rank test (GIVe vs GVe)
    Statistical analysis description
    PFS treatment comparisons will be performed using two-sided stratified log-rank tests (considering the stratification factors age (with a cut-off of 65 years) and Binet stage). There is no alpha spend in the current analysis of the co-primary endpoint of PFS.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0046
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GIVe vs GVe)
    Statistical analysis description
    Estimates of the treatment effect will be expressed as HR including 97.5% CI estimated through a stratified Cox proportional hazards analysis (considering the stratification factors age (with a cut-off of 65 years) and Binet stage).
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.607
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.407
         upper limit
    		 0.905
    Statistical analysis title
    		 Two-sided log-rank test (GVe vs RVe)
    Statistical analysis description
    PFS treatment comparisons will be performed using two-sided stratified log-rank tests (considering the stratification factors age (with a cut-off of 65 years) and Binet stage). There is no alpha spend in the current analysis of the co-primary endpoint of PFS.
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.00019
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GVe vs RVe)
    Statistical analysis description
    Estimates of the treatment effect will be expressed as HR including 97.5% CI estimated through a stratified Cox proportional hazards analysis (considering the stratification factors age (with a cut-off of 65 years) and Binet stage).
    Comparison groups
    Venetoclax, obinutuzumab (GVe) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.586
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.424
         upper limit
    		 0.811
    Statistical analysis title
    		 Two-sided log-rank test (GIVe vs RVe)
    Statistical analysis description
    PFS treatment comparisons will be performed using two-sided stratified log-rank tests (considering the stratification factors age (with a cut-off of 65 years) and Binet stage). There is no alpha spend in the current analysis of the co-primary endpoint of PFS.
    Comparison groups
    Venetoclax, obinutuzmab, ibrutinib (GIVe) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Cox proportional hazards analysis (GIVe vs RVe)
    Statistical analysis description
    Estimates of the treatment effect will be expressed as HR including 97.5% CI estimated through a stratified Cox proportional hazards analysis (considering the stratification factors age (with a cut-off of 65 years) and Binet stage).
    Comparison groups
    Venetoclax, obinutuzmab, ibrutinib (GIVe) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    468
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.347
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.238
         upper limit
    		 0.506

    Secondary: MRD negativity in peripheral blood at month 15 (except for [GVe versus SCIT])

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    End point title
    		 MRD negativity in peripheral blood at month 15 (except for [GVe versus SCIT])
    End point description
    MRD negativity is defined as <1 CLL-cell among 10,000 leukocytes analyzed [0.01%], i.e. < 10-4. Values above [≥10-4] will be considered as MRD positive. The MRD negativity rate in PB at MO 15 is defined as the proportion of MRD negative patients at MO 15 based on the ITT population (= number of MRD negative patients divided by the number of the ITT population). Patients without an MRD sample in peripheral blood at MO 15 will be counted as MRD positive patients.
    End point type
    Secondary
    End point timeframe
    15 months after start of treatment.
    End point values
    		 Standard chemoimmunotherapy (SCIT) Venetoclax, rituximab (RVe) Venetoclax, obinutuzumab (GVe) Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects analysed
    229
    237
    229
    231
    Units: percent
    number (confidence interval 97.5%)
        MRD negativity rate
    52 (44.4 to 59.5)
    57 (49.5 to 64.2)
    86.5 (80.6 to 91.1)
    92.2 (87.3 to 95.7)
    Statistical analysis title
    		 Cochran-Mantel-Haenszel test (GIVe vs SCIT)
    Statistical analysis description
    MRD negativity rates of treatment groups will be compared using Cochran-Mantel-Haenszel test stratified by age (with a cut-off of 65 years) and Binet stage. There is no alpha spend in the current analysis of the co-primary endpoint of MRD negativity rate at month 15.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, obinutuzmab, ibrutinib (GIVe)
    Number of subjects included in analysis
    460
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Cochran-Mantel-Haenszel test (RVe vs SCIT)
    Statistical analysis description
    MRD negativity rates of treatment groups will be compared using Cochran-Mantel-Haenszel test stratified by age (with a cut-off of 65 years) and Binet stage. There is no alpha spend in the current analysis of the co-primary endpoint of MRD negativity rate at month 15.
    Comparison groups
    Standard chemoimmunotherapy (SCIT) v Venetoclax, rituximab (RVe)
    Number of subjects included in analysis
    466
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.317
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    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
    GVe arm
    Reporting group description
    		 -

    Reporting group title
    SCIT arm
    Reporting group description
    		 -

    Reporting group title
    RVe arm
    Reporting group description
    		 -

    Reporting group title
    GIVe arm
    Reporting group description
    		 -

    Serious adverse events
    		 GVe arm SCIT arm RVe arm GIVe arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    136 / 228 (59.65%)
    145 / 216 (67.13%)
    131 / 237 (55.27%)
    146 / 231 (63.20%)
         number of deaths (all causes)
    15
    19
    15
    13
         number of deaths resulting from adverse events
    14
    18
    14
    13
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
    Additional description: Acute myeloid leukaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Adenocarcinoma pancreas
    Additional description: Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    3 / 228 (1.32%)
    4 / 216 (1.85%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 5
    0 / 0
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
    Additional description: Bladder cancer
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Bowen's disease
    Additional description: Bowen's disease
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
    Additional description: Breast cancer
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondrosarcoma
    Additional description: Chondrosarcoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central nervous system leukaemia
    Additional description: Central nervous system leukaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
    Additional description: Colon cancer
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    Dedifferentiated liposarcoma
    Additional description: Dedifferentiated liposarcoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Follicular lymphoma
    Additional description: Follicular lymphoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma
    Additional description: Glioblastoma
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Hepatocellular carcinoma
    Additional description: Hepatocellular carcinoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hypopharyngeal cancer
    Additional description: Hypopharyngeal cancer
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
    Additional description: Lipoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of unknown primary site
    Additional description: Malignant neoplasm of unknown primary site
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Lung adenocarcinoma
    Additional description: Lung adenocarcinoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
    Additional description: Lung neoplasm malignant
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
    Additional description: Malignant melanoma
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mantle cell lymphoma
    Additional description: Mantle cell lymphoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma
    Additional description: Meningioma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma benign
    Additional description: Meningioma benign
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic gastric cancer
    Additional description: Metastatic gastric cancer
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Myelodysplastic syndrome
    Additional description: Myelodysplastic syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myxoid liposarcoma
    Additional description: Myxoid liposarcoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer
    Additional description: Non-small cell lung cancer
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
    Additional description: Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Oesophageal carcinoma
    Additional description: Oesophageal carcinoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian adenoma
    Additional description: Ovarian adenoma
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phaeochromocytoma
    Additional description: Phaeochromocytoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
    Additional description: Plasma cell myeloma
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
    Additional description: Papillary thyroid cancer
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polycythaemia vera
    Additional description: Polycythaemia vera
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
    Additional description: Prostate cancer
         subjects affected / exposed
    4 / 228 (1.75%)
    3 / 216 (1.39%)
    1 / 237 (0.42%)
    4 / 231 (1.73%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Prostate cancer metastatic
    Additional description: Prostate cancer metastatic
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
    Additional description: Rectal adenocarcinoma
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
    Additional description: Rectal cancer
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Cell Carcinoma
    Additional description: Renal Cell Carcinoma
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Richter's syndrome
    Additional description: Richter's syndrome
         subjects affected / exposed
    7 / 228 (3.07%)
    5 / 216 (2.31%)
    6 / 237 (2.53%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 5
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    1 / 3
    0 / 4
    0 / 1
    Salivary gland adenoma
    Additional description: Salivary gland adenoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland cancer
    Additional description: Salivary gland cancer
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seborrhoeic keratosis
    Additional description: Seborrhoeic keratosis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
    Additional description: Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin squamous cell carcinoma metastatic
    Additional description: Skin squamous cell carcinoma metastatic
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Small cell lung cancer
    Additional description: Small cell lung cancer
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Soft tissue sarcoma
    Additional description: Soft tissue sarcoma
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord neoplasm
    Additional description: Spinal cord neoplasm
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
    Additional description: Squamous cell carcinoma
         subjects affected / exposed
    4 / 228 (1.75%)
    6 / 216 (2.78%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 6
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
    Additional description: Uterine leiomyoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
    Additional description: Aortic aneurysm
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic stenosis
    Additional description: Aortic stenosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blue toe syndrome
    Additional description: Blue toe syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
    Additional description: Orthostatic hypotension
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
    Additional description: Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
    Additional description: Peripheral ischaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyarteritis nodosa
    Additional description: Polyarteritis nodosa
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
    Additional description: Thrombophlebitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Chest tube removal
    Additional description: Chest tube removal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystectomy
    Additional description: Cholecystectomy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary arterial stent insertion
    Additional description: Coronary arterial stent insertion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery bypass
    Additional description: Coronary artery bypass
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epidermoid cyst excision
    Additional description: Epidermoid cyst excision
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ethmoid sinus surgery
    Additional description: Ethmoid sinus surgery
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrectomy
    Additional description: Gastrectomy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip arthroplasty
    Additional description: Hip arthroplasty
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip surgery
    Additional description: Hip surgery
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
    Additional description: Adverse drug reaction
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
    Additional description: Death
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza like illness
    Additional description: Influenza like illness
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Puncture site haematoma
    Additional description: Puncture site haematoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    8 / 228 (3.51%)
    10 / 216 (4.63%)
    8 / 237 (3.38%)
    4 / 231 (1.73%)
         occurrences causally related to treatment / all
    7 / 8
    11 / 12
    5 / 8
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
    Additional description: Anaphylactic reaction
         subjects affected / exposed
    3 / 228 (1.32%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytokine release syndrome
    Additional description: Cytokine release syndrome
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
    Additional description: Drug hypersensitivity
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sarcoidosis
    Additional description: Sarcoidosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
    Additional description: Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genital prolapse
    Additional description: Genital prolapse
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Menorrhagia
    Additional description: Menorrhagia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectocele
    Additional description: Rectocele
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
    Additional description: Bronchial obstruction
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Bronchitis chronic
    Additional description: Bronchitis chronic
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal septum disorder
    Additional description: Nasal septum disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obliterative bronchiolitis
    Additional description: Obliterative bronchiolitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
    Additional description: Pleuritic pain
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
    Additional description: Pneumonitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
    Additional description: Pneumothorax
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    2 / 228 (0.88%)
    2 / 216 (0.93%)
    3 / 237 (1.27%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary fibrosis
    Additional description: Pulmonary fibrosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
    Additional description: Pulmonary mass
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
    Additional description: Respiratory failure
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Upper-airway cough syndrome
    Additional description: Upper-airway cough syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
    Additional description: Completed suicide
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Delirium
    Additional description: Delirium
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
    Additional description: Depression
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
    Additional description: Suicide attempt
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood lactate dehydrogenase increased
    Additional description: Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatine increased
    Additional description: Blood creatine increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
    Additional description: Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood phosphorus increased
    Additional description: Blood phosphorus increased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood potassium increased
    Additional description: Blood potassium increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
    Additional description: Hepatic enzyme increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical observation
    Additional description: Medical observation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial necrosis marker increased
    Additional description: Myocardial necrosis marker increased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    N-terminal prohormone brain natriuretic peptide increased
    Additional description: N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic specific antigen increased
    Additional description: Prostatic specific antigen increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SARS-CoV-2 test positive
    Additional description: SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
    Additional description: Transaminases increased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
    Additional description: Alcohol poisoning
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
    Additional description: Ankle fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
    Additional description: Forearm fracture
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
    Additional description: Facial bones fracture
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
    Additional description: Fall
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
    Additional description: Femoral neck fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
    Additional description: Femur fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
    Additional description: Fibula fracture
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
    Additional description: Foot fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
    Additional description: Hand fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
    Additional description: Hip fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
    Additional description: Humerus fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
    Additional description: Infusion related reaction
         subjects affected / exposed
    20 / 228 (8.77%)
    9 / 216 (4.17%)
    20 / 237 (8.44%)
    11 / 231 (4.76%)
         occurrences causally related to treatment / all
    22 / 22
    10 / 12
    22 / 22
    10 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney rupture
    Additional description: Kidney rupture
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
    Additional description: Lumbar vertebral fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
    Additional description: Multiple fractures
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
    Additional description: Multiple injuries
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
    Additional description: Meniscus injury
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
    Additional description: Post procedural haematoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural intestinal perforation
    Additional description: Procedural intestinal perforation
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reactive gastropathy
    Additional description: Reactive gastropathy
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Silicosis
    Additional description: Silicosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
    Additional description: Road traffic accident
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
    Additional description: Skull fracture
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
    Additional description: Spinal compression fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
    Additional description: Spinal fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
    Additional description: Thermal burn
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
    Additional description: Subdural haematoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
    Additional description: Thoracic vertebral fracture
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
    Additional description: Tibia fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
    Additional description: Ulna fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
    Additional description: Wrist fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Adenomatous polyposis coli
    Additional description: Adenomatous polyposis coli
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
    Additional description: Acute coronary syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
    Additional description: Acute myocardial infarction
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
    Additional description: Atrial tachycardia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve disease
    Additional description: Aortic valve disease
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
    Additional description: Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    3 / 228 (1.32%)
    7 / 216 (3.24%)
    3 / 237 (1.27%)
    6 / 231 (2.60%)
         occurrences causally related to treatment / all
    2 / 4
    2 / 7
    0 / 3
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
    Additional description: Angina pectoris
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 4
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
    Additional description: Atrioventricular block
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
    Additional description: Cardiac arrest
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cardiac failure congestive
    Additional description: Cardiac failure congestive
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy
    Additional description: Cardiomyopathy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
    Additional description: Coronary artery disease
         subjects affected / exposed
    3 / 228 (1.32%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracardiac thrombus
    Additional description: Intracardiac thrombus
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
    Additional description: Myocardial infarction
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
    Additional description: Myocarditis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
    Additional description: Pericarditis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
    Additional description: Sinus node dysfunction
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
    Additional description: Stress cardiomyopathy
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
    Additional description: Supraventricular tachycardia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
    Additional description: Ventricular fibrillation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
    Additional description: Carotid artery stenosis
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery occlusion
    Additional description: Carotid artery occlusion
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar stroke
    Additional description: Cerebellar stroke
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
    Additional description: Cerebral haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
    Additional description: Cerebral ischaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
    Additional description: Cerebrovascular accident
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysaesthesia
    Additional description: Dysaesthesia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic cerebral infarction
    Additional description: Embolic cerebral infarction
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis autoimmune
    Additional description: Encephalitis autoimmune
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
    Additional description: Epilepsy
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
    Additional description: Haemorrhagic stroke
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Headache
    Additional description: Headache
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
    Additional description: Ischaemic stroke
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Myasthenia gravis
    Additional description: Myasthenia gravis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
    Additional description: Polyneuropathy
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
    Additional description: Seizure
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombotic stroke
    Additional description: Thrombotic stroke
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic leukoencephalopathy
    Additional description: Toxic leukoencephalopathy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Transient global amnesia
    Additional description: Transient global amnesia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
    Additional description: Transient ischaemic attack
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord paresis
    Additional description: Vocal cord paresis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    2 / 228 (0.88%)
    4 / 216 (1.85%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 4
    0 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aplasia pure red cell
    Additional description: Aplasia pure red cell
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune haemolytic anaemia
    Additional description: Autoimmune haemolytic anaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune neutropenia
    Additional description: Autoimmune neutropenia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
    Additional description: Febrile neutropenia
         subjects affected / exposed
    8 / 228 (3.51%)
    21 / 216 (9.72%)
    7 / 237 (2.95%)
    17 / 231 (7.36%)
         occurrences causally related to treatment / all
    6 / 8
    23 / 26
    7 / 7
    17 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia
    Additional description: Haemolytic anaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Immune thrombocytopenia
    Additional description: Immune thrombocytopenia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukostasis syndrome
    Additional description: Leukostasis syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
    Additional description: Lymphadenitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphocytosis
    Additional description: Lymphocytosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    4 / 228 (1.75%)
    2 / 216 (0.93%)
    3 / 237 (1.27%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
    Additional description: Pancytopenia
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenomegaly
    Additional description: Splenomegaly
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    8 / 228 (3.51%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    7 / 8
    1 / 2
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
    Additional description: Vertigo positional
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Acute macular outer retinopathy
    Additional description: Acute macular outer retinopathy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
    Additional description: Cataract
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dacryostenosis acquired
    Additional description: Dacryostenosis acquired
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eyelid cyst
    Additional description: Eyelid cyst
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular hole
    Additional description: Macular hole
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
    Additional description: Optic ischaemic neuropathy
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
    Additional description: Retinal detachment
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous stasis retinopathy
    Additional description: Venous stasis retinopathy
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
    Additional description: Abdominal hernia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
    Additional description: Diverticulum intestinal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal perforation
    Additional description: Duodenal perforation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Duodenal ulcer haemorrhage
    Additional description: Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enlarged uvula
    Additional description: Enlarged uvula
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiploic appendagitis
    Additional description: Epiploic appendagitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erosive oesophagitis
    Additional description: Erosive oesophagitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
    Additional description: Gastritis erosive
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
    Additional description: Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
    Additional description: Haemorrhagic erosive gastritis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
    Additional description: Ileus
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
    Additional description: Impaired gastric emptying
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
    Additional description: Inguinal hernia
         subjects affected / exposed
    0 / 228 (0.00%)
    3 / 216 (1.39%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
    Additional description: Irritable bowel syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal rupture
    Additional description: Oesophageal rupture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatolithiasis
    Additional description: Pancreatolithiasis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
    Additional description: Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
    Additional description: Bile duct stenosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
    Additional description: Biliary colic
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
    Additional description: Cholecystitis
         subjects affected / exposed
    3 / 228 (1.32%)
    4 / 216 (1.85%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
    Additional description: Cholecystitis acute
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder polyp
    Additional description: Gallbladder polyp
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatotoxicity
    Additional description: Hepatotoxicity
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
    Additional description: Liver disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcapsular hepatic haematoma
    Additional description: Subcapsular hepatic haematoma
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
    Additional description: Actinic keratosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis
    Additional description: Dermatitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis allergic
    Additional description: Dermatitis allergic
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erythema multiforme
    Additional description: Erythema multiforme
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
    Additional description: Rash
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash maculo-papular
    Additional description: Rash maculo-papular
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Nephrolithiasis
    Additional description: Nephrolithiasis
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
    Additional description: Renal colic
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
    Additional description: Ureterolithiasis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral caruncle
    Additional description: Urethral caruncle
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
    Additional description: Urethral stenosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
    Additional description: Goitre
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
    Additional description: Hyperthyroidism
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dupuytren's contracture
    Additional description: Dupuytren's contracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gouty arthritis
    Additional description: Gouty arthritis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
    Additional description: Haemarthrosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma muscle
    Additional description: Haematoma muscle
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercreatinaemia
    Additional description: Hypercreatinaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
    Additional description: Osteochondrosis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
    Additional description: Osteonecrosis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoporotic fracture
    Additional description: Osteoporotic fracture
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    4 / 228 (1.75%)
    2 / 216 (0.93%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periarthritis
    Additional description: Periarthritis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia rheumatica
    Additional description: Polymyalgia rheumatica
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
    Additional description: Rotator cuff syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scleroderma
    Additional description: Scleroderma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
    Additional description: Spinal column stenosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
    Additional description: Spinal pain
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
    Additional description: Tenosynovitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
    Additional description: Anal abscess
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
    Additional description: Abscess limb
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess
    Additional description: Abscess
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
    Additional description: Appendicitis
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
    Additional description: Appendicitis perforated
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asymptomatic COVID-19
    Additional description: Asymptomatic COVID-19
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
    Additional description: Bacteraemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
    Additional description: Bacterial infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
    Additional description: Atypical pneumonia
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
    Additional description: Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral aspergillosis
    Additional description: Cerebral aspergillosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
    Additional description: Chronic sinusitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corona virus infection
    Additional description: Corona virus infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronavirus infection
    Additional description: Coronavirus infection
         subjects affected / exposed
    0 / 228 (0.00%)
    3 / 216 (1.39%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
    Additional description: COVID-19
         subjects affected / exposed
    13 / 228 (5.70%)
    6 / 216 (2.78%)
    13 / 237 (5.49%)
    8 / 231 (3.46%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 6
    0 / 14
    0 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    0 / 1
    COVID-19 pneumonia
    Additional description: COVID-19 pneumonia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    3 / 237 (1.27%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cryptococcal fungaemia
    Additional description: Cryptococcal fungaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
    Additional description: Cytomegalovirus infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection reactivation
    Additional description: Cytomegalovirus infection reactivation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
    Additional description: Diverticulitis
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis fungal
    Additional description: Encephalitis fungal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Endocarditis
    Additional description: Endocarditis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
    Additional description: Erysipelas
         subjects affected / exposed
    3 / 228 (1.32%)
    4 / 216 (1.85%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 4
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
    Additional description: Epididymitis
         subjects affected / exposed
    3 / 228 (1.32%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epstein-Barr virus infection
    Additional description: Epstein-Barr virus infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Enterocolitis infectious
    Additional description: Enterocolitis infectious
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
    Additional description: Escherichia urinary tract infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile infection
    Additional description: Febrile infection
         subjects affected / exposed
    0 / 228 (0.00%)
    5 / 216 (2.31%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
    Additional description: Escherichia bacteraemia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder empyema
    Additional description: Gallbladder empyema
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
    Additional description: Gastrointestinal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genital herpes zoster
    Additional description: Genital herpes zoster
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Giardiasis
    Additional description: Giardiasis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis B
    Additional description: Hepatitis B
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis B reactivation
    Additional description: Hepatitis B reactivation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis E
    Additional description: Hepatitis E
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    0 / 228 (0.00%)
    8 / 216 (3.70%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 8
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster meningoencephalitis
    Additional description: Herpes zoster meningoencephalitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster reactivation
    Additional description: Herpes zoster reactivation
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impetigo
    Additional description: Impetigo
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected seroma
    Additional description: Infected seroma
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
    Additional description: Infection
         subjects affected / exposed
    3 / 228 (1.32%)
    5 / 216 (2.31%)
    6 / 237 (2.53%)
    5 / 231 (2.16%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 6
    0 / 6
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
    Additional description: Infectious pleural effusion
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
    Additional description: Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    2 / 228 (0.88%)
    7 / 216 (3.24%)
    7 / 237 (2.95%)
    5 / 231 (2.16%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 7
    2 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Keratitis bacterial
    Additional description: Keratitis bacterial
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
    Additional description: Kidney infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
    Additional description: Laryngitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Lung infection
    Additional description: Lung infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lyme disease
    Additional description: Lyme disease
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymph gland infection
    Additional description: Lymph gland infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
    Additional description: Localised infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis
    Additional description: Meningitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis viral
    Additional description: Meningitis viral
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mycoplasma infection
    Additional description: Mycoplasma infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic infection
    Additional description: Neutropenic infection
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelitis
    Additional description: Myelitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
    Additional description: Osteomyelitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
    Additional description: Pelvic abscess
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
    Additional description: Pharyngitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papilloma viral infection
    Additional description: Papilloma viral infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
    Additional description: Parainfluenzae virus infection
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural infection
    Additional description: Pleural infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
    Additional description: Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 228 (0.00%)
    3 / 216 (1.39%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    17 / 228 (7.46%)
    18 / 216 (8.33%)
    17 / 237 (7.17%)
    19 / 231 (8.23%)
         occurrences causally related to treatment / all
    12 / 25
    12 / 24
    4 / 19
    14 / 22
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    Pneumonia adenoviral
    Additional description: Pneumonia adenoviral
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia influenzal
    Additional description: Pneumonia influenzal
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia legionella
    Additional description: Pneumonia legionella
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
    Additional description: Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
    Additional description: Pneumonia pneumococcal
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia staphylococcal
    Additional description: Pneumonia staphylococcal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia streptococcal
    Additional description: Pneumonia streptococcal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia fungal
    Additional description: Pneumonia fungal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomonas infection
    Additional description: Pseudomonas infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal abscess
    Additional description: Rectal abscess
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
    Additional description: Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
    Additional description: Respiratory tract infection
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sialoadenitis
    Additional description: Sialoadenitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
    Additional description: Sepsis
         subjects affected / exposed
    3 / 228 (1.32%)
    3 / 216 (1.39%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 3
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    Septic shock
    Additional description: Septic shock
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Sinobronchitis
    Additional description: Sinobronchitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
    Additional description: Skin infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
    Additional description: Staphylococcal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal infection
    Additional description: Streptococcal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
    Additional description: Streptococcal sepsis
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
    Additional description: Subcutaneous abscess
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suspected COVID-19
    Additional description: Suspected COVID-19
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
    Additional description: Staphylococcal sepsis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
    Additional description: Tooth abscess
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth infection
    Additional description: Tooth infection
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    3 / 237 (1.27%)
    4 / 231 (1.73%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    2 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
    Additional description: Vestibular neuronitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    2 / 228 (0.88%)
    4 / 216 (1.85%)
    6 / 237 (2.53%)
    7 / 231 (3.03%)
         occurrences causally related to treatment / all
    1 / 5
    2 / 4
    5 / 7
    4 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperphosphataemia
    Additional description: Hyperphosphataemia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    4 / 237 (1.69%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperuricaemia
    Additional description: Hyperuricaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    3 / 237 (1.27%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
    Additional description: Hypoglycaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypophosphataemia
    Additional description: Hypophosphataemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour lysis syndrome
    Additional description: Tumour lysis syndrome
         subjects affected / exposed
    9 / 228 (3.95%)
    4 / 216 (1.85%)
    11 / 237 (4.64%)
    6 / 231 (2.60%)
         occurrences causally related to treatment / all
    9 / 9
    4 / 4
    12 / 12
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GVe arm SCIT arm RVe arm GIVe arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    224 / 228 (98.25%)
    214 / 216 (99.07%)
    233 / 237 (98.31%)
    231 / 231 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
    Additional description: Adenocarcinoma of colon
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Anogenital warts
    Additional description: Anogenital warts
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Angiomyolipoma
    Additional description: Angiomyolipoma
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    5 / 228 (2.19%)
    15 / 216 (6.94%)
    11 / 237 (4.64%)
    4 / 231 (1.73%)
         occurrences all number
    5
    19
    14
    4
    Benign soft tissue neoplasm
    Additional description: Benign soft tissue neoplasm
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Bowen's disease
    Additional description: Bowen's disease
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Choroid melanoma
    Additional description: Choroid melanoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Colon adenoma
    Additional description: Colon adenoma
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Colon cancer
    Additional description: Colon cancer
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Cutaneous T-cell lymphoma
    Additional description: Cutaneous T-cell lymphoma
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Erythroplasia
    Additional description: Erythroplasia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Fibroma
    Additional description: Fibroma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemangioma
    Additional description: Haemangioma
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    2
    1
    Haemangioma of liver
    Additional description: Haemangioma of liver
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Keratoacanthoma
    Additional description: Keratoacanthoma
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lipoma
    Additional description: Lipoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Malignant melanoma
    Additional description: Malignant melanoma
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    4
    2
    1
    1
    Melanocytic naevus
    Additional description: Melanocytic naevus
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Malignant melanoma in situ
    Additional description: Malignant melanoma in situ
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    1
    0
    2
    Myelodysplastic syndrome
    Additional description: Myelodysplastic syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Myelofibrosis
    Additional description: Myelofibrosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Non-small cell lung cancer
    Additional description: Non-small cell lung cancer
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Papilloma
    Additional description: Papilloma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Plasmacytoma
    Additional description: Plasmacytoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Polycythaemia vera
    Additional description: Polycythaemia vera
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Prostate cancer
    Additional description: Prostate cancer
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    3 / 231 (1.30%)
         occurrences all number
    1
    1
    1
    3
    Schwannoma
    Additional description: Schwannoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Seborrhoeic keratosis
    Additional description: Seborrhoeic keratosis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Richter's syndrome
    Additional description: Richter's syndrome
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    1
    1
    Skin papilloma
    Additional description: Skin papilloma
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    3 / 237 (1.27%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Squamous cell carcinoma
    Additional description: Squamous cell carcinoma
         subjects affected / exposed
    3 / 228 (1.32%)
    5 / 216 (2.31%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    3
    7
    1
    1
    T-cell lymphoma
    Additional description: T-cell lymphoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Thyroid neoplasm
    Additional description: Thyroid neoplasm
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Transitional cell carcinoma
    Additional description: Transitional cell carcinoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular disorders
    Aortic aneurysm
    Additional description: Aortic aneurysm
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aortic dilatation
    Additional description: Aortic dilatation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Arteriosclerosis
    Additional description: Arteriosclerosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Blood pressure fluctuation
    Additional description: Blood pressure fluctuation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blue toe syndrome
    Additional description: Blue toe syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Circulatory collapse
    Additional description: Circulatory collapse
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Embolism
    Additional description: Embolism
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    1
    1
    Flushing
    Additional description: Flushing
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    1
    1
    1
    2
    Gestational hypertension
    Additional description: Gestational hypertension
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    9 / 228 (3.95%)
    4 / 216 (1.85%)
    4 / 237 (1.69%)
    29 / 231 (12.55%)
         occurrences all number
    9
    5
    4
    35
    Haemorrhage
    Additional description: Haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Hot flush
    Additional description: Hot flush
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    5 / 237 (2.11%)
    9 / 231 (3.90%)
         occurrences all number
    1
    3
    6
    9
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    5 / 228 (2.19%)
    10 / 216 (4.63%)
    5 / 237 (2.11%)
    4 / 231 (1.73%)
         occurrences all number
    5
    11
    7
    4
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    23 / 228 (10.09%)
    6 / 216 (2.78%)
    17 / 237 (7.17%)
    29 / 231 (12.55%)
         occurrences all number
    25
    10
    17
    32
    Peripheral arterial occlusive disease
    Additional description: Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Peripheral coldness
    Additional description: Peripheral coldness
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Phlebitis
    Additional description: Phlebitis
         subjects affected / exposed
    3 / 228 (1.32%)
    4 / 216 (1.85%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    3
    4
    2
    0
    Poor peripheral circulation
    Additional description: Poor peripheral circulation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Raynaud's phenomenon
    Additional description: Raynaud's phenomenon
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Thrombophlebitis
    Additional description: Thrombophlebitis
         subjects affected / exposed
    2 / 228 (0.88%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    2
    0
    2
    Thrombophlebitis superficial
    Additional description: Thrombophlebitis superficial
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    0
    1
    Thrombosis
    Additional description: Thrombosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Varicose vein
    Additional description: Varicose vein
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vasculitis
    Additional description: Vasculitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Venous thrombosis
    Additional description: Venous thrombosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Surgical and medical procedures
    Cranial remodelling therapy
    Additional description: Cranial remodelling therapy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Endodontic procedure
    Additional description: Endodontic procedure
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Joint irrigation
    Additional description: Joint irrigation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mastoidectomy
    Additional description: Mastoidectomy
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Polypectomy
    Additional description: Polypectomy
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Tooth extraction
    Additional description: Tooth extraction
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    3
    General disorders and administration site conditions
    Axillary pain
    Additional description: Axillary pain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    5 / 228 (2.19%)
    9 / 216 (4.17%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences all number
    5
    10
    2
    3
    Catheter site extravasation
    Additional description: Catheter site extravasation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Catheter site pain
    Additional description: Catheter site pain
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    2
    1
    1
    Catheter site swelling
    Additional description: Catheter site swelling
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chest discomfort
    Additional description: Chest discomfort
         subjects affected / exposed
    4 / 228 (1.75%)
    1 / 216 (0.46%)
    3 / 237 (1.27%)
    1 / 231 (0.43%)
         occurrences all number
    4
    1
    3
    1
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    2 / 228 (0.88%)
    11 / 216 (5.09%)
    7 / 237 (2.95%)
    5 / 231 (2.16%)
         occurrences all number
    3
    11
    7
    5
    Chills
    Additional description: Chills
         subjects affected / exposed
    13 / 228 (5.70%)
    13 / 216 (6.02%)
    13 / 237 (5.49%)
    14 / 231 (6.06%)
         occurrences all number
    13
    15
    14
    14
    Catheter site bruise
    Additional description: Catheter site bruise
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Cyst
    Additional description: Cyst
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Drug intolerance
    Additional description: Drug intolerance
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Discomfort
    Additional description: Discomfort
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Extravasation
    Additional description: Extravasation
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    2
    0
    1
    Face oedema
    Additional description: Face oedema
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    76 / 228 (33.33%)
    74 / 216 (34.26%)
    79 / 237 (33.33%)
    80 / 231 (34.63%)
         occurrences all number
    92
    91
    92
    87
    Feeling cold
    Additional description: Feeling cold
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gait disturbance
    Additional description: Gait disturbance
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Feeling hot
    Additional description: Feeling hot
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    1
    0
    1
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    4 / 231 (1.73%)
         occurrences all number
    0
    1
    2
    4
    Inflammation
    Additional description: Inflammation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Induration
    Additional description: Induration
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Influenza like illness
    Additional description: Influenza like illness
         subjects affected / exposed
    26 / 228 (11.40%)
    10 / 216 (4.63%)
    11 / 237 (4.64%)
    19 / 231 (8.23%)
         occurrences all number
    32
    11
    12
    21
    Infusion site extravasation
    Additional description: Infusion site extravasation
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Injection site pain
    Additional description: Injection site pain
         subjects affected / exposed
    0 / 228 (0.00%)
    3 / 216 (1.39%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Injection site reaction
    Additional description: Injection site reaction
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Injection site swelling
    Additional description: Injection site swelling
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    6 / 228 (2.63%)
    2 / 216 (0.93%)
    6 / 237 (2.53%)
    9 / 231 (3.90%)
         occurrences all number
    6
    4
    6
    12
    Mass
    Additional description: Mass
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 216 (1.39%)
    3 / 237 (1.27%)
    5 / 231 (2.16%)
         occurrences all number
    1
    3
    4
    6
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    2
    1
    Oedema
    Additional description: Oedema
         subjects affected / exposed
    5 / 228 (2.19%)
    9 / 216 (4.17%)
    4 / 237 (1.69%)
    6 / 231 (2.60%)
         occurrences all number
    6
    12
    5
    6
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    6 / 228 (2.63%)
    10 / 216 (4.63%)
    14 / 237 (5.91%)
    12 / 231 (5.19%)
         occurrences all number
    6
    13
    14
    12
    Pain
    Additional description: Pain
         subjects affected / exposed
    8 / 228 (3.51%)
    4 / 216 (1.85%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences all number
    8
    4
    0
    4
    Papillitis
    Additional description: Papillitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peripheral oedema neonatal
    Additional description: Peripheral oedema neonatal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    4 / 237 (1.69%)
    6 / 231 (2.60%)
         occurrences all number
    3
    2
    4
    7
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    52 / 228 (22.81%)
    45 / 216 (20.83%)
    30 / 237 (12.66%)
    26 / 231 (11.26%)
         occurrences all number
    70
    67
    32
    30
    Swelling
    Additional description: Swelling
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Systemic inflammatory response syndrome
    Additional description: Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Thirst
    Additional description: Thirst
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tissue infiltration
    Additional description: Tissue infiltration
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Anaphylactic reaction
    Additional description: Anaphylactic reaction
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Autoimmune disorder
    Additional description: Autoimmune disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Cytokine release syndrome
    Additional description: Cytokine release syndrome
         subjects affected / exposed
    3 / 228 (1.32%)
    1 / 216 (0.46%)
    4 / 237 (1.69%)
    1 / 231 (0.43%)
         occurrences all number
    4
    1
    4
    1
    Drug hypersensitivity
    Additional description: Drug hypersensitivity
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    10 / 228 (4.39%)
    15 / 216 (6.94%)
    4 / 237 (1.69%)
    5 / 231 (2.16%)
         occurrences all number
    10
    16
    5
    5
    Hypogammaglobulinaemia
    Additional description: Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    0
    1
    1
    2
    Immune reconstitution inflammatory syndrome
    Additional description: Immune reconstitution inflammatory syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Immunodeficiency
    Additional description: Immunodeficiency
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Seasonal allergy
    Additional description: Seasonal allergy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Secondary immunodeficiency
    Additional description: Secondary immunodeficiency
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    1
    1
    Selective IgG subclass deficiency
    Additional description: Selective IgG subclass deficiency
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
    Additional description: Balanoposthitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Benign prostatic hyperplasia
    Additional description: Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    0
    1
    Breast induration
    Additional description: Breast induration
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Breast pain
    Additional description: Breast pain
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    3 / 231 (1.30%)
         occurrences all number
    0
    1
    2
    3
    Dyspareunia
    Additional description: Dyspareunia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Endometriosis
    Additional description: Endometriosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Erectile dysfunction
    Additional description: Erectile dysfunction
         subjects affected / exposed
    2 / 228 (0.88%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    2
    2
    1
    2
    Haematospermia
    Additional description: Haematospermia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Hypomenorrhoea
    Additional description: Hypomenorrhoea
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Menopausal symptoms
    Additional description: Menopausal symptoms
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Menorrhagia
    Additional description: Menorrhagia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Menstruation irregular
    Additional description: Menstruation irregular
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nipple pain
    Additional description: Nipple pain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ovarian hyperfunction
    Additional description: Ovarian hyperfunction
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Penis disorder
    Additional description: Penis disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Pelvic pain
    Additional description: Pelvic pain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Prostatic hypoplasia
    Additional description: Prostatic hypoplasia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Prostatitis
    Additional description: Prostatitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Scrotal oedema
    Additional description: Scrotal oedema
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Testicular disorder
    Additional description: Testicular disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Testicular pain
    Additional description: Testicular pain
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Vaginal haemorrhage
    Additional description: Vaginal haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    0
    1
    0
    3
    Vaginal discharge
    Additional description: Vaginal discharge
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Vulvovaginal pruritus
    Additional description: Vulvovaginal pruritus
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Bronchospasm
    Additional description: Bronchospasm
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Chronic obstructive pulmonary disease
    Additional description: Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    4
    1
    Cough
    Additional description: Cough
         subjects affected / exposed
    37 / 228 (16.23%)
    25 / 216 (11.57%)
    19 / 237 (8.02%)
    37 / 231 (16.02%)
         occurrences all number
    45
    26
    20
    43
    Dysaesthesia pharynx
    Additional description: Dysaesthesia pharynx
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dysphonia
    Additional description: Dysphonia
         subjects affected / exposed
    3 / 228 (1.32%)
    3 / 216 (1.39%)
    4 / 237 (1.69%)
    7 / 231 (3.03%)
         occurrences all number
    3
    4
    5
    7
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    11 / 228 (4.82%)
    14 / 216 (6.48%)
    21 / 237 (8.86%)
    18 / 231 (7.79%)
         occurrences all number
    11
    14
    26
    18
    Dyspnoea exertional
    Additional description: Dyspnoea exertional
         subjects affected / exposed
    3 / 228 (1.32%)
    3 / 216 (1.39%)
    3 / 237 (1.27%)
    3 / 231 (1.30%)
         occurrences all number
    3
    3
    3
    3
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    3 / 228 (1.32%)
    3 / 216 (1.39%)
    4 / 237 (1.69%)
    22 / 231 (9.52%)
         occurrences all number
    3
    3
    5
    27
    Haemoptysis
    Additional description: Haemoptysis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hiccups
    Additional description: Hiccups
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    2
    0
    1
    Hyperventilation
    Additional description: Hyperventilation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    1
    0
    0
    2
    Interstitial lung disease
    Additional description: Interstitial lung disease
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Laryngeal inflammation
    Additional description: Laryngeal inflammation
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Nasal congestion
    Additional description: Nasal congestion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nasal discomfort
    Additional description: Nasal discomfort
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Nasal dryness
    Additional description: Nasal dryness
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Nasal inflammation
    Additional description: Nasal inflammation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal obstruction
    Additional description: Nasal obstruction
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal ulcer
    Additional description: Nasal ulcer
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    13 / 228 (5.70%)
    8 / 216 (3.70%)
    14 / 237 (5.91%)
    14 / 231 (6.06%)
         occurrences all number
    14
    10
    16
    15
    Pharyngeal inflammation
    Additional description: Pharyngeal inflammation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pneumonitis
    Additional description: Pneumonitis
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    2
    1
    Productive cough
    Additional description: Productive cough
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 216 (1.39%)
    4 / 237 (1.69%)
    5 / 231 (2.16%)
         occurrences all number
    2
    3
    4
    6
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    1
    1
    Pulmonary hypertension
    Additional description: Pulmonary hypertension
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pulmonary pain
    Additional description: Pulmonary pain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Rhinitis allergic
    Additional description: Rhinitis allergic
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    3 / 231 (1.30%)
         occurrences all number
    2
    0
    2
    3
    Respiratory alkalosis
    Additional description: Respiratory alkalosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Rhinorrhoea
    Additional description: Rhinorrhoea
         subjects affected / exposed
    3 / 228 (1.32%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    4 / 231 (1.73%)
         occurrences all number
    3
    1
    1
    4
    Sinus pain
    Additional description: Sinus pain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Sleep apnoea syndrome
    Additional description: Sleep apnoea syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tachypnoea
    Additional description: Tachypnoea
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Throat clearing
    Additional description: Throat clearing
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Throat irritation
    Additional description: Throat irritation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences all number
    1
    0
    0
    5
    Throatache
    Additional description: Throatache
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Upper-airway cough syndrome
    Additional description: Upper-airway cough syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wheezing
    Additional description: Wheezing
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Abnormal dreams
    Additional description: Abnormal dreams
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Agitation
    Additional description: Agitation
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    3 / 231 (1.30%)
         occurrences all number
    1
    1
    2
    3
    Aggression
    Additional description: Aggression
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Adjustment disorder
    Additional description: Adjustment disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    3 / 228 (1.32%)
    3 / 216 (1.39%)
    3 / 237 (1.27%)
    2 / 231 (0.87%)
         occurrences all number
    3
    3
    3
    2
    Apathy
    Additional description: Apathy
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bruxism
    Additional description: Bruxism
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Confusional state
    Additional description: Confusional state
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Depression
    Additional description: Depression
         subjects affected / exposed
    2 / 228 (0.88%)
    4 / 216 (1.85%)
    4 / 237 (1.69%)
    7 / 231 (3.03%)
         occurrences all number
    2
    5
    4
    7
    Delirium
    Additional description: Delirium
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Depressed mood
    Additional description: Depressed mood
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Disorientation
    Additional description: Disorientation
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Hallucination
    Additional description: Hallucination
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperarousal
    Additional description: Hyperarousal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Illusion
    Additional description: Illusion
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    7 / 228 (3.07%)
    11 / 216 (5.09%)
    10 / 237 (4.22%)
    10 / 231 (4.33%)
         occurrences all number
    9
    11
    10
    11
    Irritability
    Additional description: Irritability
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    1
    2
    Panic attack
    Additional description: Panic attack
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    2
    1
    Restlessness
    Additional description: Restlessness
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    0
    1
    Sleep disorder
    Additional description: Sleep disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    6 / 237 (2.53%)
    4 / 231 (1.73%)
         occurrences all number
    1
    0
    8
    4
    Somnambulism
    Additional description: Somnambulism
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Stress
    Additional description: Stress
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Activated partial thromboplastin time prolonged
    Additional description: Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
         subjects affected / exposed
    15 / 228 (6.58%)
    1 / 216 (0.46%)
    3 / 237 (1.27%)
    9 / 231 (3.90%)
         occurrences all number
    16
    1
    3
    9
    Amylase increased
    Additional description: Amylase increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aspartate aminotransferase increased
    Additional description: Aspartate aminotransferase increased
         subjects affected / exposed
    10 / 228 (4.39%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    10 / 231 (4.33%)
         occurrences all number
    10
    0
    0
    12
    Blood immunoglobulin G decreased
    Additional description: Blood immunoglobulin G decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    1
    0
    2
    Basophil count decreased
    Additional description: Basophil count decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood alkaline phosphatase increased
    Additional description: Blood alkaline phosphatase increased
         subjects affected / exposed
    4 / 228 (1.75%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    4 / 231 (1.73%)
         occurrences all number
    4
    1
    2
    6
    Blood bilirubin increased
    Additional description: Blood bilirubin increased
         subjects affected / exposed
    4 / 228 (1.75%)
    0 / 216 (0.00%)
    3 / 237 (1.27%)
    9 / 231 (3.90%)
         occurrences all number
    7
    0
    3
    18
    Blood calcium decreased
    Additional description: Blood calcium decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Blood chloride increased
    Additional description: Blood chloride increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Blood creatine increased
    Additional description: Blood creatine increased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    5 / 228 (2.19%)
    7 / 216 (3.24%)
    13 / 237 (5.49%)
    7 / 231 (3.03%)
         occurrences all number
    6
    7
    19
    7
    Blood glucose increased
    Additional description: Blood glucose increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Blood immunoglobulin M decreased
    Additional description: Blood immunoglobulin M decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood lactate dehydrogenase increased
    Additional description: Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    9 / 237 (3.80%)
    4 / 231 (1.73%)
         occurrences all number
    2
    1
    11
    4
    Blood phosphorus increased
    Additional description: Blood phosphorus increased
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    6 / 237 (2.53%)
    9 / 231 (3.90%)
         occurrences all number
    1
    1
    8
    13
    Blood potassium decreased
    Additional description: Blood potassium decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood potassium increased
    Additional description: Blood potassium increased
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    2
    0
    1
    2
    Blood pressure increased
    Additional description: Blood pressure increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Blood thyroid stimulating hormone increased
    Additional description: Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Blood urea increased
    Additional description: Blood urea increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    2
    1
    Blood uric acid decreased
    Additional description: Blood uric acid decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood uric acid increased
    Additional description: Blood uric acid increased
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    5 / 231 (2.16%)
         occurrences all number
    2
    0
    2
    8
    Body temperature increased
    Additional description: Body temperature increased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood iron decreased
    Additional description: Blood iron decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Cardiac murmur
    Additional description: Cardiac murmur
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    0
    1
    Bronchoscopy
    Additional description: Bronchoscopy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    C-reactive protein
    Additional description: C-reactive protein
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    C-reactive protein increased
    Additional description: C-reactive protein increased
         subjects affected / exposed
    2 / 228 (0.88%)
    2 / 216 (0.93%)
    2 / 237 (0.84%)
    5 / 231 (2.16%)
         occurrences all number
    3
    2
    2
    5
    Cortisol decreased
    Additional description: Cortisol decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Enterococcus test positive
    Additional description: Enterococcus test positive
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Eosinophil count decreased
    Additional description: Eosinophil count decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Free haemoglobin present
    Additional description: Free haemoglobin present
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Gamma-glutamyltransferase increased
    Additional description: Gamma-glutamyltransferase increased
         subjects affected / exposed
    6 / 228 (2.63%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    5 / 231 (2.16%)
         occurrences all number
    7
    1
    0
    12
    Glomerular filtration rate decreased
    Additional description: Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Heart rate irregular
    Additional description: Heart rate irregular
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatic enzyme abnormal
    Additional description: Hepatic enzyme abnormal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Hepatic enzyme increased
    Additional description: Hepatic enzyme increased
         subjects affected / exposed
    5 / 228 (2.19%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    5
    0
    2
    2
    Hepatitis B DNA increased
    Additional description: Hepatitis B DNA increased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Immunoglobulins decreased
    Additional description: Immunoglobulins decreased
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Inflammatory marker increased
    Additional description: Inflammatory marker increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    International normalised ratio increased
    Additional description: International normalised ratio increased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Intraocular pressure increased
    Additional description: Intraocular pressure increased
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Left ventricular end-diastolic pressure decreased
    Additional description: Left ventricular end-diastolic pressure decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lipase increased
    Additional description: Lipase increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Liver function test increased
    Additional description: Liver function test increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Monocyte count decreased
    Additional description: Monocyte count decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Myocardial necrosis marker increased
    Additional description: Myocardial necrosis marker increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    N-terminal prohormone brain natriuretic peptide increased
    Additional description: N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Neutrophil count decreased
    Additional description: Neutrophil count decreased
         subjects affected / exposed
    33 / 228 (14.47%)
    22 / 216 (10.19%)
    31 / 237 (13.08%)
    33 / 231 (14.29%)
         occurrences all number
    56
    27
    44
    48
    Platelet count decreased
    Additional description: Platelet count decreased
         subjects affected / exposed
    14 / 228 (6.14%)
    8 / 216 (3.70%)
    8 / 237 (3.38%)
    22 / 231 (9.52%)
         occurrences all number
    19
    9
    8
    31
    Procalcitonin increased
    Additional description: Procalcitonin increased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reticulocyte count decreased
    Additional description: Reticulocyte count decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    SARS-CoV-2 test positive
    Additional description: SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Serum ferritin decreased
    Additional description: Serum ferritin decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Transaminases increased
    Additional description: Transaminases increased
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    0
    1
    Transferrin decreased
    Additional description: Transferrin decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Vitamin B12 decreased
    Additional description: Vitamin B12 decreased
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    0
    1
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    7 / 228 (3.07%)
    6 / 216 (2.78%)
    2 / 237 (0.84%)
    9 / 231 (3.90%)
         occurrences all number
    9
    6
    2
    9
    Weight increased
    Additional description: Weight increased
         subjects affected / exposed
    8 / 228 (3.51%)
    5 / 216 (2.31%)
    6 / 237 (2.53%)
    7 / 231 (3.03%)
         occurrences all number
    8
    9
    6
    7
    White blood cell count decreased
    Additional description: White blood cell count decreased
         subjects affected / exposed
    8 / 228 (3.51%)
    9 / 216 (4.17%)
    5 / 237 (2.11%)
    9 / 231 (3.90%)
         occurrences all number
    13
    9
    8
    18
    White blood cell count increased
    Additional description: White blood cell count increased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
    Additional description: Arthropod bite
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    4 / 237 (1.69%)
    2 / 231 (0.87%)
         occurrences all number
    1
    1
    4
    2
    Animal bite
    Additional description: Animal bite
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Bone contusion
    Additional description: Bone contusion
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Chest injury
    Additional description: Chest injury
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Clavicle fracture
    Additional description: Clavicle fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Contusion
    Additional description: Contusion
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    10 / 231 (4.33%)
         occurrences all number
    1
    1
    1
    11
    Ear canal injury
    Additional description: Ear canal injury
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Epicondylitis
    Additional description: Epicondylitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Face injury
    Additional description: Face injury
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Fall
    Additional description: Fall
         subjects affected / exposed
    5 / 228 (2.19%)
    3 / 216 (1.39%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    5
    4
    0
    2
    Foreign body in eye
    Additional description: Foreign body in eye
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fracture
    Additional description: Fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hand fracture
    Additional description: Hand fracture
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Head injury
    Additional description: Head injury
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Infusion related reaction
    Additional description: Infusion related reaction
         subjects affected / exposed
    101 / 228 (44.30%)
    65 / 216 (30.09%)
    67 / 237 (28.27%)
    46 / 231 (19.91%)
         occurrences all number
    111
    74
    88
    54
    Injury
    Additional description: Injury
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ligament injury
    Additional description: Ligament injury
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Joint capsule rupture
    Additional description: Joint capsule rupture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ligament sprain
    Additional description: Ligament sprain
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Limb injury
    Additional description: Limb injury
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    2
    0
    3
    Mallet finger
    Additional description: Mallet finger
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Meniscus injury
    Additional description: Meniscus injury
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences all number
    0
    0
    0
    4
    Mouth injury
    Additional description: Mouth injury
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Multiple fractures
    Additional description: Multiple fractures
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle strain
    Additional description: Muscle strain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Nasal injury
    Additional description: Nasal injury
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Paravenous drug administration
    Additional description: Paravenous drug administration
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Procedural pain
    Additional description: Procedural pain
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Post-traumatic neck syndrome
    Additional description: Post-traumatic neck syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Road traffic accident
    Additional description: Road traffic accident
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Scar
    Additional description: Scar
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin abrasion
    Additional description: Skin abrasion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    1
    1
    Skin wound
    Additional description: Skin wound
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Spinal compression fracture
    Additional description: Spinal compression fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    6
    Spinal fracture
    Additional description: Spinal fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Tendon rupture
    Additional description: Tendon rupture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Thermal burn
    Additional description: Thermal burn
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Thoracic vertebral fracture
    Additional description: Thoracic vertebral fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Tooth injury
    Additional description: Tooth injury
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Transfusion reaction
    Additional description: Transfusion reaction
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Traumatic ear amputation
    Additional description: Traumatic ear amputation
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Traumatic haematoma
    Additional description: Traumatic haematoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Vascular access complication
    Additional description: Vascular access complication
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Wrist fracture
    Additional description: Wrist fracture
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Wound
    Additional description: Wound
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences all number
    1
    0
    0
    5
    Wound complication
    Additional description: Wound complication
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Congenital, familial and genetic disorders
    Cryptorchism
    Additional description: Cryptorchism
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Glycogen storage disease type I
    Additional description: Glycogen storage disease type I
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hydrocele
    Additional description: Hydrocele
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Ichthyosis
    Additional description: Ichthyosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Phimosis
    Additional description: Phimosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Acute coronary syndrome
    Additional description: Acute coronary syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Angina pectoris
    Additional description: Angina pectoris
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    4 / 237 (1.69%)
    2 / 231 (0.87%)
         occurrences all number
    3
    2
    5
    2
    Arteriosclerosis coronary artery
    Additional description: Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arrhythmia
    Additional description: Arrhythmia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    1
    1
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    5 / 228 (2.19%)
    5 / 216 (2.31%)
    5 / 237 (2.11%)
    17 / 231 (7.36%)
         occurrences all number
    5
    5
    6
    19
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    3
    1
    1
    Atrial thrombosis
    Additional description: Atrial thrombosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Atrioventricular block second degree
    Additional description: Atrioventricular block second degree
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Bundle branch block right
    Additional description: Bundle branch block right
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac discomfort
    Additional description: Cardiac discomfort
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 216 (1.39%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Cardiovascular disorder
    Additional description: Cardiovascular disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    0
    1
    1
    2
    Coronary artery disease
    Additional description: Coronary artery disease
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    0
    1
    Coronary artery stenosis
    Additional description: Coronary artery stenosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Extrasystoles
    Additional description: Extrasystoles
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Hypertensive heart disease
    Additional description: Hypertensive heart disease
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Myocardial ischaemia
    Additional description: Myocardial ischaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    3 / 237 (1.27%)
    10 / 231 (4.33%)
         occurrences all number
    3
    2
    3
    13
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Right ventricular failure
    Additional description: Right ventricular failure
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sinus tachycardia
    Additional description: Sinus tachycardia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Supraventricular tachycardia
    Additional description: Supraventricular tachycardia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Tachycardia
    Additional description: Tachycardia
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    4 / 237 (1.69%)
    3 / 231 (1.30%)
         occurrences all number
    4
    2
    4
    3
    Tachycardia paroxysmal
    Additional description: Tachycardia paroxysmal
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ventricular extrasystoles
    Additional description: Ventricular extrasystoles
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    2
    3
    Nervous system disorders
    Ageusia
    Additional description: Ageusia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Amnesia
    Additional description: Amnesia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    1
    0
    1
    2
    Aphasia
    Additional description: Aphasia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Ataxia
    Additional description: Ataxia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Balance disorder
    Additional description: Balance disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Burning sensation
    Additional description: Burning sensation
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    0
    1
    Carpal tunnel syndrome
    Additional description: Carpal tunnel syndrome
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    4 / 237 (1.69%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    4
    1
    Cervicobrachial syndrome
    Additional description: Cervicobrachial syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Carotid artery stenosis
    Additional description: Carotid artery stenosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Concentration impairment
    Additional description: Concentration impairment
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cognitive disorder
    Additional description: Cognitive disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cubital tunnel syndrome
    Additional description: Cubital tunnel syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Depressed level of consciousness
    Additional description: Depressed level of consciousness
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Disturbance in attention
    Additional description: Disturbance in attention
         subjects affected / exposed
    5 / 228 (2.19%)
    2 / 216 (0.93%)
    3 / 237 (1.27%)
    6 / 231 (2.60%)
         occurrences all number
    5
    2
    3
    6
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    21 / 228 (9.21%)
    12 / 216 (5.56%)
    20 / 237 (8.44%)
    23 / 231 (9.96%)
         occurrences all number
    28
    15
    24
    24
    Dizziness postural
    Additional description: Dizziness postural
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dysaesthesia
    Additional description: Dysaesthesia
         subjects affected / exposed
    2 / 228 (0.88%)
    2 / 216 (0.93%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    2
    2
    2
    1
    Dysgeusia
    Additional description: Dysgeusia
         subjects affected / exposed
    6 / 228 (2.63%)
    9 / 216 (4.17%)
    3 / 237 (1.27%)
    3 / 231 (1.30%)
         occurrences all number
    6
    9
    3
    4
    Facial paralysis
    Additional description: Facial paralysis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Formication
    Additional description: Formication
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hand-arm vibration syndrome
    Additional description: Hand-arm vibration syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Head discomfort
    Additional description: Head discomfort
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Headache
    Additional description: Headache
         subjects affected / exposed
    36 / 228 (15.79%)
    22 / 216 (10.19%)
    23 / 237 (9.70%)
    39 / 231 (16.88%)
         occurrences all number
    45
    29
    26
    52
    Hypoaesthesia
    Additional description: Hypoaesthesia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    2
    1
    Hypertonia
    Additional description: Hypertonia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Hypotonia
    Additional description: Hypotonia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Intention tremor
    Additional description: Intention tremor
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lumbar radiculopathy
    Additional description: Lumbar radiculopathy
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Memory impairment
    Additional description: Memory impairment
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    5 / 231 (2.16%)
         occurrences all number
    1
    0
    2
    5
    Mental impairment
    Additional description: Mental impairment
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Migraine
    Additional description: Migraine
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    3 / 231 (1.30%)
         occurrences all number
    1
    1
    1
    3
    Muscle spasticity
    Additional description: Muscle spasticity
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neuromuscular blockade
    Additional description: Neuromuscular blockade
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Olfactory nerve disorder
    Additional description: Olfactory nerve disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Neuropathy peripheral
    Additional description: Neuropathy peripheral
         subjects affected / exposed
    3 / 228 (1.32%)
    4 / 216 (1.85%)
    1 / 237 (0.42%)
    5 / 231 (2.16%)
         occurrences all number
    3
    4
    1
    6
    Orthostatic intolerance
    Additional description: Orthostatic intolerance
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    3 / 228 (1.32%)
    4 / 216 (1.85%)
    3 / 237 (1.27%)
    9 / 231 (3.90%)
         occurrences all number
    3
    4
    3
    10
    Parkinson's disease
    Additional description: Parkinson's disease
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Parosmia
    Additional description: Parosmia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peripheral motor neuropathy
    Additional description: Peripheral motor neuropathy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Peripheral sensory neuropathy
    Additional description: Peripheral sensory neuropathy
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    5 / 237 (2.11%)
    2 / 231 (0.87%)
         occurrences all number
    4
    2
    5
    2
    Polyneuropathy
    Additional description: Polyneuropathy
         subjects affected / exposed
    3 / 228 (1.32%)
    3 / 216 (1.39%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    3
    4
    2
    1
    Post herpetic neuralgia
    Additional description: Post herpetic neuralgia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Presyncope
    Additional description: Presyncope
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences all number
    0
    2
    0
    5
    Restless legs syndrome
    Additional description: Restless legs syndrome
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences all number
    2
    0
    2
    2
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    1
    1
    0
    2
    Sensory disturbance
    Additional description: Sensory disturbance
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    4 / 228 (1.75%)
    4 / 216 (1.85%)
    2 / 237 (0.84%)
    4 / 231 (1.73%)
         occurrences all number
    4
    4
    2
    4
    Somnolence
    Additional description: Somnolence
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Taste disorder
    Additional description: Taste disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Transient global amnesia
    Additional description: Transient global amnesia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    2
    Tremor
    Additional description: Tremor
         subjects affected / exposed
    3 / 228 (1.32%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    3
    0
    1
    2
    Trigeminal neuralgia
    Additional description: Trigeminal neuralgia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Visual field defect
    Additional description: Visual field defect
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Blood and lymphatic system disorders
    Agranulocytosis
    Additional description: Agranulocytosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    17 / 228 (7.46%)
    31 / 216 (14.35%)
    20 / 237 (8.44%)
    20 / 231 (8.66%)
         occurrences all number
    21
    42
    27
    25
    Autoimmune haemolytic anaemia
    Additional description: Autoimmune haemolytic anaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    2
    Bicytopenia
    Additional description: Bicytopenia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eosinophilia
    Additional description: Eosinophilia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Febrile neutropenia
    Additional description: Febrile neutropenia
         subjects affected / exposed
    2 / 228 (0.88%)
    6 / 216 (2.78%)
    3 / 237 (1.27%)
    2 / 231 (0.87%)
         occurrences all number
    4
    6
    3
    2
    Granulocytopenia
    Additional description: Granulocytopenia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    2
    1
    Haemolysis
    Additional description: Haemolysis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Haemorrhagic diathesis
    Additional description: Haemorrhagic diathesis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Hypoglobulinaemia
    Additional description: Hypoglobulinaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Immune thrombocytopenia
    Additional description: Immune thrombocytopenia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Iron deficiency anaemia
    Additional description: Iron deficiency anaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences all number
    1
    0
    0
    4
    Leukocytosis
    Additional description: Leukocytosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    2
    2
    Leukopenia
    Additional description: Leukopenia
         subjects affected / exposed
    20 / 228 (8.77%)
    33 / 216 (15.28%)
    12 / 237 (5.06%)
    17 / 231 (7.36%)
         occurrences all number
    30
    48
    22
    27
    Lymph node pain
    Additional description: Lymph node pain
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    1
    0
    1
    Lymphadenitis
    Additional description: Lymphadenitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lymphadenopathy
    Additional description: Lymphadenopathy
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Macrocytosis
    Additional description: Macrocytosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Microcytic anaemia
    Additional description: Microcytic anaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    111 / 228 (48.68%)
    107 / 216 (49.54%)
    108 / 237 (45.57%)
    110 / 231 (47.62%)
         occurrences all number
    272
    209
    231
    237
    Pancytopenia
    Additional description: Pancytopenia
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    2
    0
    2
    Reticulocytosis
    Additional description: Reticulocytosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    34 / 228 (14.91%)
    32 / 216 (14.81%)
    18 / 237 (7.59%)
    52 / 231 (22.51%)
         occurrences all number
    40
    44
    28
    77
    Ear and labyrinth disorders
    Auditory disorder
    Additional description: Auditory disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Deafness
    Additional description: Deafness
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences all number
    1
    0
    0
    4
    Deafness unilateral
    Additional description: Deafness unilateral
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear haemorrhage
    Additional description: Ear haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 216 (1.39%)
    3 / 237 (1.27%)
    4 / 231 (1.73%)
         occurrences all number
    1
    3
    3
    4
    Hypoacusis
    Additional description: Hypoacusis
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    2
    1
    0
    2
    Middle ear effusion
    Additional description: Middle ear effusion
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Middle ear inflammation
    Additional description: Middle ear inflammation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Tinnitus
    Additional description: Tinnitus
         subjects affected / exposed
    6 / 228 (2.63%)
    0 / 216 (0.00%)
    4 / 237 (1.69%)
    3 / 231 (1.30%)
         occurrences all number
    6
    0
    4
    3
    Vertigo positional
    Additional description: Vertigo positional
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    6 / 228 (2.63%)
    8 / 216 (3.70%)
    9 / 237 (3.80%)
    10 / 231 (4.33%)
         occurrences all number
    6
    8
    9
    12
    Eye disorders
    Blepharitis
    Additional description: Blepharitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Cataract
    Additional description: Cataract
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    1
    1
    Conjunctival haemorrhage
    Additional description: Conjunctival haemorrhage
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    2
    0
    0
    2
    Corneal erosion
    Additional description: Corneal erosion
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diplopia
    Additional description: Diplopia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Dry eye
    Additional description: Dry eye
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    6 / 231 (2.60%)
         occurrences all number
    1
    2
    1
    6
    Erythema of eyelid
    Additional description: Erythema of eyelid
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Exophthalmos
    Additional description: Exophthalmos
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye haemorrhage
    Additional description: Eye haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    2
    1
    Eye inflammation
    Additional description: Eye inflammation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Eye irritation
    Additional description: Eye irritation
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    2
    0
    2
    Eye oedema
    Additional description: Eye oedema
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Eye pain
    Additional description: Eye pain
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eyelid haematoma
    Additional description: Eyelid haematoma
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Eyelid oedema
    Additional description: Eyelid oedema
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eyelid ptosis
    Additional description: Eyelid ptosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Eye disorder
    Additional description: Eye disorder
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Glaucoma
    Additional description: Glaucoma
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hyalosis asteroid
    Additional description: Hyalosis asteroid
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lacrimation increased
    Additional description: Lacrimation increased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Ocular hyperaemia
    Additional description: Ocular hyperaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    0
    1
    1
    2
    Ocular hypertension
    Additional description: Ocular hypertension
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Panophthalmitis
    Additional description: Panophthalmitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Periorbital oedema
    Additional description: Periorbital oedema
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Photophobia
    Additional description: Photophobia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Retinal haemorrhage
    Additional description: Retinal haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Uveitis
    Additional description: Uveitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Vitreous detachment
    Additional description: Vitreous detachment
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vitreous disorder
    Additional description: Vitreous disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vitreous haemorrhage
    Additional description: Vitreous haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Visual impairment
    Additional description: Visual impairment
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    3 / 237 (1.27%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    3
    0
    Vision blurred
    Additional description: Vision blurred
         subjects affected / exposed
    4 / 228 (1.75%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    7 / 231 (3.03%)
         occurrences all number
    4
    0
    1
    7
    Gastrointestinal disorders
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    11 / 228 (4.82%)
    8 / 216 (3.70%)
    11 / 237 (4.64%)
    21 / 231 (9.09%)
         occurrences all number
    12
    8
    12
    23
    Abdominal pain lower
    Additional description: Abdominal pain lower
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 216 (1.39%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    1
    3
    0
    3
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    6 / 228 (2.63%)
    5 / 216 (2.31%)
    14 / 237 (5.91%)
    15 / 231 (6.49%)
         occurrences all number
    6
    6
    17
    15
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    3 / 228 (1.32%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    3
    1
    0
    3
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    4 / 237 (1.69%)
    6 / 231 (2.60%)
         occurrences all number
    3
    2
    4
    7
    Anal ulcer
    Additional description: Anal ulcer
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Anal pruritus
    Additional description: Anal pruritus
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Anal incontinence
    Additional description: Anal incontinence
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Anal haemorrhage
    Additional description: Anal haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    1
    2
    Anal fissure
    Additional description: Anal fissure
         subjects affected / exposed
    0 / 228 (0.00%)
    3 / 216 (1.39%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    3
    0
    2
    Angular cheilitis
    Additional description: Angular cheilitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Aphthous ulcer
    Additional description: Aphthous ulcer
         subjects affected / exposed
    3 / 228 (1.32%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    3 / 231 (1.30%)
         occurrences all number
    3
    0
    2
    3
    Cheilitis
    Additional description: Cheilitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Coeliac disease
    Additional description: Coeliac disease
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Colitis
    Additional description: Colitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    28 / 228 (12.28%)
    64 / 216 (29.63%)
    28 / 237 (11.81%)
    29 / 231 (12.55%)
         occurrences all number
    31
    73
    31
    32
    Crohn's disease
    Additional description: Crohn's disease
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dental caries
    Additional description: Dental caries
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    74 / 228 (32.46%)
    27 / 216 (12.50%)
    72 / 237 (30.38%)
    118 / 231 (51.08%)
         occurrences all number
    108
    31
    97
    177
    Diarrhoea haemorrhagic
    Additional description: Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Defaecation disorder
    Additional description: Defaecation disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diverticulum intestinal
    Additional description: Diverticulum intestinal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dry mouth
    Additional description: Dry mouth
         subjects affected / exposed
    3 / 228 (1.32%)
    5 / 216 (2.31%)
    2 / 237 (0.84%)
    10 / 231 (4.33%)
         occurrences all number
    3
    5
    2
    10
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    17 / 228 (7.46%)
    3 / 216 (1.39%)
    10 / 237 (4.22%)
    27 / 231 (11.69%)
         occurrences all number
    19
    3
    10
    28
    Dysphagia
    Additional description: Dysphagia
         subjects affected / exposed
    2 / 228 (0.88%)
    3 / 216 (1.39%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences all number
    2
    3
    2
    2
    Enterovirus infection
    Additional description: Enterovirus infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Epigastric discomfort
    Additional description: Epigastric discomfort
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    3 / 237 (1.27%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Faeces discoloured
    Additional description: Faeces discoloured
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastric haemorrhage
    Additional description: Gastric haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    9 / 228 (3.95%)
    3 / 216 (1.39%)
    4 / 237 (1.69%)
    8 / 231 (3.46%)
         occurrences all number
    11
    3
    4
    8
    Food poisoning
    Additional description: Food poisoning
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Frequent bowel movements
    Additional description: Frequent bowel movements
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Giant cell epulis
    Additional description: Giant cell epulis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Gingival bleeding
    Additional description: Gingival bleeding
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    2
    1
    0
    2
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    3 / 231 (1.30%)
         occurrences all number
    1
    1
    1
    3
    Gastrointestinal haemorrhage
    Additional description: Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal motility disorder
    Additional description: Gastrointestinal motility disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal pain
    Additional description: Gastrointestinal pain
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Gastrointestinal tract irritation
    Additional description: Gastrointestinal tract irritation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 228 (0.88%)
    5 / 216 (2.31%)
    9 / 237 (3.80%)
    8 / 231 (3.46%)
         occurrences all number
    2
    5
    9
    8
    Gingival discolouration
    Additional description: Gingival discolouration
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Haemorrhoidal haemorrhage
    Additional description: Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haematochezia
    Additional description: Haematochezia
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    1
    1
    Haemorrhoids
    Additional description: Haemorrhoids
         subjects affected / exposed
    4 / 228 (1.75%)
    1 / 216 (0.46%)
    3 / 237 (1.27%)
    3 / 231 (1.30%)
         occurrences all number
    4
    1
    3
    3
    Inguinal hernia
    Additional description: Inguinal hernia
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    2
    1
    Lip dry
    Additional description: Lip dry
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Lip pain
    Additional description: Lip pain
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mouth haemorrhage
    Additional description: Mouth haemorrhage
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Mouth ulceration
    Additional description: Mouth ulceration
         subjects affected / exposed
    2 / 228 (0.88%)
    2 / 216 (0.93%)
    3 / 237 (1.27%)
    2 / 231 (0.87%)
         occurrences all number
    2
    2
    6
    2
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    69 / 228 (30.26%)
    93 / 216 (43.06%)
    64 / 237 (27.00%)
    77 / 231 (33.33%)
         occurrences all number
    87
    132
    86
    100
    Odynophagia
    Additional description: Odynophagia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Oesophagitis
    Additional description: Oesophagitis
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    2
    0
    2
    1
    Oral dysaesthesia
    Additional description: Oral dysaesthesia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Oral mucosal blistering
    Additional description: Oral mucosal blistering
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    3 / 231 (1.30%)
         occurrences all number
    0
    0
    1
    3
    Oral mucosal erythema
    Additional description: Oral mucosal erythema
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oral pain
    Additional description: Oral pain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    3
    Paraesthesia oral
    Additional description: Paraesthesia oral
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Periodontal disease
    Additional description: Periodontal disease
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Proctalgia
    Additional description: Proctalgia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rectal haemorrhage
    Additional description: Rectal haemorrhage
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    1
    0
    1
    2
    Rectal polyp
    Additional description: Rectal polyp
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Salivary gland calculus
    Additional description: Salivary gland calculus
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    6 / 228 (2.63%)
    3 / 216 (1.39%)
    3 / 237 (1.27%)
    12 / 231 (5.19%)
         occurrences all number
    6
    3
    5
    14
    Tongue coated
    Additional description: Tongue coated
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tongue discomfort
    Additional description: Tongue discomfort
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Tongue disorder
    Additional description: Tongue disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Tongue dry
    Additional description: Tongue dry
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Tooth loss
    Additional description: Tooth loss
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Toothache
    Additional description: Toothache
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    4 / 237 (1.69%)
    6 / 231 (2.60%)
         occurrences all number
    1
    0
    4
    6
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    14 / 228 (6.14%)
    40 / 216 (18.52%)
    16 / 237 (6.75%)
    24 / 231 (10.39%)
         occurrences all number
    17
    55
    21
    36
    Hepatobiliary disorders
    Cholecystitis
    Additional description: Cholecystitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatic pain
    Additional description: Hepatic pain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatic steatosis
    Additional description: Hepatic steatosis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatotoxicity
    Additional description: Hepatotoxicity
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hyperbilirubinaemia
    Additional description: Hyperbilirubinaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Liver disorder
    Additional description: Liver disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Portal vein dilatation
    Additional description: Portal vein dilatation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Portal vein thrombosis
    Additional description: Portal vein thrombosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
    Additional description: Actinic keratosis
         subjects affected / exposed
    5 / 228 (2.19%)
    0 / 216 (0.00%)
    5 / 237 (2.11%)
    3 / 231 (1.30%)
         occurrences all number
    5
    0
    5
    3
    Alopecia
    Additional description: Alopecia
         subjects affected / exposed
    2 / 228 (0.88%)
    4 / 216 (1.85%)
    6 / 237 (2.53%)
    4 / 231 (1.73%)
         occurrences all number
    2
    4
    6
    4
    Blister
    Additional description: Blister
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    1
    1
    Blood blister
    Additional description: Blood blister
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Cafe au lait spots
    Additional description: Cafe au lait spots
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis
    Additional description: Dermatitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    2
    1
    Dermatitis acneiform
    Additional description: Dermatitis acneiform
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    2
    0
    1
    Dermatitis allergic
    Additional description: Dermatitis allergic
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    3
    0
    1
    Dermatitis atopic
    Additional description: Dermatitis atopic
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dermatitis contact
    Additional description: Dermatitis contact
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis exfoliative
    Additional description: Dermatitis exfoliative
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Dermatitis exfoliative generalised
    Additional description: Dermatitis exfoliative generalised
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Decubitus ulcer
    Additional description: Decubitus ulcer
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Drug eruption
    Additional description: Drug eruption
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Dry skin
    Additional description: Dry skin
         subjects affected / exposed
    16 / 228 (7.02%)
    8 / 216 (3.70%)
    8 / 237 (3.38%)
    17 / 231 (7.36%)
         occurrences all number
    18
    8
    8
    17
    Ecchymosis
    Additional description: Ecchymosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    5 / 231 (2.16%)
         occurrences all number
    0
    0
    0
    6
    Eczema
    Additional description: Eczema
         subjects affected / exposed
    5 / 228 (2.19%)
    3 / 216 (1.39%)
    13 / 237 (5.49%)
    12 / 231 (5.19%)
         occurrences all number
    5
    3
    13
    12
    Eczema nummular
    Additional description: Eczema nummular
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    6 / 228 (2.63%)
    3 / 216 (1.39%)
    3 / 237 (1.27%)
    4 / 231 (1.73%)
         occurrences all number
    7
    4
    4
    4
    Erythema nodosum
    Additional description: Erythema nodosum
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Eosinophilic cellulitis
    Additional description: Eosinophilic cellulitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Erythema multiforme
    Additional description: Erythema multiforme
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    0
    0
    0
    3
    Hand dermatitis
    Additional description: Hand dermatitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Hyperkeratosis
    Additional description: Hyperkeratosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    1
    2
    Hyperhidrosis
    Additional description: Hyperhidrosis
         subjects affected / exposed
    7 / 228 (3.07%)
    3 / 216 (1.39%)
    3 / 237 (1.27%)
    6 / 231 (2.60%)
         occurrences all number
    8
    3
    3
    6
    Hypertrichosis
    Additional description: Hypertrichosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Intertrigo
    Additional description: Intertrigo
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lentigo
    Additional description: Lentigo
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lichen planus
    Additional description: Lichen planus
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Neurodermatitis
    Additional description: Neurodermatitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nail discolouration
    Additional description: Nail discolouration
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nail dystrophy
    Additional description: Nail dystrophy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Nail pitting
    Additional description: Nail pitting
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nail ridging
    Additional description: Nail ridging
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Nail toxicity
    Additional description: Nail toxicity
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Night sweats
    Additional description: Night sweats
         subjects affected / exposed
    7 / 228 (3.07%)
    8 / 216 (3.70%)
    4 / 237 (1.69%)
    4 / 231 (1.73%)
         occurrences all number
    7
    9
    4
    4
    Onychoclasis
    Additional description: Onychoclasis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    6 / 231 (2.60%)
         occurrences all number
    0
    1
    2
    6
    Onycholysis
    Additional description: Onycholysis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Papule
    Additional description: Papule
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pemphigoid
    Additional description: Pemphigoid
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Petechiae
    Additional description: Petechiae
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    12 / 231 (5.19%)
         occurrences all number
    1
    1
    0
    17
    Pigmentation disorder
    Additional description: Pigmentation disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Rash generalised
    Additional description: Rash generalised
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash erythematous
    Additional description: Rash erythematous
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    15 / 228 (6.58%)
    17 / 216 (7.87%)
    19 / 237 (8.02%)
    17 / 231 (7.36%)
         occurrences all number
    16
    17
    20
    17
    Pruritus generalised
    Additional description: Pruritus generalised
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psoriasis
    Additional description: Psoriasis
         subjects affected / exposed
    4 / 228 (1.75%)
    2 / 216 (0.93%)
    3 / 237 (1.27%)
    2 / 231 (0.87%)
         occurrences all number
    4
    2
    3
    3
    Purpura
    Additional description: Purpura
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Rash
    Additional description: Rash
         subjects affected / exposed
    27 / 228 (11.84%)
    33 / 216 (15.28%)
    32 / 237 (13.50%)
    37 / 231 (16.02%)
         occurrences all number
    29
    38
    36
    49
    Rash macular
    Additional description: Rash macular
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash maculo-papular
    Additional description: Rash maculo-papular
         subjects affected / exposed
    3 / 228 (1.32%)
    10 / 216 (4.63%)
    8 / 237 (3.38%)
    9 / 231 (3.90%)
         occurrences all number
    3
    14
    9
    12
    Rash pruritic
    Additional description: Rash pruritic
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Rash papular
    Additional description: Rash papular
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rosacea
    Additional description: Rosacea
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    1
    1
    Solar dermatitis
    Additional description: Solar dermatitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin burning sensation
    Additional description: Skin burning sensation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin discolouration
    Additional description: Skin discolouration
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Skin discomfort
    Additional description: Skin discomfort
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Skin disorder
    Additional description: Skin disorder
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Skin fissures
    Additional description: Skin fissures
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    1
    0
    0
    3
    Skin hypopigmentation
    Additional description: Skin hypopigmentation
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin irritation
    Additional description: Skin irritation
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin lesion
    Additional description: Skin lesion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    4 / 231 (1.73%)
         occurrences all number
    1
    0
    1
    4
    Skin mass
    Additional description: Skin mass
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Skin ulcer
    Additional description: Skin ulcer
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    0
    1
    0
    3
    Suggillation
    Additional description: Suggillation
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Telangiectasia
    Additional description: Telangiectasia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Toxic skin eruption
    Additional description: Toxic skin eruption
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Urticaria
    Additional description: Urticaria
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 216 (1.39%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    1
    3
    3
    2
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences all number
    2
    1
    2
    2
    Chromaturia
    Additional description: Chromaturia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Chronic kidney disease
    Additional description: Chronic kidney disease
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cystitis noninfective
    Additional description: Cystitis noninfective
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    2 / 228 (0.88%)
    6 / 216 (2.78%)
    1 / 237 (0.42%)
    3 / 231 (1.30%)
         occurrences all number
    4
    6
    1
    3
    Haematuria
    Additional description: Haematuria
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    2 / 237 (0.84%)
    8 / 231 (3.46%)
         occurrences all number
    1
    2
    2
    8
    Hydronephrosis
    Additional description: Hydronephrosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Incontinence
    Additional description: Incontinence
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Kidney congestion
    Additional description: Kidney congestion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Leukocyturia
    Additional description: Leukocyturia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lower urinary tract symptoms
    Additional description: Lower urinary tract symptoms
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Micturition disorder
    Additional description: Micturition disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Micturition urgency
    Additional description: Micturition urgency
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Nocturia
    Additional description: Nocturia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    4 / 237 (1.69%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    4
    1
    Pollakiuria
    Additional description: Pollakiuria
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences all number
    3
    2
    2
    2
    Polyuria
    Additional description: Polyuria
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal colic
    Additional description: Renal colic
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Renal cyst
    Additional description: Renal cyst
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Renal pain
    Additional description: Renal pain
         subjects affected / exposed
    0 / 228 (0.00%)
    3 / 216 (1.39%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Strangury
    Additional description: Strangury
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract pain
    Additional description: Urinary tract pain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Urinary tract obstruction
    Additional description: Urinary tract obstruction
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Urinary tract inflammation
    Additional description: Urinary tract inflammation
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences all number
    3
    1
    2
    2
    Urge incontinence
    Additional description: Urge incontinence
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Endocrine disorders
    Goitre
    Additional description: Goitre
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Hyperthyroidism
    Additional description: Hyperthyroidism
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypothyroidism
    Additional description: Hypothyroidism
         subjects affected / exposed
    3 / 228 (1.32%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Thyroid cyst
    Additional description: Thyroid cyst
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthropathy
    Additional description: Arthropathy
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Arthritis
    Additional description: Arthritis
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    4 / 237 (1.69%)
    7 / 231 (3.03%)
         occurrences all number
    4
    3
    5
    9
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    33 / 228 (14.47%)
    8 / 216 (3.70%)
    25 / 237 (10.55%)
    44 / 231 (19.05%)
         occurrences all number
    42
    8
    26
    53
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    24 / 228 (10.53%)
    12 / 216 (5.56%)
    26 / 237 (10.97%)
    28 / 231 (12.12%)
         occurrences all number
    26
    13
    27
    31
    Bone pain
    Additional description: Bone pain
         subjects affected / exposed
    10 / 228 (4.39%)
    2 / 216 (0.93%)
    6 / 237 (2.53%)
    5 / 231 (2.16%)
         occurrences all number
    10
    2
    6
    5
    Bursal haematoma
    Additional description: Bursal haematoma
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    4 / 228 (1.75%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    4
    0
    0
    1
    Cervical spinal stenosis
    Additional description: Cervical spinal stenosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Exostosis
    Additional description: Exostosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fibromyalgia
    Additional description: Fibromyalgia
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Flank pain
    Additional description: Flank pain
         subjects affected / exposed
    4 / 228 (1.75%)
    3 / 216 (1.39%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    4
    3
    1
    2
    Groin pain
    Additional description: Groin pain
         subjects affected / exposed
    3 / 228 (1.32%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Hypercreatinaemia
    Additional description: Hypercreatinaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Intervertebral disc disorder
    Additional description: Intervertebral disc disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Joint effusion
    Additional description: Joint effusion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    1
    0
    0
    3
    Joint range of motion decreased
    Additional description: Joint range of motion decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Joint swelling
    Additional description: Joint swelling
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    3 / 237 (1.27%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    4
    2
    Limb discomfort
    Additional description: Limb discomfort
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Mobility decreased
    Additional description: Mobility decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Muscle fatigue
    Additional description: Muscle fatigue
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Muscle hypertrophy
    Additional description: Muscle hypertrophy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    6 / 228 (2.63%)
    5 / 216 (2.31%)
    10 / 237 (4.22%)
    21 / 231 (9.09%)
         occurrences all number
    7
    5
    11
    24
    Muscle tightness
    Additional description: Muscle tightness
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Muscle twitching
    Additional description: Muscle twitching
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Muscular weakness
    Additional description: Muscular weakness
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    2
    1
    0
    3
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    5 / 231 (2.16%)
         occurrences all number
    1
    1
    0
    5
    Musculoskeletal discomfort
    Additional description: Musculoskeletal discomfort
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    8 / 228 (3.51%)
    3 / 216 (1.39%)
    12 / 237 (5.06%)
    8 / 231 (3.46%)
         occurrences all number
    8
    3
    12
    8
    Musculoskeletal stiffness
    Additional description: Musculoskeletal stiffness
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    3 / 237 (1.27%)
    1 / 231 (0.43%)
         occurrences all number
    2
    1
    3
    1
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    16 / 228 (7.02%)
    9 / 216 (4.17%)
    18 / 237 (7.59%)
    15 / 231 (6.49%)
         occurrences all number
    17
    13
    19
    16
    Neck pain
    Additional description: Neck pain
         subjects affected / exposed
    5 / 228 (2.19%)
    1 / 216 (0.46%)
    5 / 237 (2.11%)
    3 / 231 (1.30%)
         occurrences all number
    5
    1
    5
    3
    Myositis
    Additional description: Myositis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    3 / 228 (1.32%)
    0 / 216 (0.00%)
    4 / 237 (1.69%)
    3 / 231 (1.30%)
         occurrences all number
    3
    0
    4
    3
    Osteonecrosis
    Additional description: Osteonecrosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Osteoporosis
    Additional description: Osteoporosis
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    1
    0
    1
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    9 / 228 (3.95%)
    4 / 216 (1.85%)
    12 / 237 (5.06%)
    7 / 231 (3.03%)
         occurrences all number
    9
    6
    13
    7
    Pain in jaw
    Additional description: Pain in jaw
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Periarthritis
    Additional description: Periarthritis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    2
    Polyarthritis
    Additional description: Polyarthritis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Polymyalgia rheumatica
    Additional description: Polymyalgia rheumatica
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psoriatic arthropathy
    Additional description: Psoriatic arthropathy
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Rheumatic disorder
    Additional description: Rheumatic disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Spinal column stenosis
    Additional description: Spinal column stenosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Spinal pain
    Additional description: Spinal pain
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences all number
    2
    1
    0
    4
    Tendon disorder
    Additional description: Tendon disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tendonitis
    Additional description: Tendonitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    1
    1
    Vertebral foraminal stenosis
    Additional description: Vertebral foraminal stenosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Infections and infestations
    Abscess limb
    Additional description: Abscess limb
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Abdominal infection
    Additional description: Abdominal infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Acarodermatitis
    Additional description: Acarodermatitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Abscess
    Additional description: Abscess
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    2
    1
    0
    2
    Acute sinusitis
    Additional description: Acute sinusitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    2
    Atypical pneumonia
    Additional description: Atypical pneumonia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bacterial blepharitis
    Additional description: Bacterial blepharitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bacterial food poisoning
    Additional description: Bacterial food poisoning
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bacterial infection
    Additional description: Bacterial infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Asymptomatic COVID-19
    Additional description: Asymptomatic COVID-19
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bacterial prostatitis
    Additional description: Bacterial prostatitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bacteriuria
    Additional description: Bacteriuria
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Body tinea
    Additional description: Body tinea
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Borrelia infection
    Additional description: Borrelia infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Bronchitis bacterial
    Additional description: Bronchitis bacterial
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Bronchopulmonary aspergillosis
    Additional description: Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bursitis infective
    Additional description: Bursitis infective
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Campylobacter gastroenteritis
    Additional description: Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Candida infection
    Additional description: Candida infection
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    1
    1
    0
    3
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    17 / 228 (7.46%)
    19 / 216 (8.80%)
    23 / 237 (9.70%)
    27 / 231 (11.69%)
         occurrences all number
    22
    19
    24
    29
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    3 / 237 (1.27%)
    3 / 231 (1.30%)
         occurrences all number
    2
    1
    3
    4
    Chronic sinusitis
    Additional description: Chronic sinusitis
         subjects affected / exposed
    2 / 228 (0.88%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    2
    2
    1
    3
    Clostridium difficile colitis
    Additional description: Clostridium difficile colitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Clostridium difficile infection
    Additional description: Clostridium difficile infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Conjunctivitis
    Additional description: Conjunctivitis
         subjects affected / exposed
    8 / 228 (3.51%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    17 / 231 (7.36%)
         occurrences all number
    10
    3
    1
    22
    COVID-19
    Additional description: COVID-19
         subjects affected / exposed
    37 / 228 (16.23%)
    35 / 216 (16.20%)
    36 / 237 (15.19%)
    42 / 231 (18.18%)
         occurrences all number
    42
    36
    41
    48
    COVID-19 pneumonia
    Additional description: COVID-19 pneumonia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    6 / 228 (2.63%)
    7 / 216 (3.24%)
    8 / 237 (3.38%)
    11 / 231 (4.76%)
         occurrences all number
    9
    8
    11
    22
    Cytomegalovirus infection
    Additional description: Cytomegalovirus infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dacryocanaliculitis
    Additional description: Dacryocanaliculitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dacryocystitis
    Additional description: Dacryocystitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Device related infection
    Additional description: Device related infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Dengue fever
    Additional description: Dengue fever
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diverticulitis
    Additional description: Diverticulitis
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    2
    1
    0
    3
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    2 / 228 (0.88%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    6 / 231 (2.60%)
         occurrences all number
    2
    2
    1
    8
    Ear infection bacterial
    Additional description: Ear infection bacterial
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Erythema migrans
    Additional description: Erythema migrans
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    2
    0
    1
    Enterococcal infection
    Additional description: Enterococcal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Enterococcal sepsis
    Additional description: Enterococcal sepsis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epididymitis
    Additional description: Epididymitis
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences all number
    3
    0
    3
    2
    Erysipelas
    Additional description: Erysipelas
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    3 / 237 (1.27%)
    5 / 231 (2.16%)
         occurrences all number
    1
    0
    3
    6
    Eye infection
    Additional description: Eye infection
         subjects affected / exposed
    7 / 228 (3.07%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    3 / 231 (1.30%)
         occurrences all number
    8
    0
    2
    3
    Eyelid infection
    Additional description: Eyelid infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Febrile infection
    Additional description: Febrile infection
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 216 (1.39%)
    1 / 237 (0.42%)
    5 / 231 (2.16%)
         occurrences all number
    1
    3
    1
    5
    Folliculitis
    Additional description: Folliculitis
         subjects affected / exposed
    4 / 228 (1.75%)
    2 / 216 (0.93%)
    2 / 237 (0.84%)
    3 / 231 (1.30%)
         occurrences all number
    4
    2
    4
    3
    Fungal infection
    Additional description: Fungal infection
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 216 (1.39%)
    2 / 237 (0.84%)
    1 / 231 (0.43%)
         occurrences all number
    1
    3
    2
    1
    Fungal skin infection
    Additional description: Fungal skin infection
         subjects affected / exposed
    2 / 228 (0.88%)
    3 / 216 (1.39%)
    1 / 237 (0.42%)
    3 / 231 (1.30%)
         occurrences all number
    2
    3
    1
    3
    Furuncle
    Additional description: Furuncle
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    0
    0
    0
    4
    Genital infection fungal
    Additional description: Genital infection fungal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Genital herpes
    Additional description: Genital herpes
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Giardiasis
    Additional description: Giardiasis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastric infection
    Additional description: Gastric infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    3 / 228 (1.32%)
    6 / 216 (2.78%)
    5 / 237 (2.11%)
    8 / 231 (3.46%)
         occurrences all number
    3
    6
    5
    8
    Gastroenteritis caliciviral
    Additional description: Gastroenteritis caliciviral
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastroenteritis viral
    Additional description: Gastroenteritis viral
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 216 (1.39%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Gastrointestinal disorders
    Additional description: Gastrointestinal disorders
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal infection
    Additional description: Gastrointestinal infection
         subjects affected / exposed
    4 / 228 (1.75%)
    2 / 216 (0.93%)
    3 / 237 (1.27%)
    2 / 231 (0.87%)
         occurrences all number
    4
    2
    3
    2
    Haemophilus infection
    Additional description: Haemophilus infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    1
    1
    Gingivitis
    Additional description: Gingivitis
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 216 (1.39%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences all number
    1
    3
    2
    3
    Herpes infection
    Additional description: Herpes infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Helicobacter gastritis
    Additional description: Helicobacter gastritis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    3 / 237 (1.27%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Hepatitis B reactivation
    Additional description: Hepatitis B reactivation
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    2
    1
    1
    1
    Hepatitis E
    Additional description: Hepatitis E
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatitis viral
    Additional description: Hepatitis viral
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Herpes dermatitis
    Additional description: Herpes dermatitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Herpes simplex
    Additional description: Herpes simplex
         subjects affected / exposed
    6 / 228 (2.63%)
    0 / 216 (0.00%)
    4 / 237 (1.69%)
    5 / 231 (2.16%)
         occurrences all number
    9
    0
    5
    5
    Herpes simplex reactivation
    Additional description: Herpes simplex reactivation
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hordeolum
    Additional description: Hordeolum
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    1
    1
    1
    2
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    9 / 228 (3.95%)
    21 / 216 (9.72%)
    13 / 237 (5.49%)
    8 / 231 (3.46%)
         occurrences all number
    9
    24
    13
    8
    Herpes virus infection
    Additional description: Herpes virus infection
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    3 / 237 (1.27%)
    2 / 231 (0.87%)
         occurrences all number
    5
    3
    3
    2
    Herpes viral infections
    Additional description: Herpes viral infections
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infection
    Additional description: Infection
         subjects affected / exposed
    14 / 228 (6.14%)
    20 / 216 (9.26%)
    7 / 237 (2.95%)
    9 / 231 (3.90%)
         occurrences all number
    17
    26
    11
    10
    Infection susceptibility increased
    Additional description: Infection susceptibility increased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infectious colitis
    Additional description: Infectious colitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Infective iritis
    Additional description: Infective iritis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Impetigo
    Additional description: Impetigo
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    0
    0
    0
    3
    Infected bite
    Additional description: Infected bite
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Infected dermal cyst
    Additional description: Infected dermal cyst
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infected skin ulcer
    Additional description: Infected skin ulcer
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Injection site cellulitis
    Additional description: Injection site cellulitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    9 / 228 (3.95%)
    9 / 216 (4.17%)
    7 / 237 (2.95%)
    7 / 231 (3.03%)
         occurrences all number
    10
    10
    8
    8
    Joint abscess
    Additional description: Joint abscess
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Kidney infection
    Additional description: Kidney infection
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Labyrinthitis
    Additional description: Labyrinthitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Laryngitis
    Additional description: Laryngitis
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    3 / 231 (1.30%)
         occurrences all number
    1
    1
    1
    3
    Lip infection
    Additional description: Lip infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Localised infection
    Additional description: Localised infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    1
    2
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    3 / 228 (1.32%)
    4 / 216 (1.85%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    4
    5
    1
    5
    Lyme disease
    Additional description: Lyme disease
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    3 / 237 (1.27%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Lymph gland infection
    Additional description: Lymph gland infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Metapneumovirus infection
    Additional description: Metapneumovirus infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Mucosal infection
    Additional description: Mucosal infection
         subjects affected / exposed
    3 / 228 (1.32%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    2 / 231 (0.87%)
         occurrences all number
    3
    2
    1
    2
    Nail infection
    Additional description: Nail infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    0
    0
    0
    3
    Nasal candidiasis
    Additional description: Nasal candidiasis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    70 / 228 (30.70%)
    44 / 216 (20.37%)
    55 / 237 (23.21%)
    46 / 231 (19.91%)
         occurrences all number
    99
    61
    81
    68
    Onychomycosis
    Additional description: Onychomycosis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    2 / 231 (0.87%)
         occurrences all number
    1
    0
    2
    2
    Neutropenic infection
    Additional description: Neutropenic infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Omphalitis
    Additional description: Omphalitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Ophthalmic herpes zoster
    Additional description: Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Oral candidiasis
    Additional description: Oral candidiasis
         subjects affected / exposed
    1 / 228 (0.44%)
    6 / 216 (2.78%)
    7 / 237 (2.95%)
    1 / 231 (0.43%)
         occurrences all number
    1
    6
    8
    1
    Oral fungal infection
    Additional description: Oral fungal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Oral herpes
    Additional description: Oral herpes
         subjects affected / exposed
    12 / 228 (5.26%)
    9 / 216 (4.17%)
    14 / 237 (5.91%)
    8 / 231 (3.46%)
         occurrences all number
    12
    12
    16
    8
    Oral infection
    Additional description: Oral infection
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    0
    1
    Oropharyngeal candidiasis
    Additional description: Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Osteomyelitis
    Additional description: Osteomyelitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Otitis media
    Additional description: Otitis media
         subjects affected / exposed
    5 / 228 (2.19%)
    3 / 216 (1.39%)
    3 / 237 (1.27%)
    2 / 231 (0.87%)
         occurrences all number
    5
    3
    3
    2
    Otitis media acute
    Additional description: Otitis media acute
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Otitis media chronic
    Additional description: Otitis media chronic
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Penile infection
    Additional description: Penile infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Papilloma viral infection
    Additional description: Papilloma viral infection
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Parainfluenzae virus infection
    Additional description: Parainfluenzae virus infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Paronychia
    Additional description: Paronychia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    3 / 231 (1.30%)
         occurrences all number
    1
    1
    0
    3
    Parotitis
    Additional description: Parotitis
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Peritonsillar abscess
    Additional description: Peritonsillar abscess
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Pharyngitis
    Additional description: Pharyngitis
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    4 / 231 (1.73%)
         occurrences all number
    1
    2
    1
    4
    Pharyngitis bacterial
    Additional description: Pharyngitis bacterial
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pharyngotonsillitis
    Additional description: Pharyngotonsillitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pneumonia mycoplasmal
    Additional description: Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pneumonia streptococcal
    Additional description: Pneumonia streptococcal
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Post-acute COVID-19 syndrome
    Additional description: Post-acute COVID-19 syndrome
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Postoperative wound infection
    Additional description: Postoperative wound infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    1
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    17 / 228 (7.46%)
    17 / 216 (7.87%)
    10 / 237 (4.22%)
    23 / 231 (9.96%)
         occurrences all number
    19
    21
    14
    30
    Pulpitis dental
    Additional description: Pulpitis dental
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Pyelonephritis
    Additional description: Pyelonephritis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pyuria
    Additional description: Pyuria
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Respiratory syncytial virus infection
    Additional description: Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Respiratory tract infection
    Additional description: Respiratory tract infection
         subjects affected / exposed
    16 / 228 (7.02%)
    13 / 216 (6.02%)
    17 / 237 (7.17%)
    12 / 231 (5.19%)
         occurrences all number
    16
    15
    21
    14
    Respiratory tract infection viral
    Additional description: Respiratory tract infection viral
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Rhinitis
    Additional description: Rhinitis
         subjects affected / exposed
    8 / 228 (3.51%)
    5 / 216 (2.31%)
    5 / 237 (2.11%)
    8 / 231 (3.46%)
         occurrences all number
    9
    5
    5
    9
    Sialoadenitis
    Additional description: Sialoadenitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Root canal infection
    Additional description: Root canal infection
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Scarlet fever
    Additional description: Scarlet fever
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Scrotal infection
    Additional description: Scrotal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Sebaceous gland infection
    Additional description: Sebaceous gland infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    25 / 228 (10.96%)
    8 / 216 (3.70%)
    12 / 237 (5.06%)
    18 / 231 (7.79%)
         occurrences all number
    38
    8
    14
    21
    Skin infection
    Additional description: Skin infection
         subjects affected / exposed
    5 / 228 (2.19%)
    5 / 216 (2.31%)
    3 / 237 (1.27%)
    5 / 231 (2.16%)
         occurrences all number
    5
    5
    3
    7
    Soft tissue infection
    Additional description: Soft tissue infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Staphylococcal infection
    Additional description: Staphylococcal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Subcutaneous abscess
    Additional description: Subcutaneous abscess
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Sycosis barbae
    Additional description: Sycosis barbae
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tinea pedis
    Additional description: Tinea pedis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    1
    0
    0
    3
    Tinea infection
    Additional description: Tinea infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    0
    0
    0
    2
    Tonsillitis
    Additional description: Tonsillitis
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 216 (0.93%)
    1 / 237 (0.42%)
    6 / 231 (2.60%)
         occurrences all number
    1
    2
    1
    6
    Tooth abscess
    Additional description: Tooth abscess
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    0
    0
    1
    Tooth infection
    Additional description: Tooth infection
         subjects affected / exposed
    4 / 228 (1.75%)
    1 / 216 (0.46%)
    9 / 237 (3.80%)
    4 / 231 (1.73%)
         occurrences all number
    4
    1
    9
    4
    Tracheitis
    Additional description: Tracheitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urethritis
    Additional description: Urethritis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    1
    0
    1
    Vaginal infection
    Additional description: Vaginal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    4 / 237 (1.69%)
    6 / 231 (2.60%)
         occurrences all number
    0
    1
    5
    6
    Urosepsis
    Additional description: Urosepsis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection viral
    Additional description: Urinary tract infection viral
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Urinary tract infection bacterial
    Additional description: Urinary tract infection bacterial
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    1
    2
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    24 / 228 (10.53%)
    16 / 216 (7.41%)
    14 / 237 (5.91%)
    29 / 231 (12.55%)
         occurrences all number
    27
    20
    22
    47
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    36 / 228 (15.79%)
    39 / 216 (18.06%)
    24 / 237 (10.13%)
    37 / 231 (16.02%)
         occurrences all number
    52
    56
    33
    55
    Viral upper respiratory tract infection
    Additional description: Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    0 / 231 (0.00%)
         occurrences all number
    1
    1
    3
    0
    Viral sinusitis
    Additional description: Viral sinusitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    5 / 228 (2.19%)
    3 / 216 (1.39%)
    5 / 237 (2.11%)
    4 / 231 (1.73%)
         occurrences all number
    7
    3
    5
    5
    Vestibular neuronitis
    Additional description: Vestibular neuronitis
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Varicella zoster virus infection
    Additional description: Varicella zoster virus infection
         subjects affected / exposed
    0 / 228 (0.00%)
    3 / 216 (1.39%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Vulvovaginal candidiasis
    Additional description: Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vulvovaginal mycotic infection
    Additional description: Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Wound infection
    Additional description: Wound infection
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Metabolism and nutrition disorders
    Abnormal weight gain
    Additional description: Abnormal weight gain
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Acidosis
    Additional description: Acidosis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Alcohol intolerance
    Additional description: Alcohol intolerance
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    11 / 228 (4.82%)
    14 / 216 (6.48%)
    12 / 237 (5.06%)
    16 / 231 (6.93%)
         occurrences all number
    14
    18
    12
    19
    Diabetes mellitus
    Additional description: Diabetes mellitus
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    1
    1
    0
    1
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    2 / 231 (0.87%)
         occurrences all number
    1
    1
    0
    2
    Dyslipidaemia
    Additional description: Dyslipidaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Fluid overload
    Additional description: Fluid overload
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Folate deficiency
    Additional description: Folate deficiency
         subjects affected / exposed
    3 / 228 (1.32%)
    1 / 216 (0.46%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    3
    1
    1
    1
    Gout
    Additional description: Gout
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 216 (0.93%)
    2 / 237 (0.84%)
    3 / 231 (1.30%)
         occurrences all number
    0
    2
    2
    4
    Hyperphosphataemia
    Additional description: Hyperphosphataemia
         subjects affected / exposed
    4 / 228 (1.75%)
    0 / 216 (0.00%)
    10 / 237 (4.22%)
    6 / 231 (2.60%)
         occurrences all number
    4
    0
    14
    6
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    8 / 228 (3.51%)
    6 / 216 (2.78%)
    18 / 237 (7.59%)
    10 / 231 (4.33%)
         occurrences all number
    11
    6
    26
    11
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    6 / 228 (2.63%)
    3 / 216 (1.39%)
    1 / 237 (0.42%)
    1 / 231 (0.43%)
         occurrences all number
    6
    3
    1
    1
    Hypercholesterolaemia
    Additional description: Hypercholesterolaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    0 / 231 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypercalcaemia
    Additional description: Hypercalcaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    4 / 231 (1.73%)
         occurrences all number
    0
    0
    0
    5
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    2 / 237 (0.84%)
    5 / 231 (2.16%)
         occurrences all number
    0
    0
    2
    6
    Hypomagnesaemia
    Additional description: Hypomagnesaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    5 / 231 (2.16%)
         occurrences all number
    1
    0
    0
    6
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    5 / 228 (2.19%)
    4 / 216 (1.85%)
    4 / 237 (1.69%)
    14 / 231 (6.06%)
         occurrences all number
    7
    4
    5
    20
    Hypoferritinaemia
    Additional description: Hypoferritinaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Hypocalcaemia
    Additional description: Hypocalcaemia
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    6 / 231 (2.60%)
         occurrences all number
    2
    1
    3
    8
    Hyperuricaemia
    Additional description: Hyperuricaemia
         subjects affected / exposed
    7 / 228 (3.07%)
    2 / 216 (0.93%)
    9 / 237 (3.80%)
    9 / 231 (3.90%)
         occurrences all number
    8
    2
    9
    10
    Hypophosphataemia
    Additional description: Hypophosphataemia
         subjects affected / exposed
    5 / 228 (2.19%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    9 / 231 (3.90%)
         occurrences all number
    11
    0
    2
    15
    Increased appetite
    Additional description: Increased appetite
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Iron deficiency
    Additional description: Iron deficiency
         subjects affected / exposed
    4 / 228 (1.75%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    9 / 231 (3.90%)
         occurrences all number
    4
    0
    1
    9
    Iron overload
    Additional description: Iron overload
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Obesity
    Additional description: Obesity
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    0
    0
    0
    1
    Tumour lysis syndrome
    Additional description: Tumour lysis syndrome
         subjects affected / exposed
    17 / 228 (7.46%)
    7 / 216 (3.24%)
    19 / 237 (8.02%)
    13 / 231 (5.63%)
         occurrences all number
    20
    7
    22
    13
    Type 2 diabetes mellitus
    Additional description: Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 228 (0.00%)
    0 / 216 (0.00%)
    1 / 237 (0.42%)
    0 / 231 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vitamin D deficiency
    Additional description: Vitamin D deficiency
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 216 (0.46%)
    2 / 237 (0.84%)
    5 / 231 (2.16%)
         occurrences all number
    2
    1
    2
    5
    Vitamin B12 deficiency
    Additional description: Vitamin B12 deficiency
         subjects affected / exposed
    3 / 228 (1.32%)
    1 / 216 (0.46%)
    0 / 237 (0.00%)
    1 / 231 (0.43%)
         occurrences all number
    3
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Feb 2017
    Israel and Ireland were included as participating countries. Availability of SmPC as reference document for Venetoclax due to approval by EMA in December 2016, additionally, new data for administration of venetoclax became available. The study duration was adapted after start of recruitment. The recommended porphylaxis in case of HBV DNA detection was adapted following the newest guidelines. Due to new safety information for obinutuzumab regarding infections, dose and schedule modifications in the RVe/GVe or GIVe arm were adapted. New safety information for ibrutinib regarding interstitial lung disease became available and was included in the protocol. Ultrasound testing at baseline was deleted from the protocol, as CT/MRI is mandatory at baseline.
    13 Jul 2017
    The non-use of Rituximab bio-similars was specified in the protocol. MRD measurements are no longer performed by four-color, but by multi-colour-flow-cytometry. Dose and schedule modifications for venetoclax in case of febrile neutropenia and thrombocytopenia during ramp up were clarified. An additional appendix for TLS-risk-mangement was added.
    05 Sep 2017
    Amendment following updated Venetoclax IMPD. Changes in PIC due to EU general data protection regulation werde made, not all countries were affected.
    12 Dec 2018
    Cancer Trials Ireland and the Israeli CLL Study Group were added as participating study group in the title. Additional participating protocol committee members were added as well as the coordinating physician. Accepted delay of study visits was extended to +/- 14 days. Prior treatment with rituximab was added as an exclusion criterion. Hospitalization as prophylaxis of TLS in venetoclax as well as the 2h-post-venetoclax laboratory assessment were not necessarily recommended anymore. Non TLS-related hyperphosphatemia is not a reason for interruption of venetoclax treatment anymore. Due to possibly increased rate of aspergilloses in iburtinib-containing treatment, recommendations concercning infection prophylaxis were added to the protocol. Adjustments according to SmPC of venetoclax were made.
    19 Feb 2020
    Changes on frequency of HBV PCR testing were made, pelvis and was included in radiological assessment at baseline, additional sampling (ctDNA) from pB was added in the protocol. Adjustments in safety reporting were made.
    26 Apr 2021
    Adjustments and specifications of the statistical chapter were made, MRD analysis by MGS was added as an exploratory endpoint. A chapter regarding Benefit-Risk-Assessment during the Covid-19 pandemic was added to the protocol.
    26 Apr 2021
    non-substantial amendment. New SmPCs available
    12 Dec 2022
    FU intervals were updated and extended to 13 months.

    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/37172204
    http://www.ncbi.nlm.nih.gov/pubmed/32601378
    http://www.ncbi.nlm.nih.gov/pubmed/37163621
    http://www.ncbi.nlm.nih.gov/pubmed/38821083
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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