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    Clinical Trial Results:
    A Randomized Study Comparing Maintenance Therapy with Subcutaneous Rituximab Continued Until Progression with Observation Only in Patients with Relapsed or Refractory, Indolent Non-Hodgkin's Lymphoma who Completed and Responded to Rituximab-based Immunochemotherapy Induction and Initial 2-year Rituximab Maintenance Therapy Administered Subcutaneously

    Summary
    EudraCT number
    		 2010-023407-95
    Trial protocol
    		 GB   DE   SE   AT   SK   LT   HU   FR   ES   SI   IT   GR  
    Global end of trial date
    02 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jun 2019
    First version publication date
    16 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MO25455
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01461928
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, globa.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, globa.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the efficacy of a subcutaneous (SC) formulation of rituximab in terms of progression-free survival after randomization (PFSrand) to either prolonged rituximab maintenance until progression (Maintenance II) or observation in subjects with relapsed or refractory, indolent non-Hodgkin’s lymphoma who responded to Induction and initial 2 years maintenance therapy (Maintenance I) at the end of study (EOS).
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 2011
    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
    Albania: 18
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Brazil: 50
    Country: Number of subjects enrolled
    Bulgaria: 12
    Country: Number of subjects enrolled
    Colombia: 6
    Country: Number of subjects enrolled
    Ecuador: 6
    Country: Number of subjects enrolled
    Egypt: 11
    Country: Number of subjects enrolled
    France: 128
    Country: Number of subjects enrolled
    Germany: 33
    Country: Number of subjects enrolled
    Greece: 24
    Country: Number of subjects enrolled
    Hungary: 28
    Country: Number of subjects enrolled
    Italy: 115
    Country: Number of subjects enrolled
    Lithuania: 2
    Country: Number of subjects enrolled
    Norway: 18
    Country: Number of subjects enrolled
    Romania: 13
    Country: Number of subjects enrolled
    Russian Federation: 39
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Slovenia: 2
    Country: Number of subjects enrolled
    Spain: 61
    Country: Number of subjects enrolled
    Sweden: 10
    Country: Number of subjects enrolled
    Turkey: 9
    Country: Number of subjects enrolled
    United Kingdom: 90
    Country: Number of subjects enrolled
    Switzerland: 1
    Worldwide total number of subjects
    692
    EEA total number of subjects
    546
    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)
    322
    From 65 to 84 years
    355
    85 years and over
    15

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were identified for potential recruitment using pre-screening enrolment logs.

    Pre-assignment
    Screening details
    		 Subjects were treated with an induction regimen (6 months) and received SC rituximab at a dose of 375 mg/m2 with chemotherapy followed by 2 years of Maintenance I SC rituximab of 1400 mg alone. Responding subjects at the end of Maintenance I were randomised to either Maintenance II rituximab treatment or observation only.

    Pre-assignment period milestones
    Number of subjects started
    		 692
    Intermediate milestone: Number of subjects
    Maintenance I: 494
    Number of subjects completed
    		 276

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse Event (AE): 146
    Reason: Number of subjects
    		 Disease progression: 136
    Reason: Number of subjects
    		 Lost to follow-up: 7
    Reason: Number of subjects
    		 Physician decision: 18
    Reason: Number of subjects
    		 Consent withdrawn by subject: 50
    Reason: Number of subjects
    		 Eligibility criteria deviation: 10
    Reason: Number of subjects
    		 Completed Induction, no Maint I received: 11
    Reason: Number of subjects
    		 Not responding to treatment: 11
    Reason: Number of subjects
    		 Termination of study in Switzerland: 1
    Reason: Number of subjects
    		 Treated before eligibility was confirmed: 1
    Reason: Number of subjects
    		 Sponsor decision: 1
    Reason: Number of subjects
    		 Protocol deviation: 2
    Reason: Number of subjects
    		 Prednisolone given prior to enrolment: 1
    Reason: Number of subjects
    		 Cycle 7 rituximab not given in error: 1
    Reason: Number of subjects
    		 Promotor request: 1
    Reason: Number of subjects
    		 Exceeded time limit for next cycle: 1
    Reason: Number of subjects
    		 Medical advisor request: 1
    Reason: Number of subjects
    		 Did not meet randomization criteria: 2
    Reason: Number of subjects
    		 Did not perform scheduled assessment: 2
    Reason: Number of subjects
    		 Delay in rituximab administration: 1
    Reason: Number of subjects
    		 Death: 6
    Reason: Number of subjects
    		 Not compliant: 1
    Reason: Number of subjects
    		 Did not meet criteria: 5
    Period 1
    Period 1 title
    Maintenance II (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Subjects received SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    rituximab
    Investigational medicinal product code
    Other name
    Mabthera
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single dose of subcutaneous injection at a dose of 1400 mg without chemotherapy administered every 8 weeks

    Arm title
    		 Arm B (Observation only)
    Arm description
    		 Subjects did not receive further rituximab treatment until the end of study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		Arm A Arm B (Observation only)
    Started
    138
    138
    Completed
    115
    111
    Not completed
    23
    27
         Moved to another town
    1
    -
         Consent withdrawn by subject
    9
    8
         Physician decision
    -
    4
         Disease progression
    -
    3
         Changed physician in another hospital
    -
    1
         Withdrew informed consent
    -
    1
         Death
    10
    8
         Squamous lung carcinoma
    -
    1
         Adverse event
    2
    -
         Refused to be transferred to other site
    -
    1
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The main reporting group included randomised subjects who were a subset of the overall worldwide enrollment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Subjects received SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.

    Reporting group title
    Arm B (Observation only)
    Reporting group description
    		 Subjects did not receive further rituximab treatment until the end of study.

    Reporting group values
    		 Arm A Arm B (Observation only) Total
    Number of subjects
    		 138 138 276
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 76 68 144
        From 65-84 years
    		 60 69 129
        Elderly 85 years and over
    		 2 1 3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.2 ( 10.33 ) 63.7 ( 10.93 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 64 70 134
        Male
    		 74 68 142

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Subjects received SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.

    Reporting group title
    Arm B (Observation only)
    Reporting group description
    		 Subjects did not receive further rituximab treatment until the end of study.

    Subject analysis set title
    Intent-to-Treat (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population included all subjects who had completed a Baseline visit and at least one on-treatment assessment. The ITT population was used for the analysis of secondary efficacy parameters and Baseline variables. All subjects who were enrolled into the given study period and had received at least one dose of study treatment at any time were included in the ITT population for each period of the study; Induction, Maintenance I and Maintenance II.

    Subject analysis set title
    Maintenance I Subjects
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Maintenance I subject analysis group consisted of a subgroup of responding subjects who completed Induction and successfully enrolled into Maintenance I.

    Subject analysis set title
    Randomised Intent-to-Treat
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The primary efficacy analysis population was the ITT population (ITTrand), which included only randomised subjects (Maintenance II only) and was used for the analysis of the primary efficacy endpoint of PFS and the secondary analysis endpoint overall survival (OS).

    Subject analysis set title
    Safety Population (All study periods)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAF population included all subjects who had received at least one dose of rituximab during the study and were assigned to treatment groups as treated. All safety analyses were based on the SAF. All subjects were included in the SAF population for each period of the study; Induction, Maintenance I and Maintenance II.

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A PP analysis (PPrand) was performed with Maintenance II subjects from the ITTrand population who had no major protocol violations that may have impacted the primary analysis.

    Primary: Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia

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    End point title
    		 Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
    End point description
    Progression free survival from randomization (PFSrand) is defined as the time from date of randomization to the date of first documented disease progression or death, whichever occurs first. The primary efficacy analysis population was the ITT population (ITTrand), which included only randomised subjects (Maintenance II only) and was used for the analysis of the primary efficacy endpoint of PFS and the secondary analysis endpoint overall survival (OS). The Observation arm did not include one subject with AE outcome of death reported retrospectively 2 months after discontinuation from study (censored as having no event on Day 456 post-randomisation). The end point was not reached. 9999=not estimable
    End point type
    Primary
    End point timeframe
    From randomization (Maintenance II) up to disease progression or death, whichever occurs first
    End point values
    		 Arm A Arm B (Observation only)
    Number of subjects analysed
    138
    138 [1]
    Units: Month
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (39.75 to 9999)
    Notes
    [1] - 2 subjects died due to an SAE and were not considered in the analysis as no death page was completed
    Statistical analysis title
    		 Stratified log-rank test
    Statistical analysis description
    The stratified log rank test p-value was derived using the following randomization stratification strata : Follicular Lymphoma International Prognostic Index (FLIPI) risk category (low, intermediate, high) and indolent NHL subtype (follicular lymphoma, non-follicular lymphoma).
    Comparison groups
    Arm B (Observation only) v Arm A
    Number of subjects included in analysis
    276
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.41 [3]
    Method
    		 Stratified Long-rank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.53
    Notes
    [2] - Power at time of final analysis was less than 40%. Final analysis was not able to address it's primary objective.
    [3] - Power at time of final analysis was less than 40%. Final analysis was not able to address it's primary objective.

    Secondary: Number of Subjects with Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs)

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    End point title
    		 Number of Subjects with Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs)
    End point description
    An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. The safety population included all subjects who received at least one dose of study drug and had a safety assessment performed post randomisation. Not all AEs were followed up for the randomised Observation arm. Only Serious AEs and AE grade 3-5 (obtained retrospectively) were collected for this arm. Therefore arms are not comparable overall.
    End point type
    Secondary
    End point timeframe
    From day of first rituximab induction dose up to day of disease progression, or discontinuation of treatment for any reason (up to approximately 87 months)
    End point values
    		 Safety Population (All study periods)
    Number of subjects analysed
    692
    Units: Subjects
    number (not applicable)
        Number of Subjects with Adverse Events
    643
        Number of Subjects with Serious Adverse Events
    339
        Number of Subjects with IRRs/ARRs
    330
    No statistical analyses for this end point

    Secondary: Event-free Survival (Time to Treatment Failure) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia

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    End point title
    		 Event-free Survival (Time to Treatment Failure) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia [4]
    End point description
    The analysis population was the randomised ITT population (ITTrand), which included only randomised subjects (Maintenance II only) as well as the ITT population, that included all subjects who had completed a Baseline visit and at least one on-treatment assessment. The ITT population included all subjects who had completed a Baseline visit and at least one on-treatment assessment. All subjects who were enrolled into the given study period and had received at least one dose of study treatment at any time were included in the ITT population for each period of the study; Induction, Maintenance I and Maintenance II. 9999=not estimable
    End point type
    Secondary
    End point timeframe
    From day of first rituximab induction dose up to day of any treatment failure, including disease progression, or discontinuation of treatment for any reason (up to approximately 87 months)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was provided only for those arms which were planned to be reported.
    End point values
    		 Arm A Intent-to-Treat (ITT)
    Number of subjects analysed
    138 [5]
    692 [6]
    Units: Months
        median (confidence interval 95%)
    65.38 (60.98 to 9999)
    24.99 (20.73 to 27.99)
    Notes
    [5] - Treatment discontinuation was considered as an event, not applicable to observation arm.
    [6] - Biased as treatment discontinuation was considered as an event, not applicable to observation arm.
    No statistical analyses for this end point

    Secondary: Time to Next Lymphoma Treatment (TNLT)

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    End point title
    		 Time to Next Lymphoma Treatment (TNLT)
    End point description
    Time to next lymphoma treatment (TNLT) is defined as the time from date of first rituximab induction dose to the date date of first documented intake of any new antilymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc.). The analysis population was the randomised ITT population (ITTrand), which included only randomised subjects (Maintenance II only) as well as the ITT population, that included all subjects who had completed a Baseline visit and at least one on-treatment assessment. The ITT population included all subjects who had completed a Baseline visit and at least one on-treatment assessment. All subjects who were enrolled into the given study period and had received at least one dose of study treatment at any time were included in the ITT population for each period of the study; Induction, Maintenance I and Maintenance II. The end point was not reached. 9999=not estimable
    End point type
    Secondary
    End point timeframe
    From day of first rituximab induction dose up to any new lymphoma treatment (up to approximately 87 months)
    End point values
    		 Arm A Arm B (Observation only) Intent-to-Treat (ITT)
    Number of subjects analysed
    138
    138 [7]
    692
    Units: Months
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Notes
    [7] - Biased as subjects stopped treatment and were likely to receive NLT earlier.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival from first induction treatment (OSRegist) is defined as the time from date of first rituximab induction dose to the date of death, irrespective of cause The ITT population included all subjects who had completed a Baseline visit and at least one on-treatment assessment. All subjects who were enrolled into the given study period and had received at least one dose of study treatment at any time were included in the ITT population for each period of the study; Induction, Maintenance I and Maintenance II. One subject died in Induction before randomization and one subject died in Maintenance II Observation arm due to an SAE and was not considered in the analysis as no death page was completed. The Observation arm did not include one subject with AE outcome of death reported retrospectively 2 months after discontinuation from study (censored as having no event on Day 456 post-randomisation). The end point was not reached. 9999= not estimable
    End point type
    Secondary
    End point timeframe
    From day of first rituximab induction dose up to death (up to approximately 87 months)
    End point values
    		 Intent-to-Treat (ITT)
    Number of subjects analysed
    692 [8]
    Units: Months
        median (confidence interval 95%)
    9999 (9999 to 9999)
    Notes
    [8] - Randomised arms pooled as it includes information prior to randomisation. Interpret with caution.
    No statistical analyses for this end point

    Secondary: Maintenance II: Overall Survival

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    End point title
    		 Maintenance II: Overall Survival
    End point description
    Overall survival from randomization (OSrand) is defined as the time from date of randomization to the date of death, irrespective of cause. The analysis population was the randomised ITT population (ITTrand), which included only randomised subjects (Maintenance II only) and was used for the analysis of the primary efficacy endpoint of PFS and the secondary analysis endpoint overall survival (OS). The end point was not reached. 9999=not estimable
    End point type
    Secondary
    End point timeframe
    From randomization (Maintenance II) up to death (up to approximately 24 months)
    End point values
    		 Arm A Arm B (Observation only)
    Number of subjects analysed
    138
    138
    Units: Months
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Partial Response (PR) or Complete Response (CR) Tumor response assessment at end of Induction Using 1999 International Working Group Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia

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    End point title
    		 Percentage of Subjects with Partial Response (PR) or Complete Response (CR) Tumor response assessment at end of Induction Using 1999 International Working Group Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
    End point description
    The ITT population included all subjects who had completed a Baseline visit and at least one on-treatment assessment.
    End point type
    Secondary
    End point timeframe
    From day of first rituximab induction dose up to end of induction period (up to approximately 8 months)
    End point values
    		 Intent-to-Treat (ITT)
    Number of subjects analysed
    692
    Units: Percentage
        number (confidence interval 95%)
    84.7 (81.8 to 87.3)
    No statistical analyses for this end point

    Secondary: Maintenance I: Percentage of Subjects with Conversion of PR to CR Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia

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    End point title
    		 Maintenance I: Percentage of Subjects with Conversion of PR to CR Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
    End point description
    The Maintenance I subject analysis group consisted of a subgroup of responding subjects who completed Induction and successfully enrolled into Maintenance I. Subjects who had partial response (PR) at the end of Induction were included in this analysis.
    End point type
    Secondary
    End point timeframe
    From day of first rituximab induction dose up to end of Maintenance I period (up to approximately 32 months)
    End point values
    		 Maintenance I Subjects
    Number of subjects analysed
    357
    Units: Number
        number (confidence interval 95%)
    21.6 (17.4 to 26.2)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia

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    End point title
    		 Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
    End point description
    Progression free survival from first induction treatment (PFSregist) is defined as the time from date of first rituximab induction dose to the date of first documented disease progression or death by any cause, whichever occurs first. The ITT population included all subjects who had completed a Baseline visit and at least one on-treatment assessment. All subjects who were enrolled into the given study period and had received at least one dose of study treatment at any time were included in the ITT population for each period of the study; Induction, Maintenance I and Maintenance II.
    End point type
    Secondary
    End point timeframe
    From day of first rituximab induction dose up to disease progression or death, whichever occurs first (up to approximately 87 months)
    End point values
    		 Intent-to-Treat (ITT)
    Number of subjects analysed
    692
    Units: Months
        median (confidence interval 95%)
    59.33 (50.33 to 71.36)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline up to 87 months
    Adverse event reporting additional description
    The SAF population included all subjects who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomised Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Subjects received SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.

    Reporting group title
    All Subjects
    Reporting group description
    		 Subjects were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Subjects who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomised to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).

    Reporting group title
    Arm B (Observation only)
    Reporting group description
    		 Subjects did not receive further rituximab treatment until the end of study.

    Serious adverse events
    		 Arm A All Subjects Arm B (Observation only)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    59 / 138 (42.75%)
    339 / 692 (48.99%)
    58 / 138 (42.03%)
         number of deaths (all causes)
    10
    161
    8
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestine adenocarcinoma
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Refractory Anaemia With An Excess Of Blasts
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Nodal Marginal Zone B-Cell Lymphoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Naevoid melanoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myeloid leukaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 138 (0.72%)
    9 / 692 (1.30%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Malignant melanoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lentigo maligna
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large cell lung cancer
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular Carcinoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Carcinoid tumour of the stomach
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaplastic astrocytoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Anal squamous cell carcinoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    Surgical and medical procedures
    Venous thrombosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic vasculitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Flushing
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia repair
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 138 (0.72%)
    11 / 692 (1.59%)
    3 / 138 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    5 / 16
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injection site reaction
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injection site pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injection site induration
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injection site haematoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injection site erythema
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infusion site erythema
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Feeling hot
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Face oedema
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    Chills
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Immunosupression
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menometrorrhagia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Throat irritation
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Haemoptysis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 138 (0.72%)
    6 / 692 (0.87%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    2 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth avulsion
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    3 / 138 (2.17%)
    7 / 692 (1.01%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    7 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complications of bone marrow transplant
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Myocardial ischaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardic arrest
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 138 (1.45%)
    7 / 692 (1.01%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve calcification
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemiplegic migraine
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    Cerebral atrophy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 138 (0.72%)
    22 / 692 (3.18%)
    6 / 138 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    22 / 29
    10 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphopenia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperviscosity syndrome
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    4 / 138 (2.90%)
    36 / 692 (5.20%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    3 / 5
    28 / 42
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone marrow failure
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    8 / 692 (1.16%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 10
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inflammatory bowel disease
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal toxicity
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticular perporation
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 138 (0.72%)
    10 / 692 (1.45%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 12
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin reaction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash papular
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peau D'orange
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urethral haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 138 (0.00%)
    6 / 692 (0.87%)
    3 / 138 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Endocrine disorders
    Thyrotxic crisis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    14 / 138 (10.14%)
    54 / 692 (7.80%)
    6 / 138 (4.35%)
         occurrences causally related to treatment / all
    6 / 14
    22 / 65
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    1 / 9
    0 / 1
    Sepsis
         subjects affected / exposed
    3 / 138 (2.17%)
    18 / 692 (2.60%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 3
    7 / 18
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    5 / 9
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 138 (2.17%)
    12 / 692 (1.73%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 13
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 138 (0.00%)
    8 / 692 (1.16%)
    3 / 138 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 9
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 138 (0.72%)
    6 / 692 (0.87%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    1 / 3
    0 / 0
    Sepsis syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 138 (0.72%)
    9 / 692 (1.30%)
    2 / 138 (1.45%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 9
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Progressive multifocal leukoencephalopathy
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Pneumocystis Jirovecii pneumonia
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Pneumococcal infection
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perineal cellulitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraspinal abscess
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocarditis septic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Myocarditis infectious
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    2 / 138 (1.45%)
    7 / 692 (1.01%)
    4 / 138 (2.90%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 7
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 138 (0.72%)
    10 / 692 (1.45%)
    5 / 138 (3.62%)
         occurrences causally related to treatment / all
    1 / 1
    5 / 11
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal sepsis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis viral
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Hepatitis C
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic candidiasis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    4 / 138 (2.90%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 5
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A All Subjects Arm B (Observation only)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    133 / 138 (96.38%)
    643 / 692 (92.92%)
    133 / 138 (96.38%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    5 / 138 (3.62%)
    17 / 692 (2.46%)
    5 / 138 (3.62%)
         occurrences all number
    5
    19
    5
    Bowen's disease
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences all number
    0
    3
    2
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 138 (1.45%)
    7 / 692 (1.01%)
    1 / 138 (0.72%)
         occurrences all number
    2
    8
    1
    Acrochordon
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Breast cancer
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Lipoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Lobular breast carcinoma in situ
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Melanocytic naevus
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Paget's disease of nipple
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Prostate cancer
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Skin papilloma
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    3
    3
    0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 138 (0.72%)
    6 / 692 (0.87%)
    2 / 138 (1.45%)
         occurrences all number
    1
    6
    2
    Uterine leiomyoma
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Sweat gland tumour
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Leiomyoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Large intestine benign neoplasm
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Large cell lung cancer
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Keratoacanthoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Angiopathy
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Aortic arteriosclerosis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Aortic aneurysm
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Arteriosclerosis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Surgical and medical procedures
    Hypotension
         subjects affected / exposed
    2 / 138 (1.45%)
    19 / 692 (2.75%)
    3 / 138 (2.17%)
         occurrences all number
    2
    21
    3
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    2
    Aortic stenosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Ischaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Poor venous access
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Tooth extraction
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    0
    Astringent therapy
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    1
    Central venous catheter removal
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    1
    Cholecystectomy
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 692 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    Foot operation
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Hip arthroplasty
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Mass excision
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 692 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    Nephrostomy
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Shoulder arthroplasty
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Skin neoplasm excision
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 692 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    Venous thrombosis limb
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Venous thrombosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Varicose vein
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    1
    4
    1
    Varicose ulceration
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Thrombophlebitis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Subclavian vein thrombosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Spider vein
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Phlebitis superficial
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Phlebitis
         subjects affected / exposed
    2 / 138 (1.45%)
    6 / 692 (0.87%)
    3 / 138 (2.17%)
         occurrences all number
    2
    7
    3
    Peripheral venous disease
         subjects affected / exposed
    3 / 138 (2.17%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    4
    5
    1
    Peripheral ischaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Peripheral coldness
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Pallor
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Intermittent claudication
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Hypertensive crisis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Hypertension
         subjects affected / exposed
    18 / 138 (13.04%)
    45 / 692 (6.50%)
    5 / 138 (3.62%)
         occurrences all number
    27
    57
    6
    Hyperaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Hot flush
         subjects affected / exposed
    1 / 138 (0.72%)
    8 / 692 (1.16%)
    1 / 138 (0.72%)
         occurrences all number
    1
    16
    1
    Haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Haematoma
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    2
    5
    1
    Flushing
         subjects affected / exposed
    2 / 138 (1.45%)
    8 / 692 (1.16%)
    2 / 138 (1.45%)
         occurrences all number
    2
    8
    2
    Essential hypertension
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Embolism
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    Cataract operation
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    4 / 138 (2.90%)
         occurrences all number
    1
    0
    5
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    32 / 138 (23.19%)
    159 / 692 (22.98%)
    28 / 138 (20.29%)
         occurrences all number
    45
    258
    49
    Fatigue
         subjects affected / exposed
    30 / 138 (21.74%)
    115 / 692 (16.62%)
    19 / 138 (13.77%)
         occurrences all number
    46
    157
    25
    Asthenia
         subjects affected / exposed
    27 / 138 (19.57%)
    113 / 692 (16.33%)
    19 / 138 (13.77%)
         occurrences all number
    43
    167
    28
    Chest pain
         subjects affected / exposed
    11 / 138 (7.97%)
    27 / 692 (3.90%)
    7 / 138 (5.07%)
         occurrences all number
    12
    29
    7
    Infusion site erythema
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences all number
    6
    16
    0
    Chills
         subjects affected / exposed
    8 / 138 (5.80%)
    40 / 692 (5.78%)
    9 / 138 (6.52%)
         occurrences all number
    8
    47
    9
    Influenza like illness
         subjects affected / exposed
    6 / 138 (4.35%)
    20 / 692 (2.89%)
    6 / 138 (4.35%)
         occurrences all number
    24
    45
    9
    Mucosal inflammation
         subjects affected / exposed
    6 / 138 (4.35%)
    25 / 692 (3.61%)
    7 / 138 (5.07%)
         occurrences all number
    6
    27
    8
    Oedema peripheral
         subjects affected / exposed
    6 / 138 (4.35%)
    38 / 692 (5.49%)
    7 / 138 (5.07%)
         occurrences all number
    6
    40
    8
    Chest discomfort
         subjects affected / exposed
    3 / 138 (2.17%)
    10 / 692 (1.45%)
    3 / 138 (2.17%)
         occurrences all number
    3
    10
    3
    General physical health deterioration
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences all number
    3
    5
    0
    Hyperthermia
         subjects affected / exposed
    3 / 138 (2.17%)
    7 / 692 (1.01%)
    1 / 138 (0.72%)
         occurrences all number
    4
    8
    1
    Injection site induration
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    9
    17
    2
    Infusion site inflammation
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Injection site pain
         subjects affected / exposed
    3 / 138 (2.17%)
    24 / 692 (3.47%)
    6 / 138 (4.35%)
         occurrences all number
    3
    34
    7
    Oedema
         subjects affected / exposed
    3 / 138 (2.17%)
    9 / 692 (1.30%)
    2 / 138 (1.45%)
         occurrences all number
    3
    9
    2
    Pain
         subjects affected / exposed
    3 / 138 (2.17%)
    8 / 692 (1.16%)
    2 / 138 (1.45%)
         occurrences all number
    3
    8
    2
    Hypothermia
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    2
    7
    0
    Injection site discomfort
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Injection site mass
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    2 / 138 (1.45%)
         occurrences all number
    0
    3
    3
    Malaise
         subjects affected / exposed
    2 / 138 (1.45%)
    10 / 692 (1.45%)
    1 / 138 (0.72%)
         occurrences all number
    2
    10
    1
    Peripheral swelling
         subjects affected / exposed
    2 / 138 (1.45%)
    7 / 692 (1.01%)
    0 / 138 (0.00%)
         occurrences all number
    2
    8
    0
    Administration site extravasation
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    6
    0
    Administration site inflammation
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Application site erythema
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Application site pain
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Catheter site thrombosis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Cyst
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Discomfort
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Facial pain
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Feeling abnormal
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Feeling cold
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    Feeling hot
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    0
    5
    1
    Feeling of body temperature change
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Granuloma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Inflammation
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    0
    6
    1
    Injection site erythema
         subjects affected / exposed
    10 / 138 (7.25%)
    38 / 692 (5.49%)
    9 / 138 (6.52%)
         occurrences all number
    11
    46
    14
    Infusion site haematoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Injection site inflammation
         subjects affected / exposed
    0 / 138 (0.00%)
    8 / 692 (1.16%)
    3 / 138 (2.17%)
         occurrences all number
    0
    9
    3
    Injection site bruising
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    1
    5
    1
    Infusion site pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Infusion site rash
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    3
    1
    Injection site discolouration
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    3
    1
    Injection site haematoma
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences all number
    2
    5
    0
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Injection site irritation
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Injection site pruritus
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Performance status decreased
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Injection site reaction
         subjects affected / exposed
    1 / 138 (0.72%)
    10 / 692 (1.45%)
    1 / 138 (0.72%)
         occurrences all number
    2
    13
    1
    Injection site swelling
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    Injection site thrombosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Injection site warmth
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Localised oedema
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Polyp
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Puncture site erythema
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Puncture site pain
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    3
    1
    Unevaluable event
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Vessel puncture site haematoma
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Xerosis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Swelling
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Injection site rash
         subjects affected / exposed
    0 / 138 (0.00%)
    8 / 692 (1.16%)
    1 / 138 (0.72%)
         occurrences all number
    0
    9
    1
    Infusion site extravasation
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    0
    3
    0
    Axillary pain
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Administration site pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Face oedema
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Implant site haematoma
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhagic cyst
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site oedema
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site plaque
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Thirst
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    9 / 138 (6.52%)
    26 / 692 (3.76%)
    9 / 138 (6.52%)
         occurrences all number
    9
    26
    9
    Hypersensitivity
         subjects affected / exposed
    3 / 138 (2.17%)
    7 / 692 (1.01%)
    0 / 138 (0.00%)
         occurrences all number
    3
    7
    0
    Immune system disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Iodine allergy
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    2 / 138 (1.45%)
         occurrences all number
    1
    4
    2
    Sarcoidosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Immunodeficiency
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences all number
    0
    7
    0
    Cytokine release syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    4 / 138 (2.90%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    4
    0
    0
    Amenorrhoea
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Cystocele
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Menstrual disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Ovarian cyst
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    1
    Pelvic discomfort
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Pelvic pain
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    2
    0
    1
    Premature menopause
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    0
    Pruritus genital
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Testicular oedema
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 692 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    Testicular pain
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Vaginal discharge
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    1
    Vulvovaginal erythema
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 692 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    Prostatic discomfort
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 692 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    47 / 138 (34.06%)
    135 / 692 (19.51%)
    24 / 138 (17.39%)
         occurrences all number
    72
    185
    37
    Oropharyngeal pain
         subjects affected / exposed
    15 / 138 (10.87%)
    39 / 692 (5.64%)
    5 / 138 (3.62%)
         occurrences all number
    15
    40
    5
    Dysphonia
         subjects affected / exposed
    6 / 138 (4.35%)
    14 / 692 (2.02%)
    3 / 138 (2.17%)
         occurrences all number
    7
    18
    4
    Dyspnoea
         subjects affected / exposed
    6 / 138 (4.35%)
    55 / 692 (7.95%)
    11 / 138 (7.97%)
         occurrences all number
    7
    62
    11
    Rhinorrhoea
         subjects affected / exposed
    6 / 138 (4.35%)
    14 / 692 (2.02%)
    2 / 138 (1.45%)
         occurrences all number
    6
    14
    2
    Productive cough
         subjects affected / exposed
    5 / 138 (3.62%)
    25 / 692 (3.61%)
    8 / 138 (5.80%)
         occurrences all number
    5
    28
    8
    Epistaxis
         subjects affected / exposed
    3 / 138 (2.17%)
    12 / 692 (1.73%)
    3 / 138 (2.17%)
         occurrences all number
    3
    15
    3
    Rhinitis allergic
         subjects affected / exposed
    3 / 138 (2.17%)
    11 / 692 (1.59%)
    2 / 138 (1.45%)
         occurrences all number
    3
    11
    2
    Asthma
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    2
    6
    3
    Nasal congestion
         subjects affected / exposed
    2 / 138 (1.45%)
    8 / 692 (1.16%)
    2 / 138 (1.45%)
         occurrences all number
    2
    8
    2
    Pharyngeal parasthesia
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    Pleural effusion
         subjects affected / exposed
    2 / 138 (1.45%)
    6 / 692 (0.87%)
    2 / 138 (1.45%)
         occurrences all number
    2
    6
    2
    Sleep apnoea syndrome
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    Throat irritation
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    2
    5
    2
    Atelectasis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Bronchial disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Bronchial obstruction
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Bronchiectasis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Bronchitis chronic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Bronchospasm
         subjects affected / exposed
    1 / 138 (0.72%)
    7 / 692 (1.01%)
    2 / 138 (1.45%)
         occurrences all number
    1
    7
    2
    Catarrh
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    0
    3
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 138 (0.00%)
    6 / 692 (0.87%)
    1 / 138 (0.72%)
         occurrences all number
    0
    7
    1
    Haemoptysis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Increased upper airway secretion
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Laryngeal pain
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Larynx irritation
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Lung disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    2 / 138 (1.45%)
         occurrences all number
    1
    4
    2
    Nasal pruritus
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    2
    Orthopnoea
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Painful respiration
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Pharyngeal inflammation
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Pleuritic pain
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    3
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    1
    5
    1
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Wheezing
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    2 / 138 (1.45%)
         occurrences all number
    0
    4
    2
    Upper airway obstruction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Tracheomalacia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Throat tightness
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Sneezing
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Sinus polyp
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Sinus congestion
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Rhonchi
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Rhinitis atrophic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Rales
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pleurisy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Oropharyngeal discomfort
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Obliterative bronchiolitis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Noninfective bronchitis
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences all number
    0
    4
    0
    Nasal polyps
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal obstruction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Laryngospasm
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Interstitial lung disease
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hiccups
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Emphysema
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    Dry throat
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    5 / 138 (3.62%)
    9 / 692 (1.30%)
    2 / 138 (1.45%)
         occurrences all number
    5
    10
    2
    Bronchomalacia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Asthmatic crisis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    8 / 138 (5.80%)
    20 / 692 (2.89%)
    2 / 138 (1.45%)
         occurrences all number
    8
    20
    2
    Insomnia
         subjects affected / exposed
    7 / 138 (5.07%)
    31 / 692 (4.48%)
    5 / 138 (3.62%)
         occurrences all number
    8
    33
    5
    Sleep disorder
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    2
    5
    1
    Stress
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Anxiety
         subjects affected / exposed
    1 / 138 (0.72%)
    22 / 692 (3.18%)
    9 / 138 (6.52%)
         occurrences all number
    1
    23
    9
    Anxiety disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Confusional state
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    1
    5
    1
    Restlessness
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Panic attack
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Mood altered
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Loss of libido
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Feeling of despair
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Depressed mood
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Delirium
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Agitation
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    4 / 138 (2.90%)
    14 / 692 (2.02%)
    1 / 138 (0.72%)
         occurrences all number
    4
    16
    1
    Alanine aminitransferase increased
         subjects affected / exposed
    3 / 138 (2.17%)
    11 / 692 (1.59%)
    3 / 138 (2.17%)
         occurrences all number
    3
    20
    7
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 138 (2.17%)
    11 / 692 (1.59%)
    3 / 138 (2.17%)
         occurrences all number
    3
    13
    4
    CD4 lymphocytes decreased
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    3 / 138 (2.17%)
         occurrences all number
    0
    3
    3
    Blood bilirubin increased
         subjects affected / exposed
    2 / 138 (1.45%)
    6 / 692 (0.87%)
    2 / 138 (1.45%)
         occurrences all number
    2
    6
    2
    Blood pressure abnormal
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Biopsy prostate
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 138 (0.72%)
    8 / 692 (1.16%)
    1 / 138 (0.72%)
         occurrences all number
    1
    9
    1
    Blood creatine increased
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    3
    4
    1
    Cardiac murmur
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Transaminases increased
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    2
    6
    1
    White blood cell count increased
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    11 / 138 (7.97%)
    46 / 692 (6.65%)
    13 / 138 (9.42%)
         occurrences all number
    19
    72
    21
    Weight increased
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    0
    6
    1
    Weight decreased
         subjects affected / exposed
    6 / 138 (4.35%)
    25 / 692 (3.61%)
    4 / 138 (2.90%)
         occurrences all number
    7
    27
    4
    Transferrin saturation decreased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pulse abnormal
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Prostatic specific antigen increased
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Polymerase chain reaction positive
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Platelet count increased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Platelet count decreased
         subjects affected / exposed
    14 / 138 (10.14%)
    59 / 692 (8.53%)
    10 / 138 (7.25%)
         occurrences all number
    20
    96
    13
    Oxygen saturation decrease
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    28 / 138 (20.29%)
    113 / 692 (16.33%)
    29 / 138 (21.01%)
         occurrences all number
    65
    289
    60
    Lymphocyte count increased
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Lymphocyte count decreased
         subjects affected / exposed
    13 / 138 (9.42%)
    45 / 692 (6.50%)
    14 / 138 (10.14%)
         occurrences all number
    17
    80
    23
    Liver palpable
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Liver function test increased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    International normalised ratio decreased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Immunoglobulins decreased
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Hypophonesis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Histamine level increased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    3
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 138 (0.72%)
    6 / 692 (0.87%)
    0 / 138 (0.00%)
         occurrences all number
    1
    8
    0
    Eosinophil count increased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Ejection fraction decreased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Coagulation time prolonged
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    3 / 138 (2.17%)
    17 / 692 (2.46%)
    2 / 138 (1.45%)
         occurrences all number
    3
    17
    2
    Body temperature increased
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Blood urea increased
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Blood sodium decreased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Blood potassium decreased
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    3
    1
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Blood magnesium decreased
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Blood iron decreased
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Blood immunoglobulin M decreased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Blood immunoglobulin G decreased
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences all number
    1
    5
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Blood folate decreased
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Blood creatinine increased
         subjects affected / exposed
    4 / 138 (2.90%)
    12 / 692 (1.73%)
    4 / 138 (2.90%)
         occurrences all number
    4
    17
    5
    Blood cholesterol increased
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    2
    3
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    4 / 138 (2.90%)
    6 / 692 (0.87%)
    0 / 138 (0.00%)
         occurrences all number
    4
    6
    0
    Infusion related reaction
         subjects affected / exposed
    4 / 138 (2.90%)
    23 / 692 (3.32%)
    3 / 138 (2.17%)
         occurrences all number
    4
    24
    3
    Head injury
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    2
    Lumbar vertebral fracture
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Muscle strain
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    Procedural pain
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    Skin abrasion
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    3
    3
    0
    Administration related reaction
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Animal bite
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Arthropod bite
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Dental restoration failure
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Fall
         subjects affected / exposed
    1 / 138 (0.72%)
    11 / 692 (1.59%)
    4 / 138 (2.90%)
         occurrences all number
    1
    12
    4
    Foot fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    3
    1
    Humerus fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    Fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    Joint dislocation
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Joint injury
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences all number
    1
    3
    2
    Ligament rupture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Ligament sprain
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    0
    3
    1
    Limb injury
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences all number
    1
    5
    0
    Muscle rupture
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Pelvic fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Post procedural haematoma
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Radiation injury
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Radiation skin injury
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Radius fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Rib fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Spinal compression fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Thermal burn
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Tooth avulsion
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Tooth fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    4
    0
    Toxicity to various agents
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Traumatic haematoma
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Upper limb fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Wrist fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Scratch
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Spinal fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural site reaction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Post-traumatic pain
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Medication error
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hand fracture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Laceration
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Epicondylitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Craniocerebral injury
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 138 (0.00%)
    10 / 692 (1.45%)
    4 / 138 (2.90%)
         occurrences all number
    0
    10
    4
    Palpitations
         subjects affected / exposed
    3 / 138 (2.17%)
    9 / 692 (1.30%)
    4 / 138 (2.90%)
         occurrences all number
    3
    11
    5
    Sinus tachycardia
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    3
    4
    0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Angina pectoris
         subjects affected / exposed
    1 / 138 (0.72%)
    7 / 692 (1.01%)
    4 / 138 (2.90%)
         occurrences all number
    1
    8
    5
    Aortic valve incompetence
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Atrial flutter
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    0
    4
    1
    Bradycardia
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Bundle branch block left
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Cardiac failure
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Extrasystoles
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperkinetic heart syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Left ventricular failure
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Myocardial ischaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Vantricular arrhythmia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Pericardial effusion
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Atrial tachycardia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Arrhythmia
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences all number
    3
    5
    0
    Atrial fibrillation
         subjects affected / exposed
    2 / 138 (1.45%)
    8 / 692 (1.16%)
    2 / 138 (1.45%)
         occurrences all number
    3
    12
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 138 (11.59%)
    68 / 692 (9.83%)
    18 / 138 (13.04%)
         occurrences all number
    24
    92
    25
    Neuropathy peripheral
         subjects affected / exposed
    8 / 138 (5.80%)
    23 / 692 (3.32%)
    7 / 138 (5.07%)
         occurrences all number
    9
    25
    8
    Dysgeusia
         subjects affected / exposed
    7 / 138 (5.07%)
    17 / 692 (2.46%)
    3 / 138 (2.17%)
         occurrences all number
    11
    21
    3
    Peripheral sensory neuropathy
         subjects affected / exposed
    4 / 138 (2.90%)
    10 / 692 (1.45%)
    3 / 138 (2.17%)
         occurrences all number
    4
    10
    3
    Presyncope
         subjects affected / exposed
    4 / 138 (2.90%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    4
    5
    1
    Amnesia
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    3
    5
    1
    Sciatica
         subjects affected / exposed
    3 / 138 (2.17%)
    12 / 692 (1.73%)
    4 / 138 (2.90%)
         occurrences all number
    3
    14
    5
    Syncope
         subjects affected / exposed
    3 / 138 (2.17%)
    10 / 692 (1.45%)
    2 / 138 (1.45%)
         occurrences all number
    3
    10
    2
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    2
    Memory impairment
         subjects affected / exposed
    2 / 138 (1.45%)
    6 / 692 (0.87%)
    2 / 138 (1.45%)
         occurrences all number
    2
    6
    2
    Ageusia
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    Aphasia
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Aphonia
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Ataxia
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Cluster headache
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Diabetic neuropathy
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Facial paralysis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Neuralgia
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    1
    4
    1
    Neuromuscular pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Nystagmus
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Parkinsonism
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Parosmia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Polyneuropathy
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    Sensorimotor disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Tremor
         subjects affected / exposed
    3 / 138 (2.17%)
    13 / 692 (1.88%)
    3 / 138 (2.17%)
         occurrences all number
    3
    15
    4
    Tension headache
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Somnolence
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    3 / 138 (2.17%)
         occurrences all number
    0
    4
    3
    Sensory disturbance
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Seizure
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    1
    5
    2
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    5 / 138 (3.62%)
    29 / 692 (4.19%)
    9 / 138 (6.52%)
         occurrences all number
    5
    29
    9
    Nerve root compression
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Nerve compression
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Lethargy
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences all number
    2
    5
    0
    Intention tremor
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hypotonia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hypokinesia
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 138 (0.72%)
    6 / 692 (0.87%)
    2 / 138 (1.45%)
         occurrences all number
    1
    8
    3
    Hypersomnia
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Hemiparesis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Formication
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Facial neuralgia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Dysgraphia
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Dysaesthesia
         subjects affected / exposed
    1 / 138 (0.72%)
    6 / 692 (0.87%)
    3 / 138 (2.17%)
         occurrences all number
    1
    6
    3
    Dizziness
         subjects affected / exposed
    16 / 138 (11.59%)
    36 / 692 (5.20%)
    8 / 138 (5.80%)
         occurrences all number
    21
    42
    8
    Disturbance in attention
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Cerebral microangiopathy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Carpal tunnel syndrome
         subjects affected / exposed
    3 / 138 (2.17%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    3
    3
    0
    Burning sensation
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Balance disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences all number
    1
    3
    2
    Arachnoid cyst
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Anosmia
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    48 / 138 (34.78%)
    226 / 692 (32.66%)
    51 / 138 (36.96%)
         occurrences all number
    134
    604
    173
    Anaemia
         subjects affected / exposed
    23 / 138 (16.67%)
    106 / 692 (15.32%)
    21 / 138 (15.22%)
         occurrences all number
    35
    172
    32
    Leukopenia
         subjects affected / exposed
    14 / 138 (10.14%)
    52 / 692 (7.51%)
    9 / 138 (6.52%)
         occurrences all number
    47
    126
    18
    Lymphopenia
         subjects affected / exposed
    4 / 138 (2.90%)
    16 / 692 (2.31%)
    1 / 138 (0.72%)
         occurrences all number
    13
    34
    1
    Febrile neutropenia
         subjects affected / exposed
    3 / 138 (2.17%)
    15 / 692 (2.17%)
    2 / 138 (1.45%)
         occurrences all number
    3
    22
    8
    Lymphadenopathy
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    3 / 138 (2.17%)
         occurrences all number
    0
    3
    3
    Agranulocytosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    3 / 138 (2.17%)
         occurrences all number
    0
    1
    3
    Haematotoxicity
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Pancytopenia
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    0
    4
    1
    Thrombocytopenia
         subjects affected / exposed
    9 / 138 (6.52%)
    49 / 692 (7.08%)
    10 / 138 (7.25%)
         occurrences all number
    12
    75
    13
    Microcytosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Lymphocytosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Leukocytosis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Lymph node pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoglobulinaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hypochromic anaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Eosinophilia
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences all number
    0
    4
    0
    Coagulopathy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    7 / 138 (5.07%)
    18 / 692 (2.60%)
    2 / 138 (1.45%)
         occurrences all number
    10
    21
    2
    Tinnitus
         subjects affected / exposed
    5 / 138 (3.62%)
    9 / 692 (1.30%)
    2 / 138 (1.45%)
         occurrences all number
    6
    10
    2
    Ear pain
         subjects affected / exposed
    4 / 138 (2.90%)
    11 / 692 (1.59%)
    2 / 138 (1.45%)
         occurrences all number
    4
    12
    2
    Deafness unilateral
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences all number
    0
    3
    2
    Deafness
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Hypoacusis
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    1
    4
    1
    Tympanic membrane disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Vestibular disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Middle ear inflammation
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    4 / 138 (2.90%)
    6 / 692 (0.87%)
    0 / 138 (0.00%)
         occurrences all number
    4
    6
    0
    Dry eye
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences all number
    3
    5
    0
    Cataract
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    3
    5
    2
    Vision blurred
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    2
    5
    1
    Visual impairment
         subjects affected / exposed
    2 / 138 (1.45%)
    6 / 692 (0.87%)
    1 / 138 (0.72%)
         occurrences all number
    2
    6
    1
    Chalazion
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Diabetic retinopathy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Eye inflammation
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Eye irritation
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Eye pruritus
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences all number
    1
    3
    2
    Eyelid oedema
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Glaucoma
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Noninfective conjunctivitis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    0
    3
    1
    Periorbital oedema
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Visual acuity reduced
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Vitreous floaters
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Eyelid swelling
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Eye discharge
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Entropion
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    45 / 138 (32.61%)
    199 / 692 (28.76%)
    37 / 138 (26.81%)
         occurrences all number
    63
    312
    65
    Diarrhoea
         subjects affected / exposed
    35 / 138 (25.36%)
    143 / 692 (20.66%)
    28 / 138 (20.29%)
         occurrences all number
    50
    211
    36
    Vomiting
         subjects affected / exposed
    23 / 138 (16.67%)
    96 / 692 (13.87%)
    15 / 138 (10.87%)
         occurrences all number
    32
    160
    22
    Constipation
         subjects affected / exposed
    21 / 138 (15.22%)
    98 / 692 (14.16%)
    15 / 138 (10.87%)
         occurrences all number
    26
    129
    22
    Abdominal pain
         subjects affected / exposed
    13 / 138 (9.42%)
    57 / 692 (8.24%)
    13 / 138 (9.42%)
         occurrences all number
    15
    74
    23
    Abdominal pain upper
         subjects affected / exposed
    11 / 138 (7.97%)
    39 / 692 (5.64%)
    4 / 138 (2.90%)
         occurrences all number
    16
    49
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    11 / 138 (7.97%)
    20 / 692 (2.89%)
    7 / 138 (5.07%)
         occurrences all number
    13
    24
    9
    Dyspepsia
         subjects affected / exposed
    10 / 138 (7.25%)
    26 / 692 (3.76%)
    7 / 138 (5.07%)
         occurrences all number
    10
    27
    7
    Stomatitis
         subjects affected / exposed
    5 / 138 (3.62%)
    17 / 692 (2.46%)
    3 / 138 (2.17%)
         occurrences all number
    5
    18
    4
    Toothache
         subjects affected / exposed
    5 / 138 (3.62%)
    9 / 692 (1.30%)
    2 / 138 (1.45%)
         occurrences all number
    5
    9
    2
    Aphthous ulcer
         subjects affected / exposed
    0 / 138 (0.00%)
    6 / 692 (0.87%)
    3 / 138 (2.17%)
         occurrences all number
    0
    6
    3
    Colitis
         subjects affected / exposed
    3 / 138 (2.17%)
    6 / 692 (0.87%)
    0 / 138 (0.00%)
         occurrences all number
    5
    8
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 138 (0.00%)
    12 / 692 (1.73%)
    3 / 138 (2.17%)
         occurrences all number
    0
    12
    3
    Mouth ulceration
         subjects affected / exposed
    3 / 138 (2.17%)
    12 / 692 (1.73%)
    3 / 138 (2.17%)
         occurrences all number
    4
    15
    4
    Oral pain
         subjects affected / exposed
    3 / 138 (2.17%)
    15 / 692 (2.17%)
    5 / 138 (3.62%)
         occurrences all number
    3
    16
    5
    Abdominal discomfort
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    0
    5
    2
    Abdominal distension
         subjects affected / exposed
    2 / 138 (1.45%)
    7 / 692 (1.01%)
    1 / 138 (0.72%)
         occurrences all number
    2
    8
    1
    Enterocolitis
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Gastrointestinal disorder
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    2
    5
    2
    Hiatus hernia
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    2
    4
    1
    Inguinal hernia
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    Irritable bowel syndrome
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Oesophagitis
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Tongue ulceration
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    2 / 138 (1.45%)
         occurrences all number
    0
    4
    2
    Tooth disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    2
    Umbilical hernia
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Abdominal pain lower
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    3
    2
    Abdominal tenderness
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    0
    3
    1
    Crohn's disease
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    2
    Diverticulum intestinal
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Dry mouth
         subjects affected / exposed
    1 / 138 (0.72%)
    10 / 692 (1.45%)
    1 / 138 (0.72%)
         occurrences all number
    1
    10
    1
    Dysphagia
         subjects affected / exposed
    1 / 138 (0.72%)
    10 / 692 (1.45%)
    1 / 138 (0.72%)
         occurrences all number
    1
    10
    1
    Eructation
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Faecaloma
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Faeces soft
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 138 (0.72%)
    7 / 692 (1.01%)
    1 / 138 (0.72%)
         occurrences all number
    1
    7
    1
    Gastritis
         subjects affected / exposed
    1 / 138 (0.72%)
    12 / 692 (1.73%)
    6 / 138 (4.35%)
         occurrences all number
    1
    12
    6
    Gastrointestinal hypomotility
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Gingival bleeding
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Haematochezia
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences all number
    1
    3
    2
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    0
    4
    1
    Haemorrhoids thrombosed
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Ileal ulcer
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Melaena
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Noninfective gingivitis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Odynophagia
         subjects affected / exposed
    1 / 138 (0.72%)
    7 / 692 (1.01%)
    2 / 138 (1.45%)
         occurrences all number
    1
    10
    5
    Pancreatic cyst
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Proctalgia
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Rectal polyp
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Sensitivity of teeth
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Tongue coated
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Tongue geographic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Tooth loss
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Ascites
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    0
    4
    0
    Anal fissure
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    3
    0
    Paraesthesia oral
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    0
    3
    0
    Gastric ulcer
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Lip ulceration
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Anal haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Change in bowel habit
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Chronic gastritis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth development disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Salivary hypersecretion
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Perianal erythema
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pancreatic duct dilatation
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Oral disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Large intestinal ulcer
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Intestinal obstruction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal toxicity
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Food poisoning
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Dyschezia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Defaecation urgency
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    19 / 138 (13.77%)
    76 / 692 (10.98%)
    18 / 138 (13.04%)
         occurrences all number
    24
    97
    23
    Pruritus
         subjects affected / exposed
    11 / 138 (7.97%)
    51 / 692 (7.37%)
    9 / 138 (6.52%)
         occurrences all number
    14
    61
    12
    Alopecia
         subjects affected / exposed
    6 / 138 (4.35%)
    23 / 692 (3.32%)
    6 / 138 (4.35%)
         occurrences all number
    6
    26
    7
    Erythema
         subjects affected / exposed
    6 / 138 (4.35%)
    29 / 692 (4.19%)
    6 / 138 (4.35%)
         occurrences all number
    7
    39
    7
    Eczema
         subjects affected / exposed
    3 / 138 (2.17%)
    12 / 692 (1.73%)
    4 / 138 (2.90%)
         occurrences all number
    3
    14
    4
    Hyperhidrosis
         subjects affected / exposed
    3 / 138 (2.17%)
    15 / 692 (2.17%)
    2 / 138 (1.45%)
         occurrences all number
    3
    15
    2
    Night sweats
         subjects affected / exposed
    3 / 138 (2.17%)
    19 / 692 (2.75%)
    3 / 138 (2.17%)
         occurrences all number
    5
    22
    4
    Skin lesion
         subjects affected / exposed
    3 / 138 (2.17%)
    19 / 692 (2.75%)
    7 / 138 (5.07%)
         occurrences all number
    3
    22
    8
    Urticaria
         subjects affected / exposed
    3 / 138 (2.17%)
    15 / 692 (2.17%)
    2 / 138 (1.45%)
         occurrences all number
    3
    20
    7
    Actinic keratosis
         subjects affected / exposed
    2 / 138 (1.45%)
    10 / 692 (1.45%)
    3 / 138 (2.17%)
         occurrences all number
    2
    11
    3
    Hyperkeratosis
         subjects affected / exposed
    2 / 138 (1.45%)
    8 / 692 (1.16%)
    2 / 138 (1.45%)
         occurrences all number
    2
    8
    2
    Psoriasis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    2
    Purpura
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 692 (0.58%)
    2 / 138 (1.45%)
         occurrences all number
    2
    4
    2
    Rash erythematous
         subjects affected / exposed
    2 / 138 (1.45%)
    7 / 692 (1.01%)
    1 / 138 (0.72%)
         occurrences all number
    2
    7
    1
    Angioedema
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Dermatitis bullous
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    4
    4
    0
    Granulomatous rosacea
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Neurodermatitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Panniculitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Pityriasis rosea
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Rash follicular
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Rash macular
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Rosacea
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    5
    3
    Skin exfoliation
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Skin reaction
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    1
    6
    2
    Swelling face
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Stasis dermatitis
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    3
    1
    Skin ulcer
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    3 / 138 (2.17%)
         occurrences all number
    1
    4
    3
    Skin swelling
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Skin mass
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Skin disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Sebaceous hyperplasia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    0
    3
    0
    Rash papular
         subjects affected / exposed
    0 / 138 (0.00%)
    6 / 692 (0.87%)
    1 / 138 (0.72%)
         occurrences all number
    0
    8
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 138 (0.00%)
    8 / 692 (1.16%)
    2 / 138 (1.45%)
         occurrences all number
    0
    10
    3
    Rash generalised
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus generalised
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    1
    4
    1
    Pruritus allergic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Prurigo
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Perioral dermatitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pain of skin
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Nail discolouration
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Macule
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Intertrigo
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    2
    Hypertrichiosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Exfoliative rash
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema nodosum
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Erythema multiforme
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Eczema nummular
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Ecchymosis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Dry skin
         subjects affected / exposed
    4 / 138 (2.90%)
    10 / 692 (1.45%)
    3 / 138 (2.17%)
         occurrences all number
    5
    11
    3
    Drug eruption
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences all number
    1
    5
    0
    Dermatomyositis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Dermatitis allergic
         subjects affected / exposed
    2 / 138 (1.45%)
    6 / 692 (0.87%)
    2 / 138 (1.45%)
         occurrences all number
    2
    6
    2
    Dermatitis
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    2
    5
    2
    Dermal cyst
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Decubitus ulcer
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Blood blister
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Acne
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    3 / 138 (2.17%)
    9 / 692 (1.30%)
    1 / 138 (0.72%)
         occurrences all number
    3
    10
    1
    Dysuria
         subjects affected / exposed
    2 / 138 (1.45%)
    13 / 692 (1.88%)
    6 / 138 (4.35%)
         occurrences all number
    2
    14
    6
    Haematuria
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    2
    5
    1
    Renal failure
         subjects affected / exposed
    0 / 138 (0.00%)
    8 / 692 (1.16%)
    2 / 138 (1.45%)
         occurrences all number
    0
    9
    2
    Strangury
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences all number
    0
    3
    2
    Azotaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Bladder disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Bladder hypertrophy
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Chronic kidney disease
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Hypertonic bladder
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Nephroangiosclerosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Nephrolithiasis
         subjects affected / exposed
    1 / 138 (0.72%)
    6 / 692 (0.87%)
    3 / 138 (2.17%)
         occurrences all number
    1
    6
    3
    Nocturia
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Renal colic
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Urethral haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    1
    7
    3
    Urinary tract obstruction
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Urinary tract pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary retention
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    3
    5
    1
    Renal pain
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Renal impairment
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Renal cyst
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences all number
    1
    3
    2
    Renal atrophy
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Polyuria
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Micturition urgency
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Leukocyturia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    0
    3
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    5 / 138 (3.62%)
    16 / 692 (2.31%)
    5 / 138 (3.62%)
         occurrences all number
    5
    17
    5
    Osteoporosis
         subjects affected / exposed
    4 / 138 (2.90%)
    7 / 692 (1.01%)
    1 / 138 (0.72%)
         occurrences all number
    4
    8
    1
    Spinal osteoarthritis
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    2
    4
    1
    Chondrocalcinosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Exostosis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Limb mass
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Muscle tightness
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Muscular weakness
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Osteopenia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Periostitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Sjogren's syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Spinal column stenosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Spinal pain
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences all number
    1
    4
    0
    Tenosynovitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Tendonitis
         subjects affected / exposed
    3 / 138 (2.17%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    3
    4
    1
    Tendon disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Synovial cyst
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Spondylitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Periarthritis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Polyarthritis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in jaw
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    2
    Pain in extremity
         subjects affected / exposed
    10 / 138 (7.25%)
    43 / 692 (6.21%)
    10 / 138 (7.25%)
         occurrences all number
    10
    46
    11
    Osteochondrosis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Osteoarthritis
         subjects affected / exposed
    3 / 138 (2.17%)
    14 / 692 (2.02%)
    5 / 138 (3.62%)
         occurrences all number
    3
    15
    5
    Osteitis deformans
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Neck pain
         subjects affected / exposed
    4 / 138 (2.90%)
    11 / 692 (1.59%)
    3 / 138 (2.17%)
         occurrences all number
    5
    12
    3
    Myofascial pain syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Musculoskeletal pain
         subjects affected / exposed
    5 / 138 (3.62%)
    22 / 692 (3.18%)
    6 / 138 (4.35%)
         occurrences all number
    5
    22
    6
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    2
    5
    2
    Muscle spasms
         subjects affected / exposed
    10 / 138 (7.25%)
    25 / 692 (3.61%)
    5 / 138 (3.62%)
         occurrences all number
    10
    28
    7
    Muscle fatigue
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Muscle contracture
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Mobility decreased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Joint swelling
         subjects affected / exposed
    2 / 138 (1.45%)
    7 / 692 (1.01%)
    3 / 138 (2.17%)
         occurrences all number
    3
    8
    3
    Limb discomfort
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Joint stiffness
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Groin pain
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    4
    2
    Foot deformity
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Flank pain
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    1
    6
    1
    Bursitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Bone pain
         subjects affected / exposed
    2 / 138 (1.45%)
    17 / 692 (2.46%)
    3 / 138 (2.17%)
         occurrences all number
    2
    17
    3
    Back pain
         subjects affected / exposed
    14 / 138 (10.14%)
    62 / 692 (8.96%)
    13 / 138 (9.42%)
         occurrences all number
    16
    72
    19
    Axillary mass
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Arthritis
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    0
    5
    2
    Arthralgia
         subjects affected / exposed
    15 / 138 (10.87%)
    52 / 692 (7.51%)
    14 / 138 (10.14%)
         occurrences all number
    22
    68
    23
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    29 / 138 (21.01%)
    72 / 692 (10.40%)
    24 / 138 (17.39%)
         occurrences all number
    55
    120
    36
    Bronchitis
         subjects affected / exposed
    24 / 138 (17.39%)
    78 / 692 (11.27%)
    21 / 138 (15.22%)
         occurrences all number
    55
    126
    27
    Upper respiratory tract infection
         subjects affected / exposed
    24 / 138 (17.39%)
    63 / 692 (9.10%)
    20 / 138 (14.49%)
         occurrences all number
    36
    85
    26
    Influenza
         subjects affected / exposed
    20 / 138 (14.49%)
    56 / 692 (8.09%)
    14 / 138 (10.14%)
         occurrences all number
    23
    65
    18
    Rhinitis
         subjects affected / exposed
    19 / 138 (13.77%)
    42 / 692 (6.07%)
    9 / 138 (6.52%)
         occurrences all number
    21
    46
    9
    Lower respiratory tract infection
         subjects affected / exposed
    17 / 138 (12.32%)
    46 / 692 (6.65%)
    9 / 138 (6.52%)
         occurrences all number
    37
    76
    14
    Pneumonia
         subjects affected / exposed
    17 / 138 (12.32%)
    44 / 692 (6.36%)
    10 / 138 (7.25%)
         occurrences all number
    22
    55
    13
    Herpes zoster
         subjects affected / exposed
    16 / 138 (11.59%)
    46 / 692 (6.65%)
    12 / 138 (8.70%)
         occurrences all number
    18
    50
    12
    Sinusitis
         subjects affected / exposed
    14 / 138 (10.14%)
    45 / 692 (6.50%)
    16 / 138 (11.59%)
         occurrences all number
    27
    67
    21
    Conjunctivitis
         subjects affected / exposed
    12 / 138 (8.70%)
    24 / 692 (3.47%)
    4 / 138 (2.90%)
         occurrences all number
    14
    27
    5
    Urinary tract infection
         subjects affected / exposed
    11 / 138 (7.97%)
    55 / 692 (7.95%)
    14 / 138 (10.14%)
         occurrences all number
    14
    73
    22
    Lung infection
         subjects affected / exposed
    10 / 138 (7.25%)
    24 / 692 (3.47%)
    5 / 138 (3.62%)
         occurrences all number
    15
    32
    5
    Oral herpes
         subjects affected / exposed
    9 / 138 (6.52%)
    25 / 692 (3.61%)
    4 / 138 (2.90%)
         occurrences all number
    17
    35
    5
    Viral infection
         subjects affected / exposed
    7 / 138 (5.07%)
    11 / 692 (1.59%)
    2 / 138 (1.45%)
         occurrences all number
    8
    12
    2
    Acute sinusitis
         subjects affected / exposed
    5 / 138 (3.62%)
    7 / 692 (1.01%)
    1 / 138 (0.72%)
         occurrences all number
    6
    7
    1
    Cystitis
         subjects affected / exposed
    4 / 138 (2.90%)
    6 / 692 (0.87%)
    0 / 138 (0.00%)
         occurrences all number
    4
    6
    0
    Respiratory tract infection
         subjects affected / exposed
    4 / 138 (2.90%)
    24 / 692 (3.47%)
    10 / 138 (7.25%)
         occurrences all number
    5
    36
    19
    Tracheobronchitis
         subjects affected / exposed
    4 / 138 (2.90%)
    6 / 692 (0.87%)
    1 / 138 (0.72%)
         occurrences all number
    4
    6
    1
    Candida infection
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences all number
    3
    5
    0
    Ear infection
         subjects affected / exposed
    3 / 138 (2.17%)
    14 / 692 (2.02%)
    4 / 138 (2.90%)
         occurrences all number
    4
    17
    4
    Oral candidiasis
         subjects affected / exposed
    3 / 138 (2.17%)
    14 / 692 (2.02%)
    3 / 138 (2.17%)
         occurrences all number
    3
    15
    4
    Pharyngitis
         subjects affected / exposed
    3 / 138 (2.17%)
    9 / 692 (1.30%)
    3 / 138 (2.17%)
         occurrences all number
    4
    13
    6
    Pulpitis dental
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    3 / 138 (2.17%)
         occurrences all number
    0
    6
    3
    Tonsillitis
         subjects affected / exposed
    3 / 138 (2.17%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    3
    6
    3
    Tracheitis
         subjects affected / exposed
    3 / 138 (2.17%)
    8 / 692 (1.16%)
    3 / 138 (2.17%)
         occurrences all number
    3
    8
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 138 (2.17%)
    7 / 692 (1.01%)
    0 / 138 (0.00%)
         occurrences all number
    3
    7
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 138 (1.45%)
    11 / 692 (1.59%)
    7 / 138 (5.07%)
         occurrences all number
    2
    12
    7
    Gastrointestinal infection
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    2
    3
    1
    Gingivitis
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    3
    6
    2
    Herpes simplex
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    2
    4
    1
    Hordeolum
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    3
    3
    0
    Laryngitis
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences all number
    2
    4
    0
    Onychomycosis
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    2
    5
    2
    Oral fungal infection
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    2
    6
    2
    Oral infection
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    2
    4
    0
    Subcutaneous abscess
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    2
    9
    6
    Tooth abscess
         subjects affected / exposed
    2 / 138 (1.45%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    2
    5
    1
    Vaginal infection
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    3
    4
    1
    Viral pharyngitis
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    Anal abscess
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Angular cheilitis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Arthritis bacterial
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Bacterial infection
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Blastocystis infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Bartholinitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Body tinea
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Campylobacter colitis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Campylobacter infection
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Cellulitis
         subjects affected / exposed
    1 / 138 (0.72%)
    8 / 692 (1.16%)
    2 / 138 (1.45%)
         occurrences all number
    1
    9
    2
    Chlamydial infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Dacryocanaliculitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Device related infection
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Device related sepsis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Diverticulitis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Erysipelas
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    2 / 138 (1.45%)
         occurrences all number
    1
    4
    2
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    2
    8
    4
    Eye infection
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    0
    3
    1
    Eyelid infection
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Folliculitis
         subjects affected / exposed
    1 / 138 (0.72%)
    8 / 692 (1.16%)
    2 / 138 (1.45%)
         occurrences all number
    1
    12
    5
    Fungal infection
         subjects affected / exposed
    1 / 138 (0.72%)
    6 / 692 (0.87%)
    1 / 138 (0.72%)
         occurrences all number
    1
    6
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences all number
    2
    5
    3
    Furuncle
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    1
    7
    4
    Gastroenteritis viral
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Genital herpes simplex
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Haemophilus infection
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Helicobacter gastritis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Hepatitis B
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Hepatitis viral
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Herpes virus infection
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    4
    2
    Infected bite
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Infection
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    1
    4
    1
    Infectious colitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Injection site cellulitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Labyrinthitis
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    Lip infection
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Lymphangitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Mucosal infection
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Nail infection
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Otitis externa
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    2
    Otitis media
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Periorbital infection
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Pertussis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    Pneumonia bacterial
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Pneumonia fungal
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Postoperative wound infection
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Proteus infection
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    3
    3
    0
    Rash pustular
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    1 / 138 (0.72%)
         occurrences all number
    1
    5
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Skin infection
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    3 / 138 (2.17%)
         occurrences all number
    1
    4
    3
    Staphylococcal infection
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    Tinea pedis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Tooth infection
         subjects affected / exposed
    1 / 138 (0.72%)
    5 / 692 (0.72%)
    2 / 138 (1.45%)
         occurrences all number
    2
    6
    2
    Trichomoniasis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Varicella zoster virus infection
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    Viral parotitis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Vulvitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    3
    5
    2
    Wound infection
         subjects affected / exposed
    1 / 138 (0.72%)
    3 / 692 (0.43%)
    2 / 138 (1.45%)
         occurrences all number
    1
    3
    2
    Bacteuria
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Ureaplasma infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis bacterial
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Superinfection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Sepsis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Rectal abscess
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pyoderma
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Puncture site abscess
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pseudomonas infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Pseudomembranous colitis
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Paronychia
         subjects affected / exposed
    0 / 138 (0.00%)
    3 / 692 (0.43%)
    0 / 138 (0.00%)
         occurrences all number
    0
    6
    0
    Orchitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal herpes
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Meningitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes zoster oticus
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes zoster infection neurological
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic infection fungal
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal fungal infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Endocarditis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis Escherichia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Balanitis candida
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Arthritis infective
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Application site cellulitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Abscess oral
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    3 / 138 (2.17%)
    7 / 692 (1.01%)
    3 / 138 (2.17%)
         occurrences all number
    3
    7
    3
    Hyperkalaemia
         subjects affected / exposed
    2 / 138 (1.45%)
    6 / 692 (0.87%)
    0 / 138 (0.00%)
         occurrences all number
    3
    8
    0
    Hypophosphataemia
         subjects affected / exposed
    2 / 138 (1.45%)
    7 / 692 (1.01%)
    0 / 138 (0.00%)
         occurrences all number
    2
    9
    0
    Dyslipidaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 138 (0.72%)
    4 / 692 (0.58%)
    0 / 138 (0.00%)
         occurrences all number
    1
    5
    0
    Increased appetite
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Metabolic acidosis
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    2 / 138 (1.45%)
    4 / 692 (0.58%)
    1 / 138 (0.72%)
         occurrences all number
    2
    4
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Tetany
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Obesity
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    1
    Metabolic disorder
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    Malnutrition
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Lactose intolerance
         subjects affected / exposed
    2 / 138 (1.45%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    2
    0
    Iron deficiency
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    Hypovitaminosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hypouricaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoproteinaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Hypophagia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    6 / 692 (0.87%)
    1 / 138 (0.72%)
         occurrences all number
    0
    9
    1
    Hypokalaemia
         subjects affected / exposed
    7 / 138 (5.07%)
    22 / 692 (3.18%)
    1 / 138 (0.72%)
         occurrences all number
    10
    31
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences all number
    0
    7
    0
    Hypoalbminaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 692 (0.72%)
    0 / 138 (0.00%)
         occurrences all number
    0
    5
    0
    Hyperuricaemia
         subjects affected / exposed
    6 / 138 (4.35%)
    10 / 692 (1.45%)
    3 / 138 (2.17%)
         occurrences all number
    9
    13
    3
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 138 (1.45%)
    3 / 692 (0.43%)
    1 / 138 (0.72%)
         occurrences all number
    2
    3
    1
    Hyperphosphataemia
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Hypernatraemia
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 692 (0.29%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    2 / 138 (1.45%)
    8 / 692 (1.16%)
    2 / 138 (1.45%)
         occurrences all number
    5
    11
    2
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 138 (0.00%)
    4 / 692 (0.58%)
    2 / 138 (1.45%)
         occurrences all number
    0
    4
    2
    Hypercalcaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    6 / 692 (0.87%)
    1 / 138 (0.72%)
         occurrences all number
    1
    6
    1
    Gout
         subjects affected / exposed
    2 / 138 (1.45%)
    6 / 692 (0.87%)
    1 / 138 (0.72%)
         occurrences all number
    2
    6
    1
    Folate deficiency
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    Fluid retention
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Fluid overload
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    Decreased appetite
         subjects affected / exposed
    7 / 138 (5.07%)
    48 / 692 (6.94%)
    7 / 138 (5.07%)
         occurrences all number
    9
    56
    9
    Cachexia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 692 (0.14%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jul 2012
    1. Eligibility criteria: - to clarify that study treatment was second-line therapy, subjects who only relapsed or been refractory to prior radiotherapy were eligible for the study; - subjects with SD were no longer considered eligible to enter Prolonged Maintenance (Maintenance II phase) as they were not expected to receive clinical benefit; - to make the pathological evaluation easier, other not further classified low malignant lymphoma by IHC was removed as part of the inclusion criteria; - subjects with documented Gilbert disease were allowed to be enrolled if total bilirubin was </= 3.0 x ULN. 2. Study Outcomes: - to differentiate overall survival as calculated from the beginning of Induction treatment with rituximab, to the overall survival calculated from the time of randomization to rituximab SC vs observation, overall survival was separated into OSregist (measured from the first Induction dose of rituximab) and OSrand (measured from the time of randomization); - to correct an error that partial response (PR) to complete response (CR) conversion rate was measured only at the end of Maintenance I; - to correct an error that the staging assessment done post-Maintenance I was compared with the subject’s baseline status; - clarification that overall response rate was measured from the first dose of rituximab induction to the end of the Induction Phase; - response assessments were to be made according to the recommendations for Waldenstrom’s macroglobulinemia; - the exploratory analysis was to be completed earlier to support submission; - for all secondary efficacy analyses, descriptive statistics and Kaplan-Meier curves were to be presented for non-randomized subjects and for the two randomized treatment groups.
    26 Jul 2012
    3. Study Assessments: - CT scans were done with contrast including neck to properly evaluate follicular lymphoma; - other diagnostic means were acceptable to properly evaluate gastric lymphoma; - Rituximab Administration Satisfaction Questionnaire (RASQ) replaced Cancer Therapy Satisfaction Questionnaire (CTSQ); - bone marrow assessments were required at baseline; - correction of Schedule of Assessments to include survival; - Off-Treatment Follow-Up added in the Schedule of Assessments. 4. Study Treatment: - the time window for the SC rituximab injection broadened to approximately 5 to 7 minutes; - SC rituximab not be withdrawn from the vial until the time of administration; - to follow normal medical practice on the observation period after SC rituximab injection; - IV rituximab dose could be round to the nearest 10 mg; - details of preparation and administration of SC rituximab and IV rituximab were removed from the protocol and provided in a separate Guidance Document; - the timing details of rituximab with respect to chemotherapy were clarified; - the dosages of prophylactic premedication are no longer specified; - only commercially available chemotherapy was allowed. 5. Study Design: - study timelines were modified for the enrollment period, the randomization period and for the total study duration; - the enrolment period was extended to 24 months; - the required number of events were adjusted for the log-rank test; - the definition of the end of study was revised. 6. Changes for Safety: - timing of SAE collection; - SAE reporting time frame to follow Sponsor’s standard procedure; - clarification of SAE reporting requirements; - pregnancy was to be reported within 12 months after stopping study treatment; - Independent Data Monitoring Committee (IDMC) replaced the Data Safety Monitoring Board (DSMB); - interim safety analysis was added; - introducing the term “infusion/injection-related reactions”. 7. Administrative changes
    23 Sep 2012
    - The sentence “or other not further classified low malignant lymphoma by immunohistochemistry” was consistently removed from the protocol v3.0; - “Infusion/injection-related reactions (IRRs)” was redefined as “infusion/administration-related reactions (IRRs/ARRs)”; - Clarification that the 1999 version of the International Working Group (Cheson) Criteria for Evaluation of Response in Non-Hodgkin’s Lymphoma was to be used (which does not use PET), NOT the revised 2007 criteria; - More details were added to Appendix 2; Criteria for the Evaluation of Response in Waldenström’s macroglobulinemia; - Specified that subjects in Arm A (Maintenance II) should continue treatment with rituximab SC until disease progression, unacceptable toxicity, withdrawal of subject consent or End of Study (EOS), whichever occurs first; - Permitted windows for delays in the administration of Treatment were included due to toxicity reasons; - Clarification about FLIPI as a standardized guide on prognosis of survival rates only for Follicular Lymphoma subjects; - Addition of the Cancer Therapy Satisfaction Questionnaire (CTSQ) as a tool for assessing subject preference; - After discontinuation of study treatment, subjects were to be followed-up until the end of the whole study for resolution of all SAEs related to rituximab maintenance therapy
    06 Jul 2017
    The AE and SAE reporting duration was clarified. Additional minor changes have been made to improve clarity and consistency: -The end of study section in the synopsis of protocol was revised to clarify that maintenance II arm B patients were expected to follow the same schedule of assessment as patients on arm A; - New medical contact and statistician names were added to the Protocol; - The number of subjects section was updated to reflect the final number of subjects randomized to maintenance II therapy and the enrolment time line; - Relevant sections were revised to remove the reference to stable disease at the end of maintenance I; - Clarification was added that the trial could be stopped if the 129th PFS event was reported; - In the relevant table the footnote link was corrected; - In the relevant section and table, clarification was added regarding the movement of subjects in to off-treatment follow-up following the end of treatment or their participation in maintenance II arm B; - In the relevant section, the guidance to record and assess the individual symptoms of infusion related reactions and administration related reactions was removed; - Spelling errors were corrected.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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