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    Clinical Trial Results:
    A Phase I/II Multi-centre Study of AZD8931 in Combination with Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Solid Tumours and in a Selected Population with Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer (THYME)

    Summary
    EudraCT number
    2009-010551-26
    Trial protocol
    GB   CZ   HU   SE   FR   IT   BG   BE  
    Global end of trial date
    05 Feb 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Apr 2016
    First version publication date
    23 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D0102C00003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Astrazeneca
    Sponsor organisation address
    Macclesfield, Cheshire, United Kingdom, SK10 4TG
    Public contact
    Dr Serban Ghiorghiu, Astrazeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Dr Serban Ghiorghiu, Astrazeneca, ClinicalTrialTransparency@astrazeneca.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
    11 Apr 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Apr 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the progression free survival (PFS) in patients treated with AZD8931 in combination with weekly paclitaxel versus weekly paclitaxel alone
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Jun 2009
    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
    Belgium: 13
    Country: Number of subjects enrolled
    Brazil: 33
    Country: Number of subjects enrolled
    Bulgaria: 11
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Czech Republic: 18
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Hungary: 19
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Panama: 4
    Country: Number of subjects enrolled
    Peru: 25
    Country: Number of subjects enrolled
    Spain: 41
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Switzerland: 3
    Country: Number of subjects enrolled
    United Kingdom: 21
    Worldwide total number of subjects
    210
    EEA total number of subjects
    137
    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)
    173
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Phase I: 20 patients enrolled, 6 to AZD8931 160mg, 2 to AZD8931 120 mg, 6 to AZD8931 80 mg and 6 to AZD8931 40mg. Phase II: 305 enrolled, 190 randomised, 94 and 96 allocated to AZD8931 40mg + Paclitaxel and Placebo + Paclitaxel respectively. Enrolled patients differs slightly from protocol as focus was on achieving number to be randomised.

    Pre-assignment
    Screening details
    Phase I: 20 patients enrolled, 6 to AZD8931 160mg, 2 to AZD8931 120 mg, 6 to AZD8931 80 mg and 6 to AZD8931 40mg. Phase II: 305 enrolled, 190 randomised, 94 and 96 allocated to AZD8931 40mg + Paclitaxel and Placebo + Paclitaxel respectively. Enrolled patients differs slightly from protocol as focus was on achieving number to be randomised.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    Part A not blinded. Part B blinded , 1:1 randomisation

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    AZD8931 160 mg bd
    Arm description
    Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
    Arm type
    Experimental

    Investigational medicinal product name
    AZD8931
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    160mg bd

    Arm title
    AZD8931 120 mg bd
    Arm description
    Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
    Arm type
    Experimental

    Investigational medicinal product name
    AZD8931
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    120mg bd

    Arm title
    AZD8931 80 mg bd
    Arm description
    Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
    Arm type
    Experimental

    Investigational medicinal product name
    AZD8931
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    80mg bd

    Arm title
    AZD8931 40 mg bd
    Arm description
    Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
    Arm type
    Experimental

    Investigational medicinal product name
    AZD8931
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40mg bd

    Arm title
    AZD8931 40MG bd + Paclitaxel
    Arm description
    Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
    Arm type
    Experimental

    Investigational medicinal product name
    AZD8931
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    AZD8931 40mg bd

    Arm title
    Placebo + Paclitaxel
    Arm description
    Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    placebo to match bd

    Number of subjects in period 1
    AZD8931 160 mg bd AZD8931 120 mg bd AZD8931 80 mg bd AZD8931 40 mg bd AZD8931 40MG bd + Paclitaxel Placebo + Paclitaxel
    Started
    6
    2
    6
    6
    94
    96
    Completed
    0
    0
    0
    0
    65
    70
    Not completed
    6
    2
    6
    6
    29
    26
         Adverse event, serious fatal
             -
             -
             -
             -
             28
             24
         Adverse event, non-fatal
             1
             2
             -
             3
             -
             -
         Consent withdrawn by subject
             1
             -
             1
             -
             1
             2
         Condition under investigation worsened
             4
             -
             5
             3
             -
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD8931 160 mg bd
    Reporting group description
    Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group title
    AZD8931 120 mg bd
    Reporting group description
    Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group title
    AZD8931 80 mg bd
    Reporting group description
    Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group title
    AZD8931 40 mg bd
    Reporting group description
    Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group title
    AZD8931 40MG bd + Paclitaxel
    Reporting group description
    Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group title
    Placebo + Paclitaxel
    Reporting group description
    Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group values
    AZD8931 160 mg bd AZD8931 120 mg bd AZD8931 80 mg bd AZD8931 40 mg bd AZD8931 40MG bd + Paclitaxel Placebo + Paclitaxel Total
    Number of subjects
    6 2 6 6 94 96 210
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0
        Adults (18-64 years)
    5 1 6 5 72 84 173
        From 65-84 years
    1 1 0 1 22 12 37
        85 years and over
    0 0 0 0 0 0 0
    Age Continuous | Age for Part A
    Units: Years
        arithmetic mean (standard deviation)
    52.7 ± 11.78 62 ± 16.97 47.2 ± 5.85 54.8 ± 11.07 54.5 ± 11.87 53.1 ± 10.64 -
    Gender, Male/Female
    Units: Participants
        Female
    5 2 5 4 94 96 206
        Male
    1 0 1 2 0 0 4
    Age, Customized
    Units: Subjects
        18-<50 years
    3 0 3 2 34 38 80
        50-<=65 years
    2 1 3 3 38 46 93
        >65-<75 years
    1 1 0 1 18 11 32
        >=75 years
    0 0 0 0 4 1 5
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 2 2 4
        Asian
    0 0 0 0 0 1 1
        Black or African American
    0 0 0 0 4 1 5
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0 0 0
        White
    6 2 6 6 75 74 169
        Other
    0 0 0 0 13 18 31
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    6 2 6 6 35 31 86
        Native American
    0 0 0 0 0 0 0
        Native Alaskan / Inuit
    0 0 0 0 0 0 0
        Native Hawaiian / Pacific Islander
    0 0 0 0 0 0 0
        African
    0 0 0 0 0 0 0
        African-American
    0 0 0 0 0 0 0
        African-Caribbean
    0 0 0 0 0 1 1
        Asian (other than Chinese and Japanese)
    0 0 0 0 0 1 1
        Chinese
    0 0 0 0 0 0 0
        Japanese
    0 0 0 0 0 0 0
        Other
    0 0 0 0 47 49 96
        Not Applicable
    0 0 0 0 12 14 26

    End points

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    End points reporting groups
    Reporting group title
    AZD8931 160 mg bd
    Reporting group description
    Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group title
    AZD8931 120 mg bd
    Reporting group description
    Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group title
    AZD8931 80 mg bd
    Reporting group description
    Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group title
    AZD8931 40 mg bd
    Reporting group description
    Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group title
    AZD8931 40MG bd + Paclitaxel
    Reporting group description
    Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Reporting group title
    Placebo + Paclitaxel
    Reporting group description
    Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle

    Primary: Phase I: The number of dose limiting toxicities in AZD8931 in combination with weekly paclitaxel

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    End point title
    Phase I: The number of dose limiting toxicities in AZD8931 in combination with weekly paclitaxel [1] [2]
    End point description
    DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade ≥3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval > 500 msec, two ECGs ≥ 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of ≥20% to below the LLN; CS rash remaining CTCAE grade ≥3 for ≥5 days despite optimal treatment; CTCAE grade ≥3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade ≥3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by ≥7 days. Patients could have more than one DLT.
    End point type
    Primary
    End point timeframe
    Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There is no analysis for the DLT data as, as per the protocol, this data was to be used to determine the maximum tolerated dose and no analysis was documented in the protocol.
    [2] - 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: As per the study protocol, the assessment of maximum tolerated dose was only to be performed for part A of the study, and so DLTs were only determined in part A. As such, data is only reported for the Part B treatment groups.
    End point values
    AZD8931 160 mg bd AZD8931 120 mg bd AZD8931 80 mg bd AZD8931 40 mg bd
    Number of subjects analysed
    6
    2
    6
    6
    Units: Number of Dose Limiting Toxicities
        Total
    2
    1
    2
    0
        Eye disorders: Keratitis
    1
    0
    0
    0
        Eye disorders: Photophobia
    1
    0
    0
    0
        Gastrointestinal disorders: Diarrhoea
    1
    1
    0
    0
        Gastrointestinal disorders: Oesophagitis
    0
    0
    1
    0
        Infections and infestations: Rash pustular
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Phase II: Progression-free-survival (PFS) were analyzed in patients treated with AZD8931 in combination with weekly paclitaxel versus weekly paclitaxel alone

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    End point title
    Phase II: Progression-free-survival (PFS) were analyzed in patients treated with AZD8931 in combination with weekly paclitaxel versus weekly paclitaxel alone [3]
    End point description
    Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression)
    End point type
    Primary
    End point timeframe
    Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per the study protocol, the analysis of ORR was only to be performed for part B of the study. As such, data is only reported for the Part B treatment groups.
    End point values
    AZD8931 40MG bd + Paclitaxel Placebo + Paclitaxel
    Number of subjects analysed
    94
    96
    Units: Months
        median (inter-quartile range (Q1-Q3))
    8.7 (4.2 to 12.9)
    9.1 (3.4 to 14.8)
    Statistical analysis title
    PFS in AZD8931+ paclitaxel v paclitaxel alone
    Statistical analysis description
    Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.
    Comparison groups
    AZD8931 40MG bd + Paclitaxel v Placebo + Paclitaxel
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.679 [4]
    Method
    Cox Proportional Hazard model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    1.52
    Notes
    [4] - Statistical significance threshold at this analysis was 5%

    Secondary: Phase II: Objective tumour response rate (ORR) was compared in patients treated with AZD8931 in combination with weekly paclitaxel versus weekly paclitaxel alone

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    End point title
    Phase II: Objective tumour response rate (ORR) was compared in patients treated with AZD8931 in combination with weekly paclitaxel versus weekly paclitaxel alone [5]
    End point description
    The number of subjects with at least one visit response of CR or PR (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline))
    End point type
    Secondary
    End point timeframe
    Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012
    Notes
    [5] - 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: As per the study protocol, the analysis of ORR was only to be performed for part B of the study. As such, data is only reported for the Part B treatment groups.
    End point values
    AZD8931 40MG bd + Paclitaxel Placebo + Paclitaxel
    Number of subjects analysed
    88
    85
    Units: Participants
        Total
    52
    35
        Complete Response
    11
    6
        Partial Response
    41
    29
    Statistical analysis title
    ORR in AZD8931+ paclitaxel v paclitaxel alone
    Statistical analysis description
    Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.
    Comparison groups
    AZD8931 40MG bd + Paclitaxel v Placebo + Paclitaxel
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.026 [6]
    Method
    Logistic Regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.09
         upper limit
    3.75
    Notes
    [6] - Statistical significance threshold at this analysis was 5%

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
    Adverse event reporting additional description
    In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    1415
    Reporting groups
    Reporting group title
    AZD8931 40 mg bd
    Reporting group description
    NA

    Reporting group title
    AZD8931 80 mg bd
    Reporting group description
    NA

    Reporting group title
    AZD8931 120 mg bd
    Reporting group description
    NA

    Reporting group title
    AZD8931 160 mg bd
    Reporting group description
    NA

    Reporting group title
    AZD8931 40MG bd + Paclitaxel
    Reporting group description
    NA

    Reporting group title
    Placebo + Paclitaxel
    Reporting group description
    NA

    Serious adverse events
    AZD8931 40 mg bd AZD8931 80 mg bd AZD8931 120 mg bd AZD8931 160 mg bd AZD8931 40MG bd + Paclitaxel Placebo + Paclitaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    3 / 6 (50.00%)
    24 / 94 (25.53%)
    14 / 95 (14.74%)
         number of deaths (all causes)
    0
    0
    1
    2
    28
    24
         number of deaths resulting from adverse events
    Vascular disorders
    HAEMATOMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    THROMBOSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CATHETER SITE INFLAMMATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    BREAST FIBROSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    HUMERUS FRACTURE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PUBIS FRACTURE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    BODY TEMPERATURE INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    EJECTION FRACTION DECREASED
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    CARDIAC FAILURE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SUPRAVENTRICULAR TACHYCARDIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FEBRILE NEUTROPENIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    2 / 95 (2.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NEUTROPENIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PANCYTOPENIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    HYDROTHORAX
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    DYSPNOEA
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    4 / 94 (4.26%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONITIS
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMOTHORAX
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    PULMONARY OEDEMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    CONVULSION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VERTEBROBASILAR INSUFFICIENCY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VOCAL CORD PARALYSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    KERATITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NAUSEA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OESOPHAGITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VOMITING
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    RENAL FAILURE ACUTE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Skin and subcutaneous tissue disorders
    PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DERMATITIS ACNEIFORM
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SKIN NECROSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SKIN ULCER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    MYOPATHY
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    HYPOGLYCAEMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPOKALAEMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPONATRAEMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    PLEURAL INFECTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CATHETER SITE INFECTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DEVICE RELATED INFECTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DEVICE RELATED SEPSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    PNEUMONIA PRIMARY ATYPICAL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PSEUDOMONAS INFECTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PYELONEPHRITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RASH PUSTULAR
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SEPTIC SHOCK
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    AZD8931 40 mg bd AZD8931 80 mg bd AZD8931 120 mg bd AZD8931 160 mg bd AZD8931 40MG bd + Paclitaxel Placebo + Paclitaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    2 / 2 (100.00%)
    6 / 6 (100.00%)
    93 / 94 (98.94%)
    94 / 95 (98.95%)
    Vascular disorders
    FLUSHING
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    11
    5
    HAEMATOMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    HAEMORRHAGE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    HOT FLUSH
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    2
    3
    HYPERAEMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    HYPERTENSION
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    7 / 94 (7.45%)
    3 / 95 (3.16%)
         occurrences all number
    0
    2
    0
    0
    24
    4
    HYPOTENSION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    LYMPHOEDEMA
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    3 / 94 (3.19%)
    6 / 95 (6.32%)
         occurrences all number
    1
    0
    0
    1
    3
    6
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    PHLEBITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    VASCULITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    VARICOSE VEIN
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BREAST CANCER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    UTERINE LEIOMYOMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Immune system disorders
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    5 / 94 (5.32%)
    3 / 95 (3.16%)
         occurrences all number
    1
    0
    0
    0
    5
    4
    HYPERSENSITIVITY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    5 / 6 (83.33%)
    6 / 6 (100.00%)
    2 / 2 (100.00%)
    5 / 6 (83.33%)
    25 / 94 (26.60%)
    12 / 95 (12.63%)
         occurrences all number
    8
    11
    2
    7
    30
    16
    AXILLARY PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    CATHETER SITE ERYTHEMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    CATHETER SITE HAEMATOMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    CATHETER SITE INFLAMMATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    CATHETER SITE PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    CHEST DISCOMFORT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    CHEST PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    CHILLS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    5 / 94 (5.32%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    5
    0
    DISCOMFORT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    FACE OEDEMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    FATIGUE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    25 / 94 (26.60%)
    25 / 95 (26.32%)
         occurrences all number
    0
    0
    0
    0
    40
    29
    FEELING COLD
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    GAIT DISTURBANCE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 94 (1.06%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    INFUSION SITE DISCOMFORT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    IRRITABILITY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    MALAISE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    MUCOSAL DRYNESS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    MUCOSAL INFLAMMATION
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    21 / 94 (22.34%)
    9 / 95 (9.47%)
         occurrences all number
    0
    1
    0
    0
    35
    9
    NODULE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    5 / 94 (5.32%)
    0 / 95 (0.00%)
         occurrences all number
    1
    0
    0
    0
    5
    0
    OEDEMA
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    4 / 94 (4.26%)
    3 / 95 (3.16%)
         occurrences all number
    0
    1
    0
    0
    4
    3
    OEDEMA PERIPHERAL
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    10 / 94 (10.64%)
    11 / 95 (11.58%)
         occurrences all number
    2
    0
    0
    0
    13
    18
    PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    9 / 94 (9.57%)
    4 / 95 (4.21%)
         occurrences all number
    0
    0
    0
    0
    16
    17
    PYREXIA
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    7 / 94 (7.45%)
    11 / 95 (11.58%)
         occurrences all number
    1
    2
    0
    0
    9
    11
    SPINAL PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    XEROSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    AFFECT LABILITY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    ANXIETY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    6 / 94 (6.38%)
    11 / 95 (11.58%)
         occurrences all number
    0
    0
    0
    0
    6
    13
    APATHY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    BRADYPHRENIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    CONFUSIONAL STATE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    DEPRESSED MOOD
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    4 / 95 (4.21%)
         occurrences all number
    0
    0
    0
    0
    4
    4
    DEPRESSION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    4 / 95 (4.21%)
         occurrences all number
    0
    0
    0
    0
    2
    4
    INSOMNIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    12 / 94 (12.77%)
    14 / 95 (14.74%)
         occurrences all number
    0
    0
    0
    1
    13
    14
    MOOD ALTERED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    NERVOUSNESS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    RESTLESSNESS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    SLEEP DISORDER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    BREAST DISCHARGE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    BREAST ENGORGEMENT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    BREAST HAEMORRHAGE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    BREAST INFLAMMATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    BREAST PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    5
    2
    GENITAL DISCHARGE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    GENITAL RASH
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    VAGINAL INFLAMMATION
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    VULVAL ULCERATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    VULVOVAGINAL BURNING SENSATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    VULVOVAGINAL PRURITUS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Injury, poisoning and procedural complications
    ARTHROPOD BITE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    ARTHROPOD STING
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    CONTUSION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    ESCHAR
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    FALL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    HEAD INJURY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    INFUSION RELATED REACTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    1
    6
    LACERATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    LIGAMENT SPRAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    LIMB INJURY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    POST PROCEDURAL COMPLICATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    PROCEDURAL PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    RECALL PHENOMENON
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    RIB FRACTURE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    SKIN INJURY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    THERMAL BURN
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    TOOTH FRACTURE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    WOUND
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    WOUND DEHISCENCE
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    Investigations
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    BLOOD CHOLESTEROL INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    BLOOD POTASSIUM DECREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    CAPILLARY FRAGILITY TEST
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    ELECTROCARDIOGRAM CHANGE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    ELECTROCARDIOGRAM QT PROLONGED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    4 / 94 (4.26%)
    4 / 95 (4.21%)
         occurrences all number
    0
    0
    0
    0
    6
    5
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    HAEMOGLOBIN DECREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    LIVER FUNCTION TEST ABNORMAL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    PULMONARY PHYSICAL EXAMINATION ABNORMAL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    TRANSAMINASES INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    URINE COLOUR ABNORMAL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    WEIGHT DECREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    8 / 94 (8.51%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    9
    3
    WEIGHT INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    4 / 95 (4.21%)
         occurrences all number
    0
    0
    0
    0
    2
    4
    Cardiac disorders
    ANGINA UNSTABLE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    PALPITATIONS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    PERICARDIAL EFFUSION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    VENTRICULAR EXTRASYSTOLES
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    CARDIAC FAILURE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    LEFT VENTRICULAR DYSFUNCTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    TACHYCARDIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    2
    4
    Respiratory, thoracic and mediastinal disorders
    BRONCHOPNEUMOPATHY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    BRONCHOSPASM
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    COUGH
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
    2 / 6 (33.33%)
    12 / 94 (12.77%)
    19 / 95 (20.00%)
         occurrences all number
    3
    3
    0
    2
    14
    26
    DYSPHONIA
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    2 / 94 (2.13%)
    3 / 95 (3.16%)
         occurrences all number
    1
    0
    0
    1
    2
    3
    DYSPNOEA
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    7 / 94 (7.45%)
    8 / 95 (8.42%)
         occurrences all number
    5
    0
    1
    0
    10
    8
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    EPISTAXIS
         subjects affected / exposed
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    19 / 94 (20.21%)
    11 / 95 (11.58%)
         occurrences all number
    2
    4
    0
    1
    21
    12
    HAEMOPTYSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    HICCUPS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    HYPEROXIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    HYPOXIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    NASAL CONGESTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    NASAL DISCOMFORT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    NASAL DRYNESS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    3 / 94 (3.19%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    NASAL MUCOSAL DISORDER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    NASAL OBSTRUCTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    OBSTRUCTIVE AIRWAYS DISORDER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    OROPHARYNGEAL DISCOMFORT
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    2
    3
    PLEURITIC PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    PNEUMOTHORAX
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    PRODUCTIVE COUGH
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    PULMONARY EMBOLISM
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    PULMONARY OEDEMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    RHINALGIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    SINUS CONGESTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    THROAT IRRITATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    UPPER AIRWAY OBSTRUCTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    WHEEZING
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    RHINORRHOEA
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    1 / 95 (1.05%)
         occurrences all number
    1
    2
    0
    0
    3
    1
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    23 / 94 (24.47%)
    10 / 95 (10.53%)
         occurrences all number
    0
    0
    0
    1
    34
    14
    GRANULOCYTOPENIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    LEUKOPENIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    5 / 94 (5.32%)
    5 / 95 (5.26%)
         occurrences all number
    0
    0
    0
    0
    27
    7
    LYMPH NODE PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    LYMPHADENOPATHY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    NEUTROPENIA
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    14 / 94 (14.89%)
    39 / 95 (41.05%)
         occurrences all number
    0
    1
    0
    0
    42
    86
    Nervous system disorders
    AGEUSIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    AMNESIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    ANOSMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    APHASIA
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    APHONIA
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    0 / 95 (0.00%)
         occurrences all number
    0
    1
    0
    0
    3
    0
    ATAXIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    COGNITIVE DISORDER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    DIZZINESS
         subjects affected / exposed
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    7 / 94 (7.45%)
    7 / 95 (7.37%)
         occurrences all number
    2
    3
    0
    1
    10
    10
    DYSAESTHESIA
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    DYSARTHRIA
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    DYSGEUSIA
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    9 / 94 (9.57%)
    2 / 95 (2.11%)
         occurrences all number
    0
    1
    0
    1
    13
    2
    FACIAL NEURALGIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    HEADACHE
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    13 / 94 (13.83%)
    16 / 95 (16.84%)
         occurrences all number
    0
    2
    0
    0
    21
    18
    HYPOAESTHESIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    4 / 95 (4.21%)
         occurrences all number
    0
    0
    0
    0
    3
    4
    HYPOGEUSIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    HYPOKINESIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    HYPOSMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    LETHARGY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    6 / 94 (6.38%)
    4 / 95 (4.21%)
         occurrences all number
    0
    0
    0
    0
    7
    4
    MIGRAINE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    MIGRAINE WITH AURA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    MOTOR DYSFUNCTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    NEURALGIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    6
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    2 / 6 (33.33%)
    28 / 94 (29.79%)
    25 / 95 (26.32%)
         occurrences all number
    0
    0
    0
    3
    34
    27
    PARAESTHESIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    13 / 94 (13.83%)
    19 / 95 (20.00%)
         occurrences all number
    0
    0
    0
    0
    18
    22
    PERIPHERAL SENSORY NEUROPATHY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    11 / 94 (11.70%)
    11 / 95 (11.58%)
         occurrences all number
    0
    0
    0
    0
    13
    13
    POLYNEUROPATHY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    3
    1
    PRESYNCOPE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    RESTLESS LEGS SYNDROME
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    SCIATICA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    TREMOR
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    DISTURBANCE IN ATTENTION
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    NEUROTOXICITY
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 6 (66.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    5 / 94 (5.32%)
    10 / 95 (10.53%)
         occurrences all number
    0
    4
    0
    0
    8
    19
    Eye disorders
    ASTHENOPIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    BLEPHARITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    CATARACT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    CONJUNCTIVAL DISORDER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    CONJUNCTIVITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 6 (50.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    7 / 94 (7.45%)
    5 / 95 (5.26%)
         occurrences all number
    0
    3
    0
    1
    7
    5
    DRY EYE
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    3 / 6 (50.00%)
    8 / 94 (8.51%)
    3 / 95 (3.16%)
         occurrences all number
    0
    1
    0
    4
    8
    3
    ERYTHEMA OF EYELID
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    EXOPHTHALMOS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    EXTRAOCULAR MUSCLE PARESIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    EYE DISORDER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    EYE HAEMORRHAGE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    EYE IRRITATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    4 / 94 (4.26%)
    5 / 95 (5.26%)
         occurrences all number
    0
    0
    0
    0
    4
    5
    EYE PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    EYE PRURITUS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    2 / 94 (2.13%)
    3 / 95 (3.16%)
         occurrences all number
    0
    1
    0
    1
    2
    3
    EYELID OEDEMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    KERATITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    0
    1
    0
    1
    1
    1
    LACRIMATION INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    1 / 95 (1.05%)
         occurrences all number
    0
    1
    0
    0
    6
    1
    MACULAR DEGENERATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    MYOPIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    OCULAR HYPERAEMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    3 / 95 (3.16%)
         occurrences all number
    0
    3
    0
    0
    3
    3
    OCULAR TOXICITY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    PHOTOPHOBIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    2 / 94 (2.13%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    2
    2
    2
    PUNCTATE KERATITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    SCLERAL HYPERAEMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    VISUAL ACUITY REDUCED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    VISUAL IMPAIRMENT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    3
    2
    XEROPHTHALMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    VISION BLURRED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    4 / 94 (4.26%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    4
    3
    Ear and labyrinth disorders
    DEAFNESS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    EAR DISCOMFORT
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    EAR PAIN
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    VERTIGO
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    VERTIGO POSITIONAL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    TINNITUS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    ABDOMINAL DISTENSION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    8 / 94 (8.51%)
    12 / 95 (12.63%)
         occurrences all number
    0
    1
    0
    1
    9
    17
    ABDOMINAL PAIN LOWER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 6 (66.67%)
    0 / 2 (0.00%)
    2 / 6 (33.33%)
    15 / 94 (15.96%)
    7 / 95 (7.37%)
         occurrences all number
    0
    6
    0
    2
    20
    11
    ANAL FISSURE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    3
    1
    ANAL INFLAMMATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    ANAL PRURITUS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    APHTHOUS STOMATITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    4 / 94 (4.26%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    4
    1
    CHAPPED LIPS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    CHEILITIS
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    5 / 94 (5.32%)
    0 / 95 (0.00%)
         occurrences all number
    2
    1
    0
    1
    8
    0
    CONSTIPATION
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    2 / 6 (33.33%)
    19 / 94 (20.21%)
    23 / 95 (24.21%)
         occurrences all number
    1
    0
    0
    2
    25
    29
    DENTAL CARIES
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    DIARRHOEA
         subjects affected / exposed
    5 / 6 (83.33%)
    6 / 6 (100.00%)
    2 / 2 (100.00%)
    5 / 6 (83.33%)
    78 / 94 (82.98%)
    33 / 95 (34.74%)
         occurrences all number
    12
    25
    3
    15
    247
    65
    DRY MOUTH
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    2 / 6 (33.33%)
    5 / 94 (5.32%)
    1 / 95 (1.05%)
         occurrences all number
    1
    2
    0
    2
    5
    1
    DYSPEPSIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    16 / 94 (17.02%)
    9 / 95 (9.47%)
         occurrences all number
    0
    0
    0
    0
    19
    9
    DYSPHAGIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    3
    2
    EPIGASTRIC DISCOMFORT
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    GASTRIC DISORDER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    GASTRIC ULCER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    GASTRITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    5 / 94 (5.32%)
    5 / 95 (5.26%)
         occurrences all number
    0
    0
    0
    0
    5
    5
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    GINGIVAL BLEEDING
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    GINGIVITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    GLOSSITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    GLOSSODYNIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    HAEMORRHOIDS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    5 / 94 (5.32%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    5
    4
    HYPOAESTHESIA ORAL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    INTESTINAL POLYP
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    LIP DRY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    LIP PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    MUCOUS STOOLS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    NAUSEA
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    1 / 2 (50.00%)
    3 / 6 (50.00%)
    39 / 94 (41.49%)
    30 / 95 (31.58%)
         occurrences all number
    1
    3
    1
    5
    69
    39
    ODYNOPHAGIA
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    1 / 95 (1.05%)
         occurrences all number
    1
    0
    1
    0
    4
    1
    OESOPHAGEAL PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    OESOPHAGITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    ORAL DISCOMFORT
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    ORAL DYSAESTHESIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    ORAL MUCOSAL BLISTERING
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    ORAL PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    ORAL TOXICITY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    PERIANAL ERYTHEMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    PROCTALGIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    RECTAL FISSURE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    STOMATITIS
         subjects affected / exposed
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    1 / 2 (50.00%)
    1 / 6 (16.67%)
    20 / 94 (21.28%)
    3 / 95 (3.16%)
         occurrences all number
    2
    7
    1
    1
    26
    3
    TOOTHACHE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    5 / 95 (5.26%)
         occurrences all number
    0
    0
    0
    0
    3
    8
    VOMITING
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    2 / 6 (33.33%)
    24 / 94 (25.53%)
    14 / 95 (14.74%)
         occurrences all number
    1
    2
    1
    3
    43
    27
    Renal and urinary disorders
    BLADDER PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    CYSTITIS HAEMORRHAGIC
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    DYSURIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    10 / 94 (10.64%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    13
    4
    HAEMATURIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    POLLAKIURIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    PROTEINURIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    PYURIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    RENAL FAILURE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    RENAL FAILURE ACUTE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    URINARY INCONTINENCE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    INCONTINENCE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    LEUKOCYTURIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    5 / 94 (5.32%)
    4 / 95 (4.21%)
         occurrences all number
    0
    0
    0
    0
    6
    5
    Hepatobiliary disorders
    GALLBLADDER PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    HEPATOTOXICITY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    ALOPECIA
         subjects affected / exposed
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    45 / 94 (47.87%)
    48 / 95 (50.53%)
         occurrences all number
    2
    3
    0
    0
    45
    49
    DERMAL CYST
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    DERMATITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    DERMATITIS ACNEIFORM
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    21 / 94 (22.34%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    40
    2
    DERMATITIS ALLERGIC
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    DRUG ERUPTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    ECZEMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    ERYTHEMA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    7 / 94 (7.45%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    9
    2
    EXFOLIATIVE RASH
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    HEAT RASH
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    INGROWING NAIL
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    INTERTRIGO
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    MADAROSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    NAIL DISCOLOURATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    4 / 94 (4.26%)
    2 / 95 (2.11%)
         occurrences all number
    0
    0
    0
    0
    4
    2
    NAIL DISORDER
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    7 / 94 (7.45%)
    8 / 95 (8.42%)
         occurrences all number
    1
    4
    0
    0
    7
    8
    NAIL DYSTROPHY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    3 / 95 (3.16%)
         occurrences all number
    0
    0
    0
    0
    3
    4
    NAIL PIGMENTATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    ONYCHOCLASIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    ONYCHOLYSIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    4 / 94 (4.26%)
    5 / 95 (5.26%)
         occurrences all number
    0
    0
    0
    0
    4
    5
    ONYCHOMADESIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    4 / 94 (4.26%)
    0 / 95 (0.00%)
         occurrences all number
    0
    2
    0
    0
    5
    0
    PHOTOSENSITIVITY REACTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    PRURITUS
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    18 / 94 (19.15%)
    6 / 95 (6.32%)
         occurrences all number
    1
    4
    0
    0
    19
    6
    PRURITUS GENERALISED
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    PURPURA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    RASH
         subjects affected / exposed
    3 / 6 (50.00%)
    5 / 6 (83.33%)
    1 / 2 (50.00%)
    4 / 6 (66.67%)
    59 / 94 (62.77%)
    20 / 95 (21.05%)
         occurrences all number
    5
    19
    1
    15
    136
    26
    RASH ERYTHEMATOUS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    RASH GENERALISED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    RASH MACULAR
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    RASH MACULO-PAPULAR
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    4 / 94 (4.26%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    RASH PAPULAR
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    RASH PRURITIC
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    SKIN CHAPPED
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    SKIN DISORDER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    SKIN EXFOLIATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    SKIN FISSURES
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    1 / 6 (16.67%)
    7 / 94 (7.45%)
    1 / 95 (1.05%)
         occurrences all number
    0
    1
    0
    1
    7
    1
    SKIN HYPERPIGMENTATION
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    1 / 95 (1.05%)
         occurrences all number
    1
    0
    0
    0
    2
    1
    SKIN IRRITATION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    SKIN LESION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    SKIN PLAQUE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    1 / 94 (1.06%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    SKIN REACTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    SKIN STRIAE
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    SKIN TOXICITY
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    3 / 94 (3.19%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    SKIN ULCER
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    SWELLING FACE
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 94 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    TELANGIECTASIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    2 / 94 (2.13%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    0
    0