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    Clinical Trial Results:
    Phase III, multicentre, open-label, prospective randomised trial comparing Imatinib alone at 400mg versus 800mg daily versus Imatinib 400mg daily plus PEG Interferon-alpha with newly diagnosed chronic myeloid leukaemia

    Summary
    EudraCT number
    2004-001622-24
    Trial protocol
    IE  
    Global end of trial date
    15 Jan 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Sep 2016
    First version publication date
    08 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Spirit Version 16
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Newcastle upon Tyne Hospitals NHS Trust
    Sponsor organisation address
    Freeman Hospital, Freeman Road, Newcastle upon Tyne, United Kingdom, NE7 7DN
    Public contact
    Spirit Trials Secretary, Spirit Trials Office, 0044 0191 282 0904, enu-tr.spirittrials@nhs.net
    Scientific contact
    Stephen O'Brien, Newcastle Clinical Trials Unit, 0044 0191 282 0904, stephen.o'brien@ncl.ac.uk
    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
    10 Feb 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine overall survival at 5 years
    Protection of trial subjects
    No specific protection in addition to standard care offered to chronic myeloid leukaemia patients
    Background therapy
    -
    Evidence for comparator
    The rationale for combining imatinib with interferon alpha is based on pre-clinical data that demonstrates additive to synergistic anti-proliferative activity of these agents against leukaemic cells in vitro. Clinical studies have shown that the agents, when given in combination, produce higher rates of cytogenetic responses despite using low doses of imatinib. The rationale for using a higher dose of imatinib comes from early studies in newly diagnosed CML patients in chronic phase where a higher cytogenetic response was seen in the higher dose (800mg/day) group than the standard dose (400mg/day) group, 74% versus 59% respectively.
    Actual start date of recruitment
    03 Jun 2005
    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
    United Kingdom: 259
    Worldwide total number of subjects
    259
    EEA total number of subjects
    259
    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)
    208
    From 65 to 84 years
    51
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment opened in June 2005 and closed on 1st February 2009. During that period 259 patients were recruited at 66 sites in the UK.

    Pre-assignment
    Screening details
    Patients only entered screening if they had newly diagnosed chronic myeloid leukaemia in chronic phase. Patients could not be taking any drug therapy for their leukaemia other than hydroxycarbamide on analgrelide and have not undergone bone marrow transplantation. All screening assessments had to be carried out within 14 days of randomisation.

    Period 1
    Period 1 title
    On Treatment Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Imatinib 400mg
    Arm description
    Imatinib 400mg daily
    Arm type
    Active comparator

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    Other name
    Glivec
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Take one 400mg tablet once daily

    Arm title
    Imatinib 800mg
    Arm description
    Imatinib 800mg daily
    Arm type
    Experimental

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    Other name
    Glivec
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Take one 400mg tablet twice daily

    Arm title
    Imatinib 400mg + INF
    Arm description
    Pegylated interferon-alpha and imatinib
    Arm type
    Experimental

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    Other name
    Glivec
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Take one 400mg tablet once daily

    Investigational medicinal product name
    pegylated interferon-alpha
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Starting with dose of 90 micrograms of Pegasys to be given once a week every 4 weeks for 3 weeks, followed by once a week every 2 weeks for a further 4 weeks then once a week every week for 6 weeks then dose increased to 180 micrograms once every week for rest of study period.

    Number of subjects in period 1
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF
    Started
    99
    96
    64
    Start Of Treatment
    98
    96
    64
    Treatment Discontinuation
    98
    96
    64
    Completed
    52
    39
    12
    Not completed
    47
    57
    52
         Adverse event, serious fatal
    4
    1
    2
         Consent withdrawn by subject
    1
    4
    3
         Adverse event, non-fatal
    7
    26
    26
         Other Reasons
    4
    10
    4
         Lost to follow-up
    1
    -
    -
         Lack of efficacy
    28
    16
    14
         Protocol deviation
    2
    -
    3
    Period 2
    Period 2 title
    Off Treatment Period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Imatinib 400mg
    Arm description
    Imatinib 400mg daily
    Arm type
    Active comparator

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    Other name
    Glivec
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Take one 400mg tablet once daily

    Arm title
    Imatinib 800mg
    Arm description
    Imatinib 800mg daily
    Arm type
    Experimental

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    Other name
    Glivec
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Take one 400mg tablet twice daily

    Arm title
    Imatinib 400mg + INF
    Arm description
    Pegylated interferon-alpha and imatinib
    Arm type
    Experimental

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    Other name
    Glivec
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Take one 400mg tablet once daily

    Investigational medicinal product name
    pegylated interferon-alpha
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Starting with dose of 90 micrograms of Pegasys to be given once a week every 4 weeks for 3 weeks, followed by once a week every 2 weeks for a further 4 weeks then once a week every week for 6 weeks then dose increased to 180 micrograms once every week for rest of study period.

    Number of subjects in period 2
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF
    Started
    52
    39
    12
    Completed
    52
    39
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Imatinib 400mg
    Reporting group description
    Imatinib 400mg daily

    Reporting group title
    Imatinib 800mg
    Reporting group description
    Imatinib 800mg daily

    Reporting group title
    Imatinib 400mg + INF
    Reporting group description
    Pegylated interferon-alpha and imatinib

    Reporting group values
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF Total
    Number of subjects
    99 96 64 259
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    78 80 50 208
        From 65-84 years
    21 16 14 51
        85 years and over
    0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.414 ± 13.771 52.073 ± 13.406 53.75 ± 13.406 -
    Gender categorical
    Units: Subjects
        Female
    39 36 22 97
        Male
    60 60 42 162
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    77.426 ± 16.686 81.867 ± 19.63 77.389 ± 15.698 -
    Height
    Units: meters
        arithmetic mean (standard deviation)
    1.699 ± 0.089 1.713 ± 0.094 1.707 ± 0.109 -
    BMI
    Body Mass Index
    Units: Kg/(m^2)
        arithmetic mean (standard deviation)
    26.639 ± 4.987 27.739 ± 6.708 26.3 ± 4.003 -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS is defined as all randomised patients who received study medication at least once. Patients will be analysed according to the treatment group to which they were randomised, rather than by the actual treatment they were administered. The FAS is the primary population of interest for all efficacy analyses.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All patients who are randomised into the study and who received study medication at least once will be considered evaluable for the Safety Set. This is the same definition as the FAS. However, in the event that a patient receives study medication other than that to which they have been randomised, analyses based on the Safety Set will be performed using the actual treatment group that was administered and so will be different to the FAS. All safety tables will be based on the Safety Set.

    Subject analysis sets values
    Full Analysis Set Safety Set
    Number of subjects
    258
    258
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    207
    207
        From 65-84 years
    51
    51
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.659 ± 13.155
    52.659 ± 13.155
    Gender categorical
    Units: Subjects
        Female
    96
    96
        Male
    162
    162
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    78.579 ± 18.996
    78.579 ± 18.996
    Height
    Units: meters
        arithmetic mean (standard deviation)
    1.706 ± 0.096
    1.706 ± 0.096
    BMI
    Body Mass Index
    Units: Kg/(m^2)
        arithmetic mean (standard deviation)
    26.994 ± 5.558
    26.994 ± 5.558

    End points

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    End points reporting groups
    Reporting group title
    Imatinib 400mg
    Reporting group description
    Imatinib 400mg daily

    Reporting group title
    Imatinib 800mg
    Reporting group description
    Imatinib 800mg daily

    Reporting group title
    Imatinib 400mg + INF
    Reporting group description
    Pegylated interferon-alpha and imatinib
    Reporting group title
    Imatinib 400mg
    Reporting group description
    Imatinib 400mg daily

    Reporting group title
    Imatinib 800mg
    Reporting group description
    Imatinib 800mg daily

    Reporting group title
    Imatinib 400mg + INF
    Reporting group description
    Pegylated interferon-alpha and imatinib

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS is defined as all randomised patients who received study medication at least once. Patients will be analysed according to the treatment group to which they were randomised, rather than by the actual treatment they were administered. The FAS is the primary population of interest for all efficacy analyses.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All patients who are randomised into the study and who received study medication at least once will be considered evaluable for the Safety Set. This is the same definition as the FAS. However, in the event that a patient receives study medication other than that to which they have been randomised, analyses based on the Safety Set will be performed using the actual treatment group that was administered and so will be different to the FAS. All safety tables will be based on the Safety Set.

    Primary: Overall Survival at 5 Years

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    End point title
    Overall Survival at 5 Years
    End point description
    To compare overall survival in the three arms at 5 years
    End point type
    Primary
    End point timeframe
    5 years
    End point values
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF
    Number of subjects analysed
    98 [1]
    96 [2]
    64 [3]
    Units: Patients Alive at 5 Years
        Patients Alive
    27
    19
    8
        Patients Died
    71
    77
    56
    Attachments
    Kaplan-Meier plot
    Notes
    [1] - Full Analysis Set
    [2] - Full Analysis Set
    [3] - Full Analysis Set
    Statistical analysis title
    Kaplan-Meier
    Statistical analysis description
    The proportion of patients surviving to 5 years will be summarised by treatment group for the FAS. A Kaplan-Meier Plot will be produced using the following method of censoring: Patients discontinuing study medication for any reason other than death will be censored at the time of discontinuation from study drug. For Overall Survival, irrespective of any further follow-up/last contact information.
    Comparison groups
    Imatinib 800mg v Imatinib 400mg v Imatinib 400mg + INF
    Number of subjects included in analysis
    258
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0246 [4]
    Method
    Logrank
    Confidence interval
    Notes
    [4] - The Log-Rank test was planned in the protocol, however due to the lack of sample size, the study is underpowered, and therefore this hypotesis test will not be performed.

    Secondary: Molecular Response

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    End point title
    Molecular Response
    End point description
    To compare the level of molecular response (BCR-ABL/ABL ratio by real time PCR after one year of study therapy in each of the treatment arms.
    End point type
    Secondary
    End point timeframe
    After 1 year of therapy (Visit 7).
    End point values
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF
    Number of subjects analysed
    98 [5]
    96 [6]
    64 [7]
    Units: Patients with Molecular Response
        Molecular Response 3 (MR3) - PCR <0.1%
    23
    33
    18
        Molecular Response 4 (MR4) - PCR <0.01%
    7
    9
    10
        Molecular Response 4.5 (MR4.5) - PCR <0.0032%
    3
    3
    5
        No Molecular Response
    65
    51
    31
    Notes
    [5] - Full Analysis Set
    [6] - Full Analysis Set
    [7] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Time to Progression

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    End point title
    Time to Progression
    End point description
    To compare time to progression in the three arms of the study according to progression definitions in protocol.
    End point type
    Secondary
    End point timeframe
    From start of therapy to protocol definition of progression.
    End point values
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF
    Number of subjects analysed
    96 [8]
    93 [9]
    64 [10]
    Units: Months
        arithmetic mean (standard deviation)
    40.4 ± 23.94
    34.38 ± 23.69
    22.22 ± 21.77
    Notes
    [8] - Selection of Patients with Available data for the Endpoint from Full Analysis Set
    [9] - Selection of Patients with Available data for the Endpoint from Full Analysis Set
    [10] - Selection of Patients with Available data for the Endpoint from Full Analysis Set
    No statistical analyses for this end point

    Secondary: Time to Treatment Failure

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    End point title
    Time to Treatment Failure
    End point description
    To compare time to treatment failure in the three arms of the study.
    End point type
    Secondary
    End point timeframe
    From start of treatment to documented protocol defined treatment failure.
    End point values
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF
    Number of subjects analysed
    98 [11]
    96 [12]
    64 [13]
    Units: Months
        arithmetic mean (standard deviation)
    44.57 ± 27.37
    50.98 ± 24.41
    47.36 ± 25.58
    Notes
    [11] - Full Analysis Set
    [12] - Full Analysis Set
    [13] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Rate of Cytogenetic Response

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    End point title
    Rate of Cytogenetic Response
    End point description
    To compare rate of cytogenetic responses (major and complete) at one year and the cumulative incidence of such responses with each of the regimens.
    End point type
    Secondary
    End point timeframe
    At 1 year after study treatment started (Visit 7).
    End point values
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF
    Number of subjects analysed
    98 [14]
    96 [15]
    64 [16]
    Units: Patients
        No cytogenetic response
    35
    22
    17
        Major cytogenetic response
    36
    40
    26
        Complete cytogenetic response
    27
    34
    21
    Notes
    [14] - Full Analysis Set
    [15] - Full Analysis Set
    [16] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Complete Haematological Response Rate

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    End point title
    Complete Haematological Response Rate
    End point description
    To compare the rates of complete haematological response in patients treated with all regimens.
    End point type
    Secondary
    End point timeframe
    Whole 5 year study period
    End point values
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF
    Number of subjects analysed
    98 [17]
    96 [18]
    64 [19]
    Units: Patients
        Hematological Responders
    93
    88
    61
        Hematological Non-Responders
    5
    8
    3
    Notes
    [17] - Full Analysis Set Patients
    [18] - Full Analysis Set Patients
    [19] - Full Analysis Set Patients
    No statistical analyses for this end point

    Secondary: Tolerability

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    End point title
    Tolerability
    End point description
    To compare tolerability of these regimens.
    End point type
    Secondary
    End point timeframe
    Whole 5 year study period.
    End point values
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF
    Number of subjects analysed
    98 [20]
    96 [21]
    64 [22]
    Units: Patients with AE Related to Study Drug
        Patients who experienced AEs Related to Study Drug
    76
    89
    55
        Patient without AEs Related to Study Drug
    22
    7
    9
    Notes
    [20] - Full Analysis Set
    [21] - Full Analysis Set
    [22] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Quality of Life

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    End point title
    Quality of Life
    End point description
    To assess quality of life on each of the 3 arms.
    End point type
    Secondary
    End point timeframe
    At 1 year from the baseline visit (visit 7).
    End point values
    Imatinib 400mg Imatinib 800mg Imatinib 400mg + INF
    Number of subjects analysed
    98 [23]
    96 [24]
    64 [25]
    Units: Quality of life Scores
    arithmetic mean (standard deviation)
        FACT-G / Total Score / Baseline
    83.96 ± 15.57
    82.13 ± 16.99
    84.13 ± 15.03
        EQ-5D / VAS Score / Baseline
    58 ± 35.58
    54.82 ± 32.94
    69.71 ± 30.69
        FACT-BRM / Total Outcome Index / Baseline
    82.21 ± 18.07
    78.39 ± 19.83
    85.12 ± 18.7
        FACT-G / Total Score / 12 Months
    87.66 ± 16.57
    82.21 ± 19.1
    88.26 ± 11.87
        EQ-5D / VAS Score / 12 Months
    71.34 ± 32.03
    70.5 ± 27.88
    71.25 ± 33.33
        FACT-BRM / Total Outcome Index / 12 Months
    84.92 ± 17.7
    77.91 ± 24.03
    83.31 ± 14.81
    Notes
    [23] - Full Analysis Set
    [24] - Full Analysis Set
    [25] - Full Analysis Set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From date of signed informed consent to 4 weeks post last dose of study drug taken for each subject
    Adverse event reporting additional description
    Adverse events collected by physician, reported by patient or from laboratory tests
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    Reported Term
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Imatinib 400mg
    Reporting group description
    Imatinib 400mg daily

    Reporting group title
    Imatinib 400mg + INF
    Reporting group description
    Pegylated interferon-alpha and imatinib

    Reporting group title
    Imatinib 800mg
    Reporting group description
    Imatinib 800mg daily

    Serious adverse events
    Imatinib 400mg Imatinib 400mg + INF Imatinib 800mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 89 (21.35%)
    10 / 62 (16.13%)
    24 / 107 (22.43%)
         number of deaths (all causes)
    11
    9
    6
         number of deaths resulting from adverse events
    0
    0
    0
    General disorders and administration site conditions
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ACUTE CORONARY SYNDROME
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ACUTE RENAL FALIURE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ADENOCARCINOMA (GI)
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ADENOCARCINOMA OF GI ORIGIN
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ADMITTED TO HOSPITAL WITH SEVERE BONE PAIN ? DUE TO LOW WCC
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    AGITATION DUE TO INFECTED RIGHT TOTAL KNEE REPLACEMENT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ALT RESULT 174-TRIAL DRUGS TEMPORARY STOPPED AWAITING HEPATOLOGY OPINION
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ANAEMIA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ANGIOEDEMA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BLADDER CANCER
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BLAST CRISIS OF CML
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    BLURRED VISION (PERSISTANT MIGRAINE AURA)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BONE PAIN IN PELVIS AND THIGHS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CALF HAEMATOMA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CAMPYLOBACTER GASTROENTERITIS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CARCINOMA OF PROSTATE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CARDIAC ISCHEMIA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CEREBRAL INFARCTION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CHEST INFECTION
         subjects affected / exposed
    2 / 89 (2.25%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CHRONIC RENAL FAILURE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CML TRANSFORMED TO AML
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    CONFUSION DUE TO INFECTED RIGHT TOTAL KNEE REPLACEMENT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COUGH AND MILD FEVER
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CVA/ VENOUS SINUS THROMBOSIS WITH SECONDARY HAEMORRHAGE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DEHYDRATION
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DERANGED LFTS (BORDERLINE GRADE 3 TOXICITY) - ZONE 3 HEPATIC NECROSIS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DIARRHOEA AND VOMITING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DIFFUSE LARGE B-CELL LYMPHOMA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    EPIGASTRIC PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    EXACERBATION OF COPD
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    FAST ATRIAL FIBRILATION AND GRADE 3 PLATELET TOXICITY
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    FATIGUE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    FEVER (WITH NORMAL NEUTROPHILS)
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    GLOSSAL SWELLING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    GRADUAL DECREASE IN FULL BLOOD COUNT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HEADACHES VOMITING, LOOSE BOWELS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HEPATO-TOXICITY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INFECTION
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INFECTIVE EXACERBATION OF FIBROSING ALVEOLITIS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INSOMNIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INTENTIONAL OVERDOSE OF ZOPICLONE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LEFT PNEUMOTHORAX
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    LEFT SIDED STROKE (CVA)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LEFT SUBCONJUNCTIVAL HAEMORRHAGE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LICHEN PLANUS ON TONGUE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LOSS OF CONCIOUSNESS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LOW PHOSPHATES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LOWER LEFT ABDOMINAL PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MENINGOCOCCAL SEPSIS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MENORRAGHIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    NAUSEA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    NAUSEA/SICKNESS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    NEUTROPENIA
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PAIN IN RIGHT LEG FOLLOWING BONE MARROW PROCEDURE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PELVIC AND THIGH BONE PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PNEUMONITIS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PROBABLE ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PROSTATE CANCER
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PT PARTNER MISCARRIED
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RAISED CREATININE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RENAL FAILURE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RESTRICTIVE CARDIOMYOPATHY
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RIGORS / CHILLS - FLUE LIKE SYMPTOMS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SEPTIC EVENT POST TOTAL KNEE REPLACEMENT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SEVERE LOW PRESSUREHEADACHE AS A RESULT OF A CSF LEAK.
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SEVERE MUSCULOSKELETAL PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SEVERE THROAT INFECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SHINGLES
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SHORTNESS OF BREATH (PULMONARY OEDEMA&PNEUMONIA)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SWOLLEN UPPER LIP
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    TOOK AN OVERDOSE OF IMATINIB
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    TRANSFORMATION TO PRE B- CELL ALL.
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VERY LOW MOOD
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VOMITING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VOMITTING
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    WORSENING OF CHRONIC FIBROSING ALVEOLITIS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Imatinib 400mg Imatinib 400mg + INF Imatinib 800mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    88 / 89 (98.88%)
    61 / 62 (98.39%)
    91 / 107 (85.05%)
    General disorders and administration site conditions
    "FRAGILE SKIN"
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    2
    1 WEEK OF FLU LIKE SYMPTOMS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    2 DAYS OF FLU LIKE SYMPTOMS AFTER PEG-INTERFON
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ACUTE VERTIGO, LOUD NOISE, NUMBNESS OF FACE. ATYPICAL MENIERE'S DISEASE.
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ? INFECTED RIGHT KNEE JOINT
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ? PITYRIASIS LICHENOIDES CHRONICA ON LEGS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ABDOMENAL PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ABDOMINAL BLOATING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ABDOMINAL CRAMPS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    2 / 107 (1.87%)
         occurrences all number
    0
    1
    2
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ABDOMINAL OEDEMA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    3 / 62 (4.84%)
    5 / 107 (4.67%)
         occurrences all number
    1
    3
    5
    ABDOMINAL PAIN AND OCCASIONAL CRAMPS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ABDOMINAL PAIN, INCREASED BURPING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ABNORMAL LFT'S
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ABSOULTE NEUTROPHIL COUNT
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ACHES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ACHES AND PAINS IN BOTH THIGHS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ACHES AND PAINS IN JOINTS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ACHES AND PAINS IN LEGS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ACHES IN BODY
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    4
    ACHES IN HIPS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ACHES IN LEGS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    0
    2
    ACHING BONES
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ACHING JOINTS
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    1
    1
    0
    ACHING JOINTS AND FLU SYMPTOMS RELATED TO FLU JAB
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ACHING LEGS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    0
    2
    ACHING LEGS, SHOULDERS AND CALVES
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ACHING MUSCLES
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    1
    ACHING THIGH BONES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ACHING THIGHS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ACHING THIGHS AND GROIN AREAS BILATERALLY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ACID REFLUX
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    ACOUSTIC NUEROMA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    AGGITATION
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    AGITATION/ ANXIETY
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ALLERGIC REACTION (SWOLLEN TONGUE AND NECK)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ALLERGIC REACTION -SWOLLEN TONGUE DURING A MEAL. CAUSE UNKNOWN OF WHICH FOOD ITEM
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ALLERGIC REACTION ? CAUSE AFFECTS TONGUE SWOLLEN AND FLUID COLLECTS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ALLERGIC REACTION AT SITE OF PNEUMOVAX INJECTION (ARM)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ALLERGIC REACTION TO LISINOPRIL
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ALTERED BOWEL FUNCTION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ALTERED SENSE OF TASTE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ALTERED TASTE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ALTERNATING CONSTIPATION AND DIARRHOEA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ALTERNATING DIARRHOEA AND CONSTIPATION
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ALTHRALGIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    AMENORRHOEA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ANAEMIA
         subjects affected / exposed
    7 / 89 (7.87%)
    5 / 62 (8.06%)
    5 / 107 (4.67%)
         occurrences all number
    8
    11
    6
    ANAEMIA HB 10.9G/DL
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ANAL FISSURE
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    1
    ANEMIA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    ANGINA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ANKEL OEDEMA, PUFFY EYES AND FEW CHEST SOUNDS AT RIGHT BASE.
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ANKLE ODEMA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ANKLE OEDEMA
         subjects affected / exposed
    1 / 89 (1.12%)
    4 / 62 (6.45%)
    3 / 107 (2.80%)
         occurrences all number
    1
    5
    3
    ANOREXIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    5 / 107 (4.67%)
         occurrences all number
    0
    0
    5
    ANXIETY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ANXIOUS/PALPITATIONS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    APHTHOUS ULCERS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ARTHRALGIA
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 62 (3.23%)
    3 / 107 (2.80%)
         occurrences all number
    0
    2
    3
    ARTHRALGIA (R LEG)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ARTHRALGIA + MYALGIA
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ARTHRALGIA ONLY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ARTHRALGIA/MYALGIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ARTHROSCOPY LEFT KNEE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ASTENIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ATRIAL FIBRILLATION
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ATTACK OF GOUT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BACK ACHE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    0
    2
    BACK AND HIP PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BACK PAIN
         subjects affected / exposed
    2 / 89 (2.25%)
    2 / 62 (3.23%)
    5 / 107 (4.67%)
         occurrences all number
    2
    2
    5
    BACK PAIN, RSIDED LOWER RIBS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BACKACHE AND NECK PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BI-LATERAL SUBMANDIBULAR LYMPHADENOPATHY
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BILATERAL ANKLE OEDEMA IN BOTH LEGS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BILATERAL ANKLE RASH
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    BILATERAL LOIN PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BILATERAL OEDEMA IN BOTH LEGS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    BILIARY REFLUX
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BLACKOUTS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLEED INTO RIGHT EYE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BLEEDING AROUND EYES
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    BLEEDING FROM BOWELS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLEEDING GIMS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BLEEDING LEFT EYE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BLISTERING RASH ON LEGS WHICH BECAME INFECTED
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLOOD BLISTER IN MOUTH
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLOOD BLISTER ON RIGHT WRIST
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLOOD BLISTERS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLOOD BLISTERS AROUND WRISTS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLOOD SHOT EYES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLOODSHOT LEFT EYE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLOTCHY SKIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLUE TINGE TO TOES AND COLD FEET
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BLURRED VISION
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 62 (1.61%)
    1 / 107 (0.93%)
         occurrences all number
    2
    1
    1
    BLURRED VISION - BILATERAL
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BLURRED VISION LEFT EYE
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    BLURRED VISION.
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BONE AND JOINT PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BONE PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    7 / 107 (6.54%)
         occurrences all number
    1
    0
    7
    BONE PAIN, - BACK, LEGS AND RIBS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BONEY ACHES AND PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    BONEY PROMINENCE RIGHT ELBOW - NEW
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BOWEL FREQUENCY
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BREAST INFECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BREATHLESSNESS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    2
    0
    2
    BRONCHITIS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    BRUISED AROUND INJECTION SITE FROM INSULIN
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    BRUISED LEGS (VERY LARGE BRUISES)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BRUISING
         subjects affected / exposed
    2 / 89 (2.25%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    2
    0
    1
    BRUISING OF BALL OF R FOOT
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BRUISING OVER RIBS ON RIGHT SIDE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BRUSING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    BURNING HEAD AND RED FACE LASTING 4-5HRS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BURNT RIGHT HAND
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    BURSITIS IN RIGHT FOOT
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    BUZZING IN EARS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CALF CRAMPS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    CARDIAC OTHER - MILD DIZZINESS THOUGHT TO BE MILD HYPOTENSION ALTHOUGH BP NOT MEASURED AT CLINIC
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CATARACT REPAIR LEFT EYE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CATTERACT RIGHT EYE FOLLOWING LASER SURGERY FOR RETINA DETACHMENT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CELLULITIS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CENTRAL CHEST PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CENTRAL CHEST PAIN RADIATING TO MID BACK
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CHEST HEAVYNESS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CHEST INFECTION
         subjects affected / exposed
    10 / 89 (11.24%)
    1 / 62 (1.61%)
    6 / 107 (5.61%)
         occurrences all number
    20
    1
    6
    CHEST INFECTION NOS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CHEST INFECTION-DETAILS NOT KNOWN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CHEST PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    CHEST PAIN WITH COLD
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CHEST PAINS AT NIGHT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CHESTY COUGH FROM POST NASAL DRIP
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    CHICKEN POX
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CHILLS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CHRAMP
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CIRCUMORBITAL OEDEMA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    COGNATIVE IMPAIRMENT
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    COLD
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    2
    COLD - RUNNY NOSE AND SORE THROAT
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    COLD AND FLU SYMPTOMS
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    1
    1
    0
    COLD AND FLU SYMPTOMS RELATED TO INTERFERON INJECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    COLD AND UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    COLD FINGERS AND TOES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    COLD INTOLERANCE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    COLD SORE
         subjects affected / exposed
    1 / 89 (1.12%)
    2 / 62 (3.23%)
    1 / 107 (0.93%)
         occurrences all number
    1
    2
    1
    COLD SORE ON LOWER LIP
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    COLD SORE UPPER LIP
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    COLD SORES TO NOSE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    COLD SWEATS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    COLD SYMPTOMS
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 62 (3.23%)
    0 / 107 (0.00%)
         occurrences all number
    0
    3
    0
    COLD VIRUS WITH SINUS DISCHARGE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    COMMON COLD VIRUS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    COMPLAINS OF A REDUCED APPETITE SINCE COMMENCING GLIVEC
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CONJUCTIVITIS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CONJUNCTIVAL INFECTION (RIGHT EYE)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CONJUNCTIVITIS
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 62 (3.23%)
    2 / 107 (1.87%)
         occurrences all number
    0
    2
    2
    CONSTIPATION
         subjects affected / exposed
    2 / 89 (2.25%)
    1 / 62 (1.61%)
    5 / 107 (4.67%)
         occurrences all number
    2
    1
    5
    CONTINUAL UPSET STOMACH
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CORYZAL SYMPTOMS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    COUGH
         subjects affected / exposed
    4 / 89 (4.49%)
    3 / 62 (4.84%)
    2 / 107 (1.87%)
         occurrences all number
    4
    3
    2
    COUGH AND SORE THROAT
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    COUGH AT NIGHT
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    COUGH WITH SPUTUM
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    COUGH/VIRAL INFECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    COVERED IN RASH:HOT AND RED ALL OVER
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    CRAMP
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CRAMP IN HANDS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    0
    2
    CRAMPS
         subjects affected / exposed
    1 / 89 (1.12%)
    4 / 62 (6.45%)
    5 / 107 (4.67%)
         occurrences all number
    1
    4
    5
    CRAMPS HANDS AND LEGS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CRAMPS IN BOTH HANDS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CRAMPS IN BOTH LOWER LEG AREAS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CRAMPS IN CALVES
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CRAMPS IN FEET
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CRAMPS IN FINGERS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CRAMPS IN LEG AND ABDOMEN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CRAMPS IN LEGS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CRAMPS INTERMITTENTLY IN FINGERS AND FEET
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CRAMPS ON CHEST WALL
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    CRAMPS TO KNEE AT NIGHT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CRAMPS, NOT SPECIFIED WHERE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CRAMPS-NOT SPECIFIED
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    CRAMPY ABDOMINAL PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CRAMPY PAIN IN LEGS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    CROHN'S DISEASE
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    CROHNS FLARE UP
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CUT OVER LEFT EYE
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    CYST ON HEAD
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CYTOPENIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CYTOPENIA LOW BLOOD COUNT PLATELETS 65 HAEMAGLOBIN 7.0
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    CYTOPENIC
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    2
    DAY/NIGHT SWEATS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DECREASE IN APPETITE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DECREASED APPETITE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DECREASED NEUTROPHILS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DECREASED PLATELETS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DECRESING NEUTROPHIL COUNT SINCE RECOMMENCING INTERFERON
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DEGENERATIVE CHANGES TO LEFT KNEE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DENTAL ABCESS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DENTAL ABCESS LEFT SIDE OF FACE
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DEPRESSED
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DEPRESSION
         subjects affected / exposed
    3 / 89 (3.37%)
    6 / 62 (9.68%)
    5 / 107 (4.67%)
         occurrences all number
    3
    6
    5
    DERANGED LIVER FUNCTION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DERANGED LIVER FUNCTION TESTS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DERMATOLOGY/SKIN OTHER: SKIN IRRITATION BUT NO RASH OR FLAKINESS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIABETES TYPE II
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DIAHORREA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    0
    2
    DIARRHEA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIARRHEOA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    0
    2
    DIARRHOEA
         subjects affected / exposed
    20 / 89 (22.47%)
    12 / 62 (19.35%)
    29 / 107 (27.10%)
         occurrences all number
    25
    18
    49
    DIARRHOEA & VOMITING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIARRHOEA & VOMITING.
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIARRHOEA - INTERMITTENT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIARRHOEA AND VOMITING BUG
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIARRHOEA EPISODES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIARRHOEA X2 EPISODES
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DIARRHOEA, NAUSEA AND DIZZINESS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIARRHOEA/NAUSEA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DIARROHEA
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DIFFUSE RASH
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DISCHARGE FROM EARS AND PUFFY EYES
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DISCOLORATION OF TEETH
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIVERTICULITIS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    0
    3
    DIVERTICULITIS (PREVIOUSLY REPORTED)
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIZZINESS
         subjects affected / exposed
    2 / 89 (2.25%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    2
    0
    3
    DIZZINESS/ SPINNING HEAD
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DIZZY
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DIZZYNESS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DROP IN COUNTS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DRY AND ITCHY EYES
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DRY COUGH
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    DRY EYELIDS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DRY EYES
         subjects affected / exposed
    3 / 89 (3.37%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    3
    0
    0
    DRY LIPS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DRY MOUTH
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DRY MOUTH AND DRY ITCHY SKIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    DRY PENIS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DRY SKIN
         subjects affected / exposed
    3 / 89 (3.37%)
    0 / 62 (0.00%)
    4 / 107 (3.74%)
         occurrences all number
    3
    0
    4
    DRY SKIN TO RIGHT AND LEFT SIDES OF FACE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DRY THROAT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    DRYNESS OF SCALP
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DULL ACHE IN THIGH
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DYSPEPSIA
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 62 (3.23%)
    5 / 107 (4.67%)
         occurrences all number
    0
    2
    5
    DYSPHAGIA
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    DYSPNEA
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    1
    DYSPNOEA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    1
    0
    2
    EAR ACHE
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    EAR INFECTION
         subjects affected / exposed
    3 / 89 (3.37%)
    4 / 62 (6.45%)
    1 / 107 (0.93%)
         occurrences all number
    3
    4
    1
    ECZEMA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ECZEMA ON FOREHEAD
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    2
    ECZEMA RIGHT AXILLA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ECZEMA TO CALF
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ECZEMATOUS RASH TO LEGS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ECZEMATOUS TYPE LESIONS ON BOTH PALMS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ELEVATED ALT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ELEVATED AST
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    3
    ELEVATED BILIRUBIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ELEVATED GAMMA GT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ELEVATED GGT
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ELEVATED LIVER FUNCTION TESTS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    EPIGASTRIC DISCOMFORT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    0
    0
    2
    EPIGASTRIC PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    EPIGASTRIC TENDERNESS
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 62 (3.23%)
    0 / 107 (0.00%)
         occurrences all number
    0
    2
    0
    EPISODE OF PASSING BLACK STOOLS FOR 4 DAYS (NOT SPECIFIED)
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    EPISODES OF CRAMP
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    EPISODES OF CRAMP TO TOES
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    EPISODIC EXPLSIVE DIARRHOEA
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    EPISTAXIS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ERECTILE DYSFUNCTION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ERYTHEMA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ERYTHEMA INJECTION SITE
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ERYTHEMA PEGASYS INJECTION SITE
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ERYTHEMATOUS CONFLUENT MACULAR RASH
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    EXACERBATION OF DIVERTICULITIS - ABDOMINAL PAIN AND DIARRHOEA
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    EXAMINATION IN PAIN BUT SEEMS VERY OUT OF PROPORTION TO LIKELY SPLENOMEGALY
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    EXCESSIVE PERSPIRATION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    EXCESSIVELY TIRED
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    EXTREMITY LIMB PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    EYE INFECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    EYE-WATERING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    EYES BLOOD SHOT
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FACE PAIN - AROUND JAW AREA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FACIAL ODEMA
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    2
    FACIAL OEDEMA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FACIAL OEDEMA (PERI-ORBITAL)
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FACIAL PUFFINESS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FACIAL RASH
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FACIAL SWELLING
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    2 / 107 (1.87%)
         occurrences all number
    0
    1
    3
    FACIAL SWELLING AROUND THE EYES
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FACIAL SWELLING IN MORNING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FAINTED
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FALL
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    FALL FROM STAIRS (DISLOCATED RIGHT ELBOW, BROKE 1 RIB)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FATIGUE
         subjects affected / exposed
    13 / 89 (14.61%)
    18 / 62 (29.03%)
    24 / 107 (22.43%)
         occurrences all number
    23
    24
    32
    FATIGUE -POST PEGASYS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FATIGUE/MUSCLE WEAKNESS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FATIGUR
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FATIQUE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FEELING 'COLD'
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FEELING BIT SICKLY AND VOMITED X1
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FEELING COLD
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FEELING HOT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FEELING LETHARGIC
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FEELING MORE MOODY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FEELING MORE TIRED
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FEELING TIRED & UNWELL
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FEELS TIRED & TENDS TO FALL ASLEEP EASILY, NOT GOT THE SAME ENERGY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FEET OEDEMA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FEINT WITH FALL,SORE RIGHT SHOULDER.
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FELT FAINT
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FELT SICK (SOMETIMES VOMIT)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FEVER
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 62 (3.23%)
    0 / 107 (0.00%)
         occurrences all number
    0
    2
    0
    FIBROMYALGIA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FINGER INFECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FINGER SWELLING
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FLASHING HEADACHES
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FLATULANCE
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FLORID ITCHING ERYTHEMATOUS SKIN : TRUNK BACK ARMS AND LEGS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FLORID TOTAL BODY RASH, NON ITCHY
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FLU
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FLU LIKE SYMPTOMS
         subjects affected / exposed
    1 / 89 (1.12%)
    5 / 62 (8.06%)
    0 / 107 (0.00%)
         occurrences all number
    1
    5
    0
    FLU LIKE SYMPTOMS FOLLOWING FIRST PEG INTERFERON INJECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FLU- LIKE SYMPTOMS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FLU-LIKE ILLNESS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FLU-LIKE SYNDROME
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FLUID RETENTION
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 62 (1.61%)
    3 / 107 (2.80%)
         occurrences all number
    2
    1
    6
    FLUID RETENTION AND WEIGHT GAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FLUID RETENTION TO EYES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FOLLICULAR RASH
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FOLLICULITIS FOREHEAD
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FOLLICULITIS RIGHT ARMPIT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FRACTURED LEFT FIFTH METATARSAL
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FRACTURED LEFT RADIUS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FRACTURED STERUM
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    FRACTURED TIP OF RIGHT LATERAL MALLEOLUS.
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FRESH BLEEDING WHEN OPENING BOWELS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FULLNESS RIGHT BREAST
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    FUNGAL RASH IN PERIANAL AND SCROTAL AREA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    FUNGAL SKIN INFECTION - LEFT SHIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    GALL STONES
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    GALLSTONES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GASTRIC IRRITATION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GASTROENERITIS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    GASTROENTERITIS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    GASTROINTESTINAL SYMPTOMS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    GASTROINTESTINAL UPSET
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GASTROINTESTINAL VIRAL INFECTION
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    GENERAL BODY ACHES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GENERAL MALAISE
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    GENERAL MALISE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    GENERAL WEAKNESS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GENERALISED ACHES AND PAINS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GENERALISED BODY ACHING - MUSCULAR
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GENERALISED BODY RASH
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    GENERALISED ITCH
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GENERALISED PRURITIS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    2
    0
    GENERALISED RASH
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GENERALISED SKIN RASH
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    GI URGENCY
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    GLOSSAL SWELLING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    2
    GOUT
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    1
    GOUT IN FINGERS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    GOUT IN LEFT ANKLE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    GRADE 1 MYALGIA, GENERALLY AFFECTING LEGS AND HIP AREAS.
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GRADE 2 TRANSAMINITIS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GRADE 3 HAEM TOXICITY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    GRADE 3 NEUTS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    GRADE 3 TOXICITY AST/ALT RESULTS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GRADE 3 TOXICITY PLATLETS AND NEUTROPHILS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GRADE 3 TOXICITY, NEUTROPHILS 0.3
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GRIPEY ABDOMINAL PAINS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    GRITTINESS AND DISCHARGE FROM EYES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GRITTY EYES
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    1
    1
    0
    GRITTY SKIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    GUM DISEASE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    HAEM TOXICITY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    3
    0
    HAEM TOXICITY - LOW PLATELATES - PROLONGED MENSES
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    HAEM TOXICITY PLATELETS GRADE 2 TOXICITY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    HAEMATEMESIS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HAEMATOLOGICAL TOXICITY
         subjects affected / exposed
    0 / 89 (0.00%)
    2 / 62 (3.23%)
    0 / 107 (0.00%)
         occurrences all number
    0
    3
    0
    HAEMATOLOGICAL TOXICITY THROMBOCYTOPAENIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HAEMATOLOGICAL TOXICITY WITH A NEUTROPHIL COUNT OF 0.8
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HAEMATOLOGICAL TOXICITY. PLATELETS 46
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HAEMATOMA FOLLOWING BONE MARROW
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    HAEMATUREA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    HAEMATURIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HAEMATURIA (URINE)
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HAEMOGLOBIN 80
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HAEMOPTYSIS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HAEMORRHOIDS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    HAIR LOSS
         subjects affected / exposed
    2 / 89 (2.25%)
    2 / 62 (3.23%)
    0 / 107 (0.00%)
         occurrences all number
    2
    2
    0
    HAIR THINNING
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    HALLUCINATIONS FOLLOWING INTERFERON INJECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    HEAD PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    HEADACHE
         subjects affected / exposed
    1 / 89 (1.12%)
    2 / 62 (3.23%)
    6 / 107 (5.61%)
         occurrences all number
    2
    2
    8
    HEADACHES
         subjects affected / exposed
    7 / 89 (7.87%)
    2 / 62 (3.23%)
    5 / 107 (4.67%)
         occurrences all number
    7
    2
    6
    HEADACHES (OCCASIONAL)
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HEADACHES AND ACHES AND PAINS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HEARING LOSS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HEARTBURN
         subjects affected / exposed
    2 / 89 (2.25%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    2
    0
    2
    HEAVY PERIODS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    HEPATIC - RAISED GGT
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    HEPATOTOXICITY
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HERPES SIMPLEX INFECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    HIATUS HERNIA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    HOT AND COLD EPISODES RECENTLY
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    HOT FLUSHES
         subjects affected / exposed
    1 / 89 (1.12%)
    3 / 62 (4.84%)
    0 / 107 (0.00%)
         occurrences all number
    1
    3
    0
    HOT FLUSHES/SWEATS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HYDROCELE/ PLICATION OF HYDROCELE SAC
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    HYPERCHOLESTEREAMIA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    HYPERSENSITIVE SKIN REACTION
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    HYPERTENSION
         subjects affected / exposed
    2 / 89 (2.25%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    2
    0
    2
    HYPOCALCAEMIA
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    1 / 107 (0.93%)
         occurrences all number
    0
    1
    1
    HYPOKALEMIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HYPOTHYROIDISM
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    HYSTERECTOMY
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INCREASE SWEATS, DAY AND NIGHT
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    INCREASED FATIGUE
         subjects affected / exposed
    2 / 89 (2.25%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    2
    0
    0
    INCREASED MUSCLE WEAKNESS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    INDIGESTION
         subjects affected / exposed
    3 / 89 (3.37%)
    0 / 62 (0.00%)
    10 / 107 (9.35%)
         occurrences all number
    4
    0
    12
    INFECTION
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INFECTION (CHEST)
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INFECTION - VAGINAL THRUSH
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    INFECTION WITH GRADE 1 NEUTROPHILS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    INFECTION WITH NORMAL ANC
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    INFECTION- BLADDER (URINARY TRACT)
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    3
    0
    INFLAMMED AND SWOLLEN EYELIDS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    INFLAMMED FACE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INFLAMMED RIGHT AND LEFT AXILLA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    INFLUENZA
         subjects affected / exposed
    2 / 89 (2.25%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    2
    0
    1
    INJURY TO RIGHT ELBOW
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INSOMNIA
         subjects affected / exposed
    3 / 89 (3.37%)
    3 / 62 (4.84%)
    5 / 107 (4.67%)
         occurrences all number
    5
    3
    5
    INSPIRATORY CREPITATIONS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INTERMITTANT CRAMPS IN VARIOUS PARTS OF BODY
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    INTERMITTANT DIARRHOEA, UNKNOWN ONSET DATE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INTERMITTANT HEADACHES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INTERMITTENT BURNIG SENSATION ON BACK OF HANDS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INTERMITTENT CENTRAL AND LEFT SIDED CHEST PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    INTERMITTENT CRAMPS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    INTERMITTENT CRAMPS IN JOINTS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INTERMITTENT DIARRHOEA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    INTERMITTENT HOT FLUSHES
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    INTERMITTENT MUSCLE CRAMPS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INTERMITTENT NAUSEA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    INTERMITTENT VOMITING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    INTERMITTENT VOMITING, MAINLY MORNING.
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    IRON DEFICIENCY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    IRON DEFICIENCY ANAEMIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    IRON DEFICIENT ANAEMIA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    IRREGULAR HEART BEAT - ECG AND ECHO NAD
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    IRRITABLE BOWEL
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    IRRITATION RIGHT EAR
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ITCHING BACK
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ITCHING IN LEFT FOOT
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ITCHING OVER THE SCALP AND LEFT LEG. ASSOCIATED WITH DRY SKIN
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ITCHING,ERYTHEMATOUS LOWER BACK, ARMS AND LEGS
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ITCHY PIMPLES
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    ITCHY RASH
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ITCHY RASH ON LEGS , FACE AND EARLOBES
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ITCHY SKIN
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ITCHY SKIN, DRY AND RED
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ITCHY SPOTS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    ITCHY, RED SKIN, RASH VISIBLE ON ARMS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    ITCY RASH ACROSS CHEST
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    JAUNDICE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    JOINT ACHE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    JOINT PAIN
         subjects affected / exposed
    3 / 89 (3.37%)
    0 / 62 (0.00%)
    2 / 107 (1.87%)
         occurrences all number
    3
    0
    2
    JOINT PAIN (ARTHRALGIA)
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    JOINT PAIN R HIP, GROIN AND SHOULDER
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    JOINT PAINS
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    1
    1
    0
    JOINT SWELLING
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    KERATOACANTHOMAS ( ONE SPOT ABOVE LIP)
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    KNEE PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LAMINAR MACULAR HOLE LEFT EYE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    LARGE BRUISE TO CHEST
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    LEFT EYE SUBCONJUNCTIVAL HAEMORRHAGE.
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    LEFT GROIN AND HIP PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    LEFT GROIN PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LEFT KNEES AND FEET ACHE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    LEFT LEG PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    LEFT LEG SWELLING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LEFT RETINAL DETACHMENT. REPAIRED SURGICALLY ON 5/09/2012.
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LEFT SHOULDER NERVE PAIN
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LEFT SHOULDER PAIN
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    LEFT UPPER QUADRANT DISCOMFORT
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    LEFT UPPER QUADRANT PAIN
         subjects affected / exposed
    2 / 89 (2.25%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    2
    0
    0
    LEG ACHE, ESPECIALLY IN KNEES
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LEG AND ARM CRAMPS
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LEG CRAMPS
         subjects affected / exposed
    7 / 89 (7.87%)
    1 / 62 (1.61%)
    6 / 107 (5.61%)
         occurrences all number
    7
    1
    6
    LEG CRAMPS (ON AND OFF) WHEN DRUGS COMMENCED
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LEG CRAMPS,
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LEG OEDEMA
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    LEG PAIN - SEVERE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LEG SWELLING
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    LEGACHE
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    0 / 107 (0.00%)
         occurrences all number
    1
    0
    0
    LEGS ACHE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LETHAGY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    LETHARGY
         subjects affected / exposed
    3 / 89 (3.37%)
    3 / 62 (4.84%)
    6 / 107 (5.61%)
         occurrences all number
    3
    4
    7
    LETHARGY, MALAISE
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LETHERGY
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    LETHERGY/TIREDNESS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    LEUCOPENIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LEUKOPENIA
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LIGHT HEADED
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    1
    0
    1
    LIGHT HEADED AND UNABLE TO TALK FOR 30 SES. NO TRUE LOC. BACK TO NORMAL WITHIN 2 MINS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    LIGHTHEADED
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LIGHTHEADEDNESS
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number
    0
    1
    0
    LIP SWELLING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LIP SWELLING AND TONGUE TIGHTENING
         subjects affected / exposed
    0 / 89 (0.00%)
    0 / 62 (0.00%)
    1 / 107 (0.93%)
         occurrences all number
    0
    0
    1
    LOCAL SKIN REACTION - REDNESS AND SLIGHT SWELLING AT INJECTION SITES
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 62 (1.61%)
    0 / 107 (0.00%)
         occurrences all number</