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    Clinical Trial Results:
    10-day decitabine versus conventional chemotherapy (“3+7”) followed by allografting in AML patients 60+ years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group

    Summary
    EudraCT number
    		 2014-001486-27
    Trial protocol
    		 BE   DE   PT   LT   SK   BG   NL   IT   FR  
    Global end of trial date
    29 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2024
    First version publication date
    18 Aug 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1301-LG
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02172872
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    European Organisaton for the Research and Treatment of Cancer (EORTC)
    Sponsor organisation address
    Av E. Mounier 83/11, Brussels, Belgium,
    Public contact
    Clinical Operations Department, European Organisaton for the Research and Treatment of Cancer (EORTC) , +32 27741072, regulatory@eortc.org
    Scientific contact
    Clinical Operations Department, European Organisaton for the Research and Treatment of Cancer (EORTC) , +32 27741072, regulatory@eortc.org
    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
    07 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (“3+7”) on overall survival (OS) in older AML patients.
    Protection of trial subjects
    This study was conducted in agreement with the Declaration of Helsinki and the laws and regulations of the participating countries. The protocol has been written and the study conducted according to the ICH Harmonized Tripartite Guideline on Good Clinical Practice. The protocol has been approved by the competent ethics committee(s) as required by the applicable national legislation.
    Background therapy
    		 -
    Evidence for comparator
    		 The combination of cytarabine and an anthracycline has been the standard of care for patients with AML for the last 4 decades. However, the application of this regimen in the elderly population does not yield similar results to those reported for younger patients. In the HOVON43 study, patients 60 years of age or older were randomly assigned to receive cytarabine at a dose of 200 mg/m2 by continuous infusion for 7 days plus daunorubicin for 3 days, either at the conventional dose of 45 mg/m2 or at an escalated dose of 90 mg/m2. The OS was similar between the two groups and the median OS of all included patients was estimated to be about 11 months. In the EORTC-GIMEMA AML-17 study conducted in older AML patients, the median OS was 10 months in the standard arm (MICE followed by 2 x mini-ICE) .
    Actual start date of recruitment
    31 Oct 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 140
    Country: Number of subjects enrolled
    Portugal: 5
    Country: Number of subjects enrolled
    Belgium: 33
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    France: 62
    Country: Number of subjects enrolled
    Germany: 161
    Country: Number of subjects enrolled
    Italy: 154
    Country: Number of subjects enrolled
    Lithuania: 27
    Country: Number of subjects enrolled
    Croatia: 22
    Worldwide total number of subjects
    606
    EEA total number of subjects
    606
    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)
    151
    From 65 to 84 years
    455
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 2014 and 2019, 606 patients were enrolled.

    Pre-assignment
    Screening details
    		 In total, 633 patients were screened for eligibility.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Decitabine
    Arm description
    		 Decitabine according to the 10-day schedule
    Arm type
    		 Experimental

    Investigational medicinal product name
    Decitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    20 mg/m2 via a one hour infusion on ten consecutive days in each cycle of 28 days. During cycles 2 and 3, reduced to 5 days in case of a remission (<5% blasts in the bone marrow). From cycle 4 onwards, reduced to 5 days, as long as there is no evidence of progression.

    Arm title
    		 "3+7"
    Arm description
    		 Standard chemotherapy
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Daunorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    60 mg/m2 on days 1, 2, 3 during cycle 1 and 45 mg/m2 on days 1, 2, 3 during cycle 2.

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    200 mg/m2 continuous infusion (24 hours) during days 1-7 of cycles 1 and 2.

    Number of subjects in period 1
    		Decitabine "3+7"
    Started
    303
    303
    Completed
    303
    303
    Period 2
    Period 2 title
    Protocol treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Decitabine
    Arm description
    		 Decitabine according to the 10-day schedule
    Arm type
    		 Experimental

    Investigational medicinal product name
    Decitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    20 mg/m2 via a one hour infusion on ten consecutive days in each cycle of 28 days. During cycles 2 and 3, reduced to 5 days in case of a remission (<5% blasts in the bone marrow). From cycle 4 onwards, reduced to 5 days, as long as there is no evidence of progression.

    Arm title
    		 "3+7"
    Arm description
    		 Standard chemotherapy
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Daunorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    60 mg/m2 on days 1, 2, 3 during cycle 1 and 45 mg/m2 on days 1, 2, 3 during cycle 2.

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    200 mg/m2 continuous infusion (24 hours) during days 1-7 of cycles 1 and 2.

    Number of subjects in period 2 [1]
    		Decitabine "3+7"
    Started
    302
    298
    Completed
    123
    143
    Not completed
    179
    155
         Toxicity
    14
    44
         Other
    4
    8
         Death not due to AML or toxicity
    6
    4
         Treatment failure/relapse
    129
    61
         Treatment failure and toxicity
    4
    5
         Other malignancy
    3
    -
         Patient's decision
    11
    14
         Start of new treatment
    8
    19
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 1 patient in the decitabine arm and 5 patients in the 3+7 arm did not start the protocol treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomization
    Reporting group description
    		 -

    Reporting group values
    		 Randomization Total
    Number of subjects
    		 606 606
    Age categorical
    Units: Subjects
        60-64
    		 151 151
        65-69
    		 251 251
        70 or older
    		 204 204
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 68 (60 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 258 258
        Male
    		 345 345
        Unknown
    		 3 3
    ELN 2017
    Units: Subjects
        Favorable
    		 115 115
        Intermediate
    		 257 257
        Adverse
    		 178 178
        Missing
    		 56 56

    End points

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    End points reporting groups
    Reporting group title
    Decitabine
    Reporting group description
    		 Decitabine according to the 10-day schedule

    Reporting group title
    "3+7"
    Reporting group description
    		 Standard chemotherapy
    Reporting group title
    Decitabine
    Reporting group description
    		 Decitabine according to the 10-day schedule

    Reporting group title
    "3+7"
    Reporting group description
    		 Standard chemotherapy

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients

    Subject analysis set title
    Patients who achieved CR/CRi
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This set included patients who achieved CR/CRi during the protocol treatment and was used to describe outcomes from reaching CR/CRi.

    Subject analysis set title
    Patients who were allografted
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This set included patients who underwent allo-HSCT and was used to describe outcomes after allo-HSCT.

    Primary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Time from randomization to death.
    End point type
    Primary
    End point timeframe
    From randomization
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    303
    303
    Units: % at 4 years
        number (confidence interval 95%)
    26.0 (20.8 to 31.5)
    29.7 (24.3 to 35.3)
    Statistical analysis title
    		 Primary OS analysis
    Comparison groups
    Decitabine v "3+7"
    Number of subjects included in analysis
    606
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.26

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Time from randomization to progression or death, whichever comes first.
    End point type
    Secondary
    End point timeframe
    From randomization
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    303
    303
    Units: % at 4 years
        number (confidence interval 95%)
    22.5 (17.6 to 27.7)
    23.9 (18.7 to 29.5)
    Statistical analysis title
    		 Primary PFS analysis
    Comparison groups
    Decitabine v "3+7"
    Number of subjects included in analysis
    606
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.32

    Secondary: Overall CR/CRi

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    End point title
    		 Overall CR/CRi
    End point description
    Documented CR/CRi during protocol or post-protocol treatments prior to allografting.
    End point type
    Secondary
    End point timeframe
    Protocol or post-protocol treatments prior to allografting
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    303
    303
    Units: Yes or no based on ELN 2017 cirteria
        CR/CRi
    183
    203
        No CR/CRi
    120
    100
    Statistical analysis title
    		 Primary overall CR/CRi rate analysis
    Statistical analysis description
    Values of the odds ratio lower than 1 indicate a higher probability of CR/CRi in the 3+7 arm.
    Comparison groups
    Decitabine v "3+7"
    Number of subjects included in analysis
    606
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.05

    Secondary: CR/CRi

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    End point title
    		 CR/CRi
    End point description
    Documented CR/CRi during protocol treatment prior to allografting.
    End point type
    Secondary
    End point timeframe
    During protocol treatment prior to allografting
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    303
    303
    Units: Yes versus no based on ELN 2017 criteria
        CR/CRi
    145
    186
        No CR/CRi
    158
    117
    Statistical analysis title
    		 Primary CR/CRi rate analysis
    Statistical analysis description
    Values of the odds ratio smaller than 1 indicate a higher probability of reaching CR/CRi in the 3+7 arm.
    Comparison groups
    Decitabine v "3+7"
    Number of subjects included in analysis
    606
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 0.8

    Secondary: Response

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    End point title
    		 Response
    End point description
    Documented response during protocol treatment prior to allografting.
    End point type
    Secondary
    End point timeframe
    During protocol treatment prior to allografting
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    303
    303
    Units: Yes or no based on ELN 2017
        PR, MLFS, or CR/CRi
    173
    204
        No PR, MLFS, or CR/CRi
    130
    99
    Statistical analysis title
    		 Primary response analysis
    Statistical analysis description
    Values of the odds ratio smaller than 1 indicate a higher probability of response in the 3+7 arm.
    Comparison groups
    Decitabine v "3+7"
    Number of subjects included in analysis
    606
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 0.9

    Secondary: Allografting

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    End point title
    		 Allografting
    End point description
    Undergoing allo-HSCT following decitabine or 3+7.
    End point type
    Secondary
    End point timeframe
    Protocol treatment
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    303
    303
    Units: Yes versus no
        Allografting as a part of the protocol treatment
    122
    118
        No allografting as a part of the protocol
    181
    185
    No statistical analyses for this end point

    Secondary: Duration of hospitalization

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    End point title
    		 Duration of hospitalization
    End point description
    The number of days of hospitalization during the first 3 cycles of the treatment. This information was collected only in a subgroup of patients.
    End point type
    Secondary
    End point timeframe
    Cycles 1, 2, and 3
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    89
    84
    Units: Days
        arithmetic mean (inter-quartile range (Q1-Q3))
    40 (21 to 60)
    52 (33 to 63)
    No statistical analyses for this end point

    Secondary: Disease-free survival from CR/CRi

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    End point title
    		 Disease-free survival from CR/CRi
    End point description
    Time between CR/CRi and relapse or death, whichever occurred first. This endpoint was analyzed among patients who achieved CR/CRi during the protocol treatment and prior to allografting.
    End point type
    Secondary
    End point timeframe
    From CR/CRi
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    145
    186
    Units: % at 4 years
        number (confidence interval 95%)
    27.6 (19.7 to 36.1)
    31.8 (24.5 to 39.4)
    No statistical analyses for this end point

    Secondary: Time to relapse from CR/CRi

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    End point title
    		 Time to relapse from CR/CRi
    End point description
    Time to relapse from CR/CRi. Death without a relapse was treated as a competing event in the analysis. This endpoint was analyzed among patients who achieved CR/CRi during the protocol treatment and prior to allografting.
    End point type
    Secondary
    End point timeframe
    From CR/CRi
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    145
    186
    Units: % with a relapse at 4 years
        number (confidence interval 95%)
    52.2 (42.8 to 60.7)
    42.5 (34.7 to 50.2)
    No statistical analyses for this end point

    Secondary: Time to death without relapse from CR/CRi

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    End point title
    		 Time to death without relapse from CR/CRi
    End point description
    Time to death without relapse from CR/CRi. Relapse was treated as a competing event in the analysis. This endpoint was analyzed among patients who achieved CR/CRi during the protocol treatment and prior to allografting.
    End point type
    Secondary
    End point timeframe
    From CR/CRi
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    145
    186
    Units: % who died without relapse at 4 years
        number (confidence interval 95%)
    20.2 (13.8 to 27.6)
    25.6 (19.3 to 32.4)
    No statistical analyses for this end point

    Secondary: PFS from allo-HSCT

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    End point title
    		 PFS from allo-HSCT
    End point description
    Time to progression or death from allo-HSCT, whichever occurred first. This endpoint was analyzed among patients who received allo-HSCT as a part of the protocol treatment.
    End point type
    Secondary
    End point timeframe
    From allo-HSCT
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    122
    118
    Units: % at 4 years
        number (confidence interval 95%)
    45.2 (35.1 to 54.7)
    44.2 (34.3 to 53.7)
    No statistical analyses for this end point

    Secondary: Time to progression from allo-HSCT

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    End point title
    		 Time to progression from allo-HSCT
    End point description
    This endpoint was analyzed among patients who received allo-HSCT as a part of the protocol treatment. Death without progression was treated as a competing event in the analysis.
    End point type
    Secondary
    End point timeframe
    From allo-HSCT
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    122
    118
    Units: % with a progression at 4 years
        number (confidence interval 95%)
    23.8 (16.4 to 31.9)
    22.4 (14.8 to 31.0)
    No statistical analyses for this end point

    Secondary: Time to death without progression from allo-HSCT

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    End point title
    		 Time to death without progression from allo-HSCT
    End point description
    This endpoint was analyzed among patients who received allo-HSCT as a part of the protocol treatment. Progression was treated as a competing event in the analysis.
    End point type
    Secondary
    End point timeframe
    From allo-HSCT
    End point values
    		 Decitabine "3+7"
    Number of subjects analysed
    122
    118
    Units: % who died without progression
        number (confidence interval 95%)
    31.1 (22.1 to 40.4)
    33.4 (24.5 to 42.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Information about all adverse events was collected between randomization and 30 days after last dose of the protocol drug treatment (decitabine or 3+7) or first day of hospitalization for transplantation, whichever occurred first.
    Adverse event reporting additional description
    Information about SAEs related to the transplantation procedure concerning graft failure, SOS, grade 3-4 infections, and toxic deaths was reported until the end of the study. Information about SAEs related to the protocol drug treatment decitabine or 3+7 was reported until the end of the study as well.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    "3+7"
    Reporting group description
    		 -

    Reporting group title
    Decitabine
    Reporting group description
    		 -

    Serious adverse events
    		 "3+7" Decitabine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    125 / 298 (41.95%)
    160 / 302 (52.98%)
         number of deaths (all causes)
    221
    230
         number of deaths resulting from adverse events
    51
    41
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ACUTE MYELOID LEUKAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    INVASIVE BREAST CARCINOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MIXED ADENONEUROENDOCRINE CARCINOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    RENAL CANCER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL CELL CARCINOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    UTERINE CANCER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Vascular disorders
    VENOOCCLUSIVE DISEASE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    VASCULITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOPHLEBITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBCLAVIAN VEIN THROMBOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PHLEBITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL ISCHAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ORTHOSTATIC HYPOTENSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EMBOLISM
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEEP VEIN THROMBOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    EUTHANASIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    CHEST PAIN
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASTHENIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYST
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE RELATED THROMBOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    MUCOSAL INFLAMMATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MULTIPLE ORGAN DYSFUNCTION SYNDROME
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    17 / 298 (5.70%)
    10 / 302 (3.31%)
         occurrences causally related to treatment / all
    15 / 17
    7 / 10
         deaths causally related to treatment / all
    15 / 17
    7 / 10
    PYREXIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUDDEN DEATH
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    DEATH
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Immune system disorders
    GRAFT VERSUS HOST DISEASE IN LIVER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE GRAFT VERSUS HOST DISEASE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    2 / 2
    ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    ACUTE GRAFT VERSUS HOST DISEASE IN LIVER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    ANAPHYLACTIC REACTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC GRAFT VERSUS HOST DISEASE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    GRAFT VERSUS HOST DISEASE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    7 / 302 (2.32%)
         occurrences causally related to treatment / all
    1 / 1
    6 / 7
         deaths causally related to treatment / all
    0 / 0
    6 / 7
    GRAFT VERSUS HOST DISEASE IN GASTROINTESTINAL TRACT
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    4 / 302 (1.32%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    4 / 4
    GRAFT VERSUS HOST DISEASE IN LUNG
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GRAFT VERSUS HOST DISEASE IN SKIN
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    INTERSTITIAL LUNG DISEASE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IDIOPATHIC PNEUMONIA SYNDROME
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPNOEA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE RESPIRATORY FAILURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    1 / 2
    ACUTE RESPIRATORY DISTRESS SYNDROME
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    ACUTE PULMONARY OEDEMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 298 (1.01%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    1 / 3
    0 / 0
    ORGANISING PNEUMONIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 298 (1.01%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    PULMONARY ALVEOLAR HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY OEDEMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    PULMONARY VASCULITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY VENO-OCCLUSIVE DISEASE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    RESPIRATORY DISTRESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY FAILURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    6 / 298 (2.01%)
    7 / 302 (2.32%)
         occurrences causally related to treatment / all
    2 / 6
    1 / 7
         deaths causally related to treatment / all
    2 / 4
    1 / 5
    PLEURAL EFFUSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    DELIRIUM
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DELUSIONAL DISORDER, UNSPECIFIED TYPE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    TRANSAMINASES INCREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPHIL COUNT DECREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD CREATININE INCREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    SPINAL COMPRESSION FRACTURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPLENIC RUPTURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEMUR FRACTURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FALL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXTRADURAL HAEMATOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    INJURY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSPLANT FAILURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Congenital, familial and genetic disorders
    HEART DISEASE CONGENITAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    SINUS BRADYCARDIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARRHYTHMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL TACHYCARDIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC ARREST
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    4 / 302 (1.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    CARDIAC FAILURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 298 (1.01%)
    6 / 302 (1.99%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 6
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    CARDIAC FAILURE CONGESTIVE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    DILATED CARDIOMYOPATHY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCARDIAL INFARCTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCARDIAL ISCHAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERICARDITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RIGHT VENTRICULAR DYSFUNCTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STRESS CARDIOMYOPATHY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOXIC CARDIOMYOPATHY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULAR FIBRILLATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TACHYCARDIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    DIZZINESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    CEREBROVASCULAR ACCIDENT
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    1 / 2
    TOXIC ENCEPHALOPATHY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYNCOPE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBARACHNOID HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OPTIC NEURITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEMORY IMPAIRMENT
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ISCHAEMIC STROKE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    HEPATIC ENCEPHALOPATHY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGE INTRACRANIAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 298 (1.01%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BONE MARROW FAILURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    FEBRILE NEUTROPENIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    26 / 302 (8.61%)
         occurrences causally related to treatment / all
    3 / 3
    24 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LEUKOCYTOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    LEUKOSTASIS SYNDROME
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    5 / 302 (1.66%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 5
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    PANCYTOPENIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    SPLENIC HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEBRILE BONE MARROW APLASIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    5 / 302 (1.66%)
         occurrences causally related to treatment / all
    1 / 1
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ANORECTAL DISORDER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    CONSTIPATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCOLITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    GASTROINTESTINAL HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    GASTROINTESTINAL INFLAMMATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARGE INTESTINAL OBSTRUCTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARGE INTESTINE PERFORATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NAUSEA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIC COLITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    PANCREATITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PEPTIC ULCER HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS ACUTE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLESTASIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG-INDUCED LIVER INJURY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    HEPATIC FAILURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    PORTAL HYPERTENSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    ACUTE FEBRILE NEUTROPHILIC DERMATOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    RENAL FAILURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 298 (1.01%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    CYSTITIS HAEMORRHAGIC
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC KIDNEY DISEASE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE KIDNEY INJURY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYALGIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    CYTOMEGALOVIRUS COLITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    ANAL ABSCESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAL INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTHRITIS BACTERIAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASPERGILLUS INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERIAL INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERIAL SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    BRONCHITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHOPULMONARY ASPERGILLOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CANDIDA INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CAT SCRATCH DISEASE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLOSTRIDIUM DIFFICILE COLITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLOSTRIDIUM DIFFICILE INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORYNEBACTERIUM SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYSTITIS VIRAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYTOMEGALOVIRUS INFECTION REACTIVATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    DEVICE RELATED INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    ECTHYMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    ENCEPHALITIS VIRAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    ENTEROBACTER SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCOCCAL BACTERAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    ENTEROCOCCAL SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    EPSTEIN-BARR VIRUS INFECTION REACTIVATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA BACTERAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    FUNGAL INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS CLOSTRIDIAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GROIN INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC INFECTION FUNGAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    HEPATOSPLENIC CANDIDIASIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERPES VIRUS INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFLUENZA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    KLEBSIELLA BACTERAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION FUNGAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUSITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SERRATIA INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPTIC SHOCK
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    20 / 298 (6.71%)
    9 / 302 (2.98%)
         occurrences causally related to treatment / all
    15 / 21
    6 / 9
         deaths causally related to treatment / all
    8 / 10
    4 / 6
    SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    27 / 298 (9.06%)
    20 / 302 (6.62%)
         occurrences causally related to treatment / all
    29 / 31
    13 / 20
         deaths causally related to treatment / all
    15 / 17
    6 / 11
    RESPIRATORY SYNCYTIAL VIRUS INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    PULMONARY MUCORMYCOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    PSEUDOMONAS INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PSEUDOMONAL SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    PNEUMONIA FUNGAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    PNEUMONIA ESCHERICHIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    PNEUMONIA BACTERIAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    PNEUMONIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    25 / 298 (8.39%)
    27 / 302 (8.94%)
         occurrences causally related to treatment / all
    19 / 26
    22 / 30
         deaths causally related to treatment / all
    10 / 11
    3 / 8
    PNEUMOCYSTIS JIROVECII PNEUMONIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMOCYSTIS JIROVECII INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    PERITONITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIC SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIC INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE ABSCESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG ABSCESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL UPPER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UROSEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION BACTERIAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOOTH INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOOTH ABSCESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TESTICULAR ABSCESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYSTEMIC MYCOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 298 (1.01%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    1 / 2
    STREPTOCOCCAL SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STREPTOCOCCAL INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STOMATOCOCCAL INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STAPHYLOCOCCAL SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    STAPHYLOCOCCAL INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 302 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    HYPOKALAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    4 / 302 (1.32%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERNATRAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    DEHYDRATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DECREASED APPETITE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LACTIC ACIDOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    HYPERVOLAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 "3+7" Decitabine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    284 / 298 (95.30%)
    285 / 302 (94.37%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ENDOCRINE DISORDERS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    EPIDURAL CYST LESION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    NEOPLASMS MALIGNANT
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    ANEURYSMA ASCENDENS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    CALCIFIC PLAQUE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    CAPILLARY LEAK SYNDROME
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    FLUSHING
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    HEMATOMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    7 / 298 (2.35%)
    12 / 302 (3.97%)
         occurrences all number
    7
    14
    HOT FLASHES
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    3 / 302 (0.99%)
         occurrences all number
    3
    3
    HYPERTENSION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    15 / 298 (5.03%)
    19 / 302 (6.29%)
         occurrences all number
    17
    19
    HYPOTENSION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    6 / 298 (2.01%)
    6 / 302 (1.99%)
         occurrences all number
    8
    6
    LYMPHEDEMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    1 / 302 (0.33%)
         occurrences all number
    5
    1
    PERIPHERAL ISCHEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PHLEBITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    7 / 302 (2.32%)
         occurrences all number
    3
    7
    PSEUDOANEURYSM
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    SUPERFICIAL THROMBOPHLEBITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    2 / 302 (0.66%)
         occurrences all number
    5
    2
    THROMBOEMBOLIC EVENT
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    15 / 298 (5.03%)
    10 / 302 (3.31%)
         occurrences all number
    17
    11
    VASCULITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    1 / 302 (0.33%)
         occurrences all number
    4
    1
    VARICOSE VEIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    FEVER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    80 / 298 (26.85%)
    58 / 302 (19.21%)
         occurrences all number
    127
    79
    BLEEDING ON CENTRAL VENOUS CATHETER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    CHILLS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    2 / 302 (0.66%)
         occurrences all number
    5
    2
    DECREASED INDEPENDENCE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    DECREASED MOBILITY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    EDEMA FACE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences all number
    3
    0
    EDEMA LIMBS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    51 / 298 (17.11%)
    31 / 302 (10.26%)
         occurrences all number
    64
    39
    FACIAL PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    FATIGUE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    29 / 298 (9.73%)
    41 / 302 (13.58%)
         occurrences all number
    41
    56
    FLU LIKE SYMPTOMS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences all number
    1
    3
    GENERAL DETERIORATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    1 / 302 (0.33%)
         occurrences all number
    7
    1
    GENERAL EDEMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    INFUSION RELATED REACTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    6 / 298 (2.01%)
    2 / 302 (0.66%)
         occurrences all number
    8
    2
    INFUSION SITE EXTRAVASATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    INJECTION SITE REACTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    5 / 302 (1.66%)
         occurrences all number
    3
    6
    IRRITABILITY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    LOCALIZED EDEMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    6 / 298 (2.01%)
    6 / 302 (1.99%)
         occurrences all number
    7
    8
    MALAISE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    9 / 302 (2.98%)
         occurrences all number
    4
    13
    NON-CARDIAC CHEST PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    9 / 298 (3.02%)
    6 / 302 (1.99%)
         occurrences all number
    9
    6
    PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    4 / 302 (1.32%)
         occurrences all number
    4
    4
    PAIN (AFTER SURGERY)
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PROGRESSIVE DISEASE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    2
    ULCER IN PICC SITE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    GAIT DISTURBANCE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    Immune system disorders
    GRAFT VERSUS HOST DISEASE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    3 / 302 (0.99%)
         occurrences all number
    6
    4
    ALLERGIC REACTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    16 / 298 (5.37%)
    12 / 302 (3.97%)
         occurrences all number
    21
    12
    ALLO PLATELET IMMUNIZATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    ANAPHYLAXIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    CYTOKINE RELEASE SYNDROME
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    INFLAMMATORY SYNDROME
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    IMMUNE SYSTEM DISORDER (ERYTHEMA NODOSUM)
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    LESION OEDEMATOUS OF PUBIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    GYNECOMASTIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    GENITAL EDEMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    FEMALE GENITAL TRACT FISTULA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    MENORRHAGIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PELVIC PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PROSTATIC HYPERPLASIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    VAGINAL INFLAMMATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    TESTICULAR DISORDER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PROSTATIC PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PROSTATIC OBSTRUCTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PROSTATIC HYPERTROPHY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    PLEURAL EFFUSION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    13 / 298 (4.36%)
    16 / 302 (5.30%)
         occurrences all number
    13
    18
    PHARYNGOLARYNGEAL PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PHARYNGEAL MUCOSITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    NASAL CONGESTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    2 / 302 (0.66%)
         occurrences all number
    2
    2
    LARYNGEAL MUCOSITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    LARYNGEAL INFLAMMATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    HYPOXIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    7 / 298 (2.35%)
    4 / 302 (1.32%)
         occurrences all number
    7
    4
    HOARSENESS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    HICCUPS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences all number
    3
    0
    HEMOPTYSIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    GRANULOMA OF THE LUNG
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    EPISTAXIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    26 / 298 (8.72%)
    28 / 302 (9.27%)
         occurrences all number
    34
    45
    DYSPNEA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    23 / 298 (7.72%)
    37 / 302 (12.25%)
         occurrences all number
    25
    44
    CREPITATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    COUGH
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    8 / 298 (2.68%)
    21 / 302 (6.95%)
         occurrences all number
    8
    25
    COPD EXACERBATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    ASPIRATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    1 / 302 (0.33%)
         occurrences all number
    4
    1
    ALLERGIC RHINITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    ADULT RESPIRATORY DISTRESS SYNDROME
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences all number
    1
    2
    SORE THROAT
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    4 / 302 (1.32%)
         occurrences all number
    2
    4
    PULMONARY MICRONODULES
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PULMONARY INTERSTITIAL SYNDROM
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PULMONARY EDEMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    7 / 298 (2.35%)
    10 / 302 (3.31%)
         occurrences all number
    7
    10
    PRODUCTIVE COUGH
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    PNEUMOTHORAX
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    PNEUMONITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    7 / 298 (2.35%)
    6 / 302 (1.99%)
         occurrences all number
    8
    6
    PLEURITIC PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    PSYCHIATRIC DISORDERS NOS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    MANIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    INSOMNIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    7 / 298 (2.35%)
    8 / 302 (2.65%)
         occurrences all number
    8
    9
    HALLUCINATIONS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    2 / 302 (0.66%)
         occurrences all number
    4
    2
    DEPRESSION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    3 / 302 (0.99%)
         occurrences all number
    3
    4
    DELIRIUM
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    5 / 302 (1.66%)
         occurrences all number
    4
    6
    CONFUSION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    5 / 302 (1.66%)
         occurrences all number
    7
    6
    ANXIETY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    7 / 298 (2.35%)
    3 / 302 (0.99%)
         occurrences all number
    7
    3
    AGITATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences all number
    1
    2
    Investigations
    URINE OUTPUT DECREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PLATELET COUNT INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PLATELET COUNT DECREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    92 / 298 (30.87%)
    75 / 302 (24.83%)
         occurrences all number
    326
    202
    NEUTROPHIL COUNT DECREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    39 / 298 (13.09%)
    57 / 302 (18.87%)
         occurrences all number
    93
    143
    LYMPHOCYTE COUNT DECREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences all number
    4
    0
    HYPERFERRITINEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    GGT INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    23 / 298 (7.72%)
    23 / 302 (7.62%)
         occurrences all number
    39
    40
    FIBRINOGEN DECREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    EJECTION FRACTION DECREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    D DIMERE INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    CRP INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    19 / 298 (6.38%)
    16 / 302 (5.30%)
         occurrences all number
    23
    23
    CREATININE INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    10 / 298 (3.36%)
    6 / 302 (1.99%)
         occurrences all number
    15
    11
    CARDIAC TROPONIN T INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    BLOOD BILIRUBIN INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    8 / 298 (2.68%)
    8 / 302 (2.65%)
         occurrences all number
    11
    15
    ASPARTATE AMINOTRANSFERASE INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    12 / 298 (4.03%)
    16 / 302 (5.30%)
         occurrences all number
    14
    21
    ANTITHROMBIN DECREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    ALKALINE PHOSPHATASE INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    13 / 298 (4.36%)
    8 / 302 (2.65%)
         occurrences all number
    22
    11
    ALANINE AMINOTRANSFERASE INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    13 / 298 (4.36%)
    20 / 302 (6.62%)
         occurrences all number
    19
    31
    ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    WHITE BLOOD CELL DECREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    9 / 298 (3.02%)
    8 / 302 (2.65%)
         occurrences all number
    17
    16
    WEIGHT LOSS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    99 / 298 (33.22%)
    97 / 302 (32.12%)
         occurrences all number
    125
    121
    WEIGHT GAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    17 / 298 (5.70%)
    13 / 302 (4.30%)
         occurrences all number
    23
    13
    Injury, poisoning and procedural complications
    BRAIN TRAUMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    BRUISING
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 302 (0.99%)
         occurrences all number
    0
    4
    FALL
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    9 / 298 (3.02%)
    5 / 302 (1.66%)
         occurrences all number
    11
    5
    FRACTURE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    INJURY RIGHT HAND
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    INTRAOPERATIVE RESPIRATORY INJURY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    POSTOPERATIVE HEMORRHAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    SEROMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    SPINAL FRACTURE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    WRIST FRACTURE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    TACROLIMUS OVERDOSE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    TRACHEAL OBSTRUCTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    VASCULAR ACCESS COMPLICATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    2 / 302 (0.66%)
         occurrences all number
    3
    2
    Cardiac disorders
    PALPITATIONS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    ACUTE CORONARY SYNDROME
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    ATRIAL FIBRILLATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    21 / 298 (7.05%)
    15 / 302 (4.97%)
         occurrences all number
    25
    15
    ATRIAL FLUTTER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences all number
    1
    2
    CHEST PAIN - CARDIAC
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    DILATATIVE CARDIOMYOPATHY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    ECG ALTERATION/ NEGATIVE P WAVES
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    EXTRASYSTOLES
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    HEART FAILURE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    6 / 302 (1.99%)
         occurrences all number
    4
    8
    LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    MITRAL VALVE DISEASE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    MYOCARDIAL INFARCTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    PAROXYSMAL ATRIAL TACHYCARDIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    RESTRICTIVE CARDIOMYOPATHY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    RIGHT VENTRICULAR DYSFUNCTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    SINUS BRADYCARDIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    SINUS TACHYCARDIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    4 / 302 (1.32%)
         occurrences all number
    4
    4
    SUPRAVENTRICULAR TACHYCARDIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    TACHYCARDIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    TRICUSPID VALVE DISEASE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    VENTRICULAR TACHYCARDIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    PERICARDIAL EFFUSION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    5 / 302 (1.66%)
         occurrences all number
    2
    5
    Nervous system disorders
    CENTRAL NERVOUS SYSTEM
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    COGNITIVE DISTURBANCE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    DEPRESSED LEVEL OF CONSCIOUSNESS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    VASOVAGAL REACTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    DIZZINESS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    14 / 302 (4.64%)
         occurrences all number
    2
    15
    TRANSIENT ISCHEMIC ATTACKS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    SYNCOPE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    9 / 298 (3.02%)
    6 / 302 (1.99%)
         occurrences all number
    9
    6
    STROKE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    SOMNOLENCE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    SINUS PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    SEIZURE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    PRESYNCOPE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PERIPHERAL SENSORY NEUROPATHY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    2 / 302 (0.66%)
         occurrences all number
    5
    2
    PERIPHERAL MOTOR NEUROPATHY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    PARESTHESIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    3 / 302 (0.99%)
         occurrences all number
    2
    3
    OLFACTORY NERVE DISORDER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    NEURALGIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    MEMORY IMPAIRMENT
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    LETHARGY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    INTRACRANIAL HEMORRHAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    2 / 302 (0.66%)
         occurrences all number
    3
    2
    HYPERSOMNIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    HEADACHE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    37 / 298 (12.42%)
    28 / 302 (9.27%)
         occurrences all number
    47
    31
    EXTRAPYRAMIDAL DISORDER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    ENCEPHALOPATHY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    EDEMA CEREBRAL
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    DYSGEUSIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    3 / 302 (0.99%)
         occurrences all number
    5
    3
    DYSARTHRIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    TREMOR
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    ANEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    77 / 298 (25.84%)
    76 / 302 (25.17%)
         occurrences all number
    327
    303
    DISSEMINATED INTRAVASCULAR COAGULATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    FEBRILE NEUTROPENIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    170 / 298 (57.05%)
    87 / 302 (28.81%)
         occurrences all number
    282
    130
    LEUKOCYTOSIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    LYMPH NODE PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PANCYTOPENIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    PETECHIAE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    SPLEEN DISORDER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    THROMBOTIC MICROANGIOPATHY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    THROMBOTIC THROMBOCYTOPENIC PURPURA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    5 / 302 (1.66%)
         occurrences all number
    1
    5
    BONE MARROW HYPOCELLULAR
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    EAR DISORDER PRESSURE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    EAR PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    2 / 302 (0.66%)
         occurrences all number
    3
    3
    EXTERNAL EAR INFLAMMATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    HEARING IMPAIRED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    MIDDLE EAR INFLAMMATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    TINNITUS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 302 (0.99%)
         occurrences all number
    0
    3
    VERTIGO
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    3 / 302 (0.99%)
         occurrences all number
    5
    3
    Eye disorders
    DRY EYE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    5 / 302 (1.66%)
         occurrences all number
    2
    5
    BLEEDING LEFT EYE AND EXOPHTHALMOS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    BLURRED VISION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    4 / 302 (1.32%)
         occurrences all number
    4
    4
    COLOUR VISION DISORDER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    CONJUNCTIVITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    7 / 298 (2.35%)
    2 / 302 (0.66%)
         occurrences all number
    7
    3
    CORNEAL ULCER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    DIPLOPIA OR DOUBLE PICTURES
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    EYE DISORDERS; CHALAZION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    EYE PRESSURE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    EYELID FUNCTION DISORDER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    FLASHING LIGHTS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    GLAUCOMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    RETINAL VASCULAR DISORDER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    2 / 302 (0.66%)
         occurrences all number
    2
    2
    UVEITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    VITREOUS HEMORRHAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    EYE PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    DRY MOUTH
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    ABDOMINAL DISTENSION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    ABDOMINAL PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    23 / 298 (7.72%)
    14 / 302 (4.64%)
         occurrences all number
    26
    16
    ANAL FISTULA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 302 (0.99%)
         occurrences all number
    1
    3
    ANAL HEMORRHAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    3 / 302 (0.99%)
         occurrences all number
    2
    3
    ANAL PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    4 / 302 (1.32%)
         occurrences all number
    0
    6
    ANAL ULCER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    4 / 302 (1.32%)
         occurrences all number
    0
    4
    ASCITES
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    BLOATING
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    CHEILITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    COLITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    9 / 298 (3.02%)
    2 / 302 (0.66%)
         occurrences all number
    9
    3
    COLONIC STENOSIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    CONSTIPATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    51 / 298 (17.11%)
    46 / 302 (15.23%)
         occurrences all number
    57
    54
    DIARRHEA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    168 / 298 (56.38%)
    64 / 302 (21.19%)
         occurrences all number
    238
    90
    DISCOLORATION OF THE TONGUE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    DIVERTICULA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    DUODENAL ULCER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    ORAL HEMORRHAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    3 / 302 (0.99%)
         occurrences all number
    3
    5
    DYSPHAGIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    ENTEROCOLITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    10 / 298 (3.36%)
    0 / 302 (0.00%)
         occurrences all number
    10
    0
    ESOPHAGEAL PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    ESOPHAGEAL ULCER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    ESOPHAGITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    FLATULENCE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    GASTRIC HEMORRHAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 302 (0.00%)
         occurrences all number
    3
    0
    GASTRIC MUCOSITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    GASTRIC ULCER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    GASTRITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    GASTROESOPHAGEAL REFLUX DISEASE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    7 / 298 (2.35%)
    3 / 302 (0.99%)
         occurrences all number
    8
    4
    GASTROINTESTINAL PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    5 / 302 (1.66%)
         occurrences all number
    2
    5
    GINGIVAL PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences all number
    1
    2
    HEMORRHOIDAL HEMORRHAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    HEMORRHOIDS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    8 / 298 (2.68%)
    13 / 302 (4.30%)
         occurrences all number
    8
    13
    ILEUS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    INGUINAL HERNIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    LOSS OF DENTAL CROWN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    LOWER GASTROINTESTINAL HEMORRHAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    MUCOSITIS NOS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    MUCOSITIS ORAL
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    102 / 298 (34.23%)
    41 / 302 (13.58%)
         occurrences all number
    127
    51
    NAUSEA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    106 / 298 (35.57%)
    55 / 302 (18.21%)
         occurrences all number
    158
    75
    DYSPEPSIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    7 / 298 (2.35%)
    7 / 302 (2.32%)
         occurrences all number
    10
    7
    ORAL PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 302 (0.99%)
         occurrences all number
    1
    3
    PERIODONTAL DISEASE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    8 / 302 (2.65%)
         occurrences all number
    1
    9
    PROCTITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    RECTAL FISTULA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    2
    RECTAL HEMORRHAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences all number
    3
    0
    RECTAL PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    SALIVARY DUCT INFLAMMATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    SIALORRHOEA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    SMALL INTESTINAL MUCOSITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    14 / 298 (4.70%)
    4 / 302 (1.32%)
         occurrences all number
    20
    4
    STOMACH PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    11 / 298 (3.69%)
    5 / 302 (1.66%)
         occurrences all number
    12
    5
    TOOTH DAMAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    TOOTHACHE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    2 / 302 (0.66%)
         occurrences all number
    2
    2
    TYPHLITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences all number
    3
    0
    UPPER GASTROINTESTINAL HEMORRHAGE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 302 (0.33%)
         occurrences all number
    2
    1
    VOMITING
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    42 / 298 (14.09%)
    22 / 302 (7.28%)
         occurrences all number
    61
    26
    PAIN SWALLOWING
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    CHOLECYSTITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences all number
    3
    0
    HEPATIC INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    HEPATITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    HEPATITIS VIRAL
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    HEPATOMEGALY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    INGUINALE PUSTULE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    10 / 298 (3.36%)
    1 / 302 (0.33%)
         occurrences all number
    13
    1
    HYPERHIDROSIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    FOLLICULITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    FISSURA ANI
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    EXANTHEMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences all number
    4
    0
    ERYTHRODERMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    2 / 302 (0.66%)
         occurrences all number
    5
    2
    ERYTHEMA SKIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    ERYTHEMA MULTIFORME
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    10 / 298 (3.36%)
    3 / 302 (0.99%)
         occurrences all number
    16
    3
    ERYTHEMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    ECZEMA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    DRY SKIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    1 / 302 (0.33%)
         occurrences all number
    5
    1
    CUTANEOUS NODULES
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    CELLULITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 302 (0.99%)
         occurrences all number
    1
    3
    BULLOUS DERMATITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 302 (0.99%)
         occurrences all number
    1
    4
    ALOPECIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    1 / 302 (0.33%)
         occurrences all number
    5
    1
    INFLAMMATION OF THE SWEAT GLANDS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    PETECHIAE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PHYMOSIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    PRURITUS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    13 / 298 (4.36%)
    5 / 302 (1.66%)
         occurrences all number
    15
    5
    PURPURA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    10 / 298 (3.36%)
    9 / 302 (2.98%)
         occurrences all number
    11
    12
    RASH
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    3 / 302 (0.99%)
         occurrences all number
    5
    3
    RASH ACNEIFORM
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    1 / 302 (0.33%)
         occurrences all number
    3
    1
    RASH MACULO-PAPULAR
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    77 / 298 (25.84%)
    30 / 302 (9.93%)
         occurrences all number
    104
    34
    SKIN INDURATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    SKIN LESIONS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    SKIN ULCERATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    4 / 302 (1.32%)
         occurrences all number
    2
    5
    STASIS DERMATITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    URTICARIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    1 / 302 (0.33%)
         occurrences all number
    3
    1
    VERRUCA SEBORRHOICA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    URINARY URGENCY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    URINARY TRACT PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    2 / 302 (0.66%)
         occurrences all number
    2
    2
    URINARY RETENTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    8 / 298 (2.68%)
    4 / 302 (1.32%)
         occurrences all number
    10
    5
    URINARY INCONTINENCE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    2 / 302 (0.66%)
         occurrences all number
    4
    2
    URINARY FREQUENCY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    5 / 302 (1.66%)
         occurrences all number
    0
    6
    RENAL INSUFFICIENCY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    RENAL COLIC
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    RENAL CALCULI
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    HEMATURIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    2 / 302 (0.66%)
         occurrences all number
    6
    2
    CYSTITIS NONINFECTIVE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    4 / 302 (1.32%)
         occurrences all number
    2
    4
    CHRONIC KIDNEY DISEASE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    ACUTE KIDNEY INJURY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    9 / 298 (3.02%)
    6 / 302 (1.99%)
         occurrences all number
    9
    7
    Endocrine disorders
    HYPERPARATHYROIDISM
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    INCREASE OF CORTISOLURIA - HYPERPLASIA (LEFT SURRENAL)
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    OSTEOPOROSIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    PAIN (LEGS)
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PAIN IN EXTREMITY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    3 / 302 (0.99%)
         occurrences all number
    6
    3
    ARTHRALGIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    10 / 302 (3.31%)
         occurrences all number
    3
    11
    ARTHRITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    6 / 302 (1.99%)
         occurrences all number
    2
    6
    BACK PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    9 / 298 (3.02%)
    10 / 302 (3.31%)
         occurrences all number
    11
    13
    BONE PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    9 / 302 (2.98%)
         occurrences all number
    4
    12
    CHEST WALL PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences all number
    4
    0
    DROP FOOT
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    DUPUYTREN DISEASE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    FLANK PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    2
    GENERALIZED MUSCLE WEAKNESS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    JOINT EFFUSION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    JOINT RANGE OF MOTION DECREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    MUSCLE WEAKNESS LOWER LIMB
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 302 (0.99%)
         occurrences all number
    0
    4
    MYALGIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    7 / 298 (2.35%)
    12 / 302 (3.97%)
         occurrences all number
    7
    12
    MYOSITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    NECK PAIN
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 302 (0.99%)
         occurrences all number
    0
    3
    Infections and infestations
    INFECTION (FOCUS UNKNOWN)
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    ABDOMINAL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    0 / 302 (0.00%)
         occurrences all number
    5
    0
    ANGIO INVASIVE ASPERGILLOSIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    ANORECTAL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    2 / 302 (0.66%)
         occurrences all number
    4
    2
    BACTEREMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    33 / 298 (11.07%)
    16 / 302 (5.30%)
         occurrences all number
    38
    17
    BLADDER INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    BRONCHIAL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    7 / 302 (2.32%)
         occurrences all number
    6
    7
    CATHETER RELATED INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    45 / 298 (15.10%)
    15 / 302 (4.97%)
         occurrences all number
    54
    15
    CHLAMYDIA PNEUMONIAE INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    CMV REACTIVATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    2 / 302 (0.66%)
         occurrences all number
    4
    4
    COVID-19 INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    DEVICE RELATED INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    ENTEROCOCCUS FAECALIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    ENTEROCOLITIS INFECTIOUS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    8 / 298 (2.68%)
    3 / 302 (0.99%)
         occurrences all number
    9
    3
    ESOPHAGEAL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    EYE INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    2 / 302 (0.66%)
         occurrences all number
    3
    2
    FUNGEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    GENERAL FUNGAL INFECTION (NO SEPSIS)
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    GUM INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         occurrences all number
    1
    2
    HERPES SIMPLEX VIRUS REACTIVATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    HHV6 INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    INFECTION ASPERGILLOSIS ON BAL
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    PLEURAL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    INFECTION DUE TO NEUTROPENIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    INFECTION ENTEROCOCCO VANCOMIMICINE RESISTANT (VRE)
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    INFECTION OTHER- GENERAL WITHOUT FOCUS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    INFECTION: OTHER: ACINETOBACTER
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    INFLUENZA, TYPE A
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    INVASIVE ASPERGILLOSIS PULMONAS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    JOINT INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    KIDNEY INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    LARYNGITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    LIP INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    15 / 298 (5.03%)
    17 / 302 (5.63%)
         occurrences all number
    15
    18
    LUNG INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    62 / 298 (20.81%)
    50 / 302 (16.56%)
         occurrences all number
    69
    58
    LYMPH GLAND INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    3 / 302 (0.99%)
         occurrences all number
    2
    3
    MUCOSAL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    13 / 298 (4.36%)
    12 / 302 (3.97%)
         occurrences all number
    17
    13
    NAIL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    OTHER: HERPES
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    OTITIS EXTERNA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    PAPULOPUSTULAR RASH
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    11 / 298 (3.69%)
    2 / 302 (0.66%)
         occurrences all number
    13
    2
    PARAINFLUENZA (NO SPECIFIC CLINICAL SITE OF INFECTION)
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    PARONYCHIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    PENILE INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    3 / 302 (0.99%)
         occurrences all number
    2
    3
    PHARYNGITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    3 / 302 (0.99%)
         occurrences all number
    3
    3
    PHLEBITIS INFECTIVE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    2 / 302 (0.66%)
         occurrences all number
    2
    2
    INFECTION CMV
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    PROSTATE INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    RASH PUSTULAR
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    4 / 298 (1.34%)
    4 / 302 (1.32%)
         occurrences all number
    5
    4
    RHINITIS INFECTIVE
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 302 (0.99%)
         occurrences all number
    0
    3
    SEPSIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    21 / 298 (7.05%)
    9 / 302 (2.98%)
         occurrences all number
    25
    13
    SEPTIC SHOCK
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    SINUSITIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    5 / 302 (1.66%)
         occurrences all number
    1
    5
    SKIN INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    17 / 298 (5.70%)
    16 / 302 (5.30%)
         occurrences all number
    20
    16
    SMALL INTESTINE INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences all number
    3
    0
    SOFT TISSUE INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 302 (0.99%)
         occurrences all number
    1
    3
    SYSTEMIC VIRAL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    TOOTH INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    6 / 302 (1.99%)
         occurrences all number
    3
    6
    UPPER RESPIRATORY INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    10 / 298 (3.36%)
    12 / 302 (3.97%)
         occurrences all number
    10
    15
    URETHRAL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    3
    0
    URINARY TRACT INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    16 / 298 (5.37%)
    15 / 302 (4.97%)
         occurrences all number
    19
    18
    VAGINAL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    VIREMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    VULVAL INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    WOUND INFECTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    HYPOMAGNESEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    5 / 302 (1.66%)
         occurrences all number
    10
    6
    VITAMIN B12 DEFICIENCY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    HYPOCALCEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    6 / 298 (2.01%)
    6 / 302 (1.99%)
         occurrences all number
    6
    7
    HYPOALBUMINEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    7 / 302 (2.32%)
         occurrences all number
    5
    10
    HYPERURICEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    6 / 298 (2.01%)
    4 / 302 (1.32%)
         occurrences all number
    8
    5
    HYPERNATREMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 302 (0.00%)
         occurrences all number
    3
    0
    HYPERMAGNESEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    HYPERKALEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    2 / 298 (0.67%)
    8 / 302 (2.65%)
         occurrences all number
    2
    9
    HYPERGLYCEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    9 / 298 (3.02%)
    2 / 302 (0.66%)
         occurrences all number
    10
    2
    FLUID RETENTION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences all number
    1
    0
    DEHYDRATION
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 302 (0.66%)
         occurrences all number
    0
    2
    CHLORIDE INCREASED
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    B12 AND FOLIC ACID DEFICIENCY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1
    ANOREXIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    39 / 298 (13.09%)
    25 / 302 (8.28%)
         occurrences all number
    48
    32
    ALKALOSIS
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 302 (0.33%)
         occurrences all number
    1
    1
    TUMOR LYSIS SYNDROME
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    3 / 298 (1.01%)
    1 / 302 (0.33%)
         occurrences all number
    3
    1
    HYPOPHOSPHATEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    5 / 298 (1.68%)
    5 / 302 (1.66%)
         occurrences all number
    6
    6
    HYPONATREMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    18 / 298 (6.04%)
    8 / 302 (2.65%)
         occurrences all number
    37
    14
    HYPOKALEMIA
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    46 / 298 (15.44%)
    39 / 302 (12.91%)
         occurrences all number
    74
    69
    VITAMIN D DEFICIENCY
    alternative dictionary used: CTCAE 4
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The futility analysis indicated futility. However, the IDMC recommended the study to continue as planned taking into account the risk-benefit for the patients. Since futility had already been concluded, the final analysis was descriptive.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37914482
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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