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    Clinical Trial Results:
    Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgery

    Summary
    EudraCT number
    		 2004-001810-16
    Trial protocol
    		 DE   DK   GB   ES   BE   IT  
    Global end of trial date
    12 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Apr 2018
    First version publication date
    15 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    62024
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00103168
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    EORTC HQ
    Sponsor organisation address
    Avenue Emmanuel Mounier 83, Brussels, Belgium, 1200
    Public contact
    Project, Budget and Regulatory Depa, European Organisation for Research and Treatment of Cancer, +32 27741044, regulatory@eortc.be
    Scientific contact
    Project, Budget and Regulatory Depa, European Organisation for Research and Treatment of Cancer, +32 27741044, regulatory@eortc.be
    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
    12 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether Imatinib mesylate, as an adjunct to complete surgery, is able to improve prognosis of patients with intermediate and high-risk, localized GIST.
    Protection of trial subjects
    - Prophylactic use of loperamide (e.g., Imodium®) is recommended for patients experiencing Grade 1 or 2 diarrhea. - Low-molecular weight heparin (Coumadin 1 mg QD) is permitted for prophylaxis of central venous catheter thrombosis, at the discretion of the treating physician.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 80
    Country: Number of subjects enrolled
    United Kingdom: 84
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    France: 266
    Country: Number of subjects enrolled
    Germany: 126
    Country: Number of subjects enrolled
    Italy: 127
    Country: Number of subjects enrolled
    Australia: 67
    Country: Number of subjects enrolled
    Netherlands: 63
    Country: Number of subjects enrolled
    New Zealand: 7
    Country: Number of subjects enrolled
    Poland: 60
    Country: Number of subjects enrolled
    Singapore: 7
    Worldwide total number of subjects
    908
    EEA total number of subjects
    827
    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)
    604
    From 65 to 84 years
    302
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: between 06/01/2005 and 15/10/2008. territories: 12 countries (9 EU countries and 3 non EU)

    Pre-assignment
    Screening details
    		 - Histologically proven diagnosis of GIST, with positive immunostaining for KIT (CD117), documented by polyclonal DAKO antibody staining. - Risk of relapse documented on the surgical specimen as falling within the “high-risk” category or the “intermediate-risk” category. - Surgery performed from 2 weeks to 3 months before randomization

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Observation
    Arm description
    		 Follow-up after surgery without further antitumoral therapy
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Imatinib mesylate
    Arm description
    		 Imatinib mesylate (400mg/day) during 2 years after surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imatinib mesylate
    Investigational medicinal product code
    NSC-716051
    Other name
    STI-571 , Gleevec, Glivec
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    400mg/day during 2 years

    Number of subjects in period 1
    		Observation Imatinib mesylate
    Started
    454
    454
    Completed
    454
    454
    Period 2
    Period 2 title
    On-study
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Observation
    Arm description
    		 Follow-up after surgery without further antitumoral therapy
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Imatinib mesylate
    Arm description
    		 Imatinib mesylate (400mg/day) during 2 years after surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imatinib mesylate
    Investigational medicinal product code
    NSC-716051
    Other name
    STI-571 , Gleevec, Glivec
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    400mg/day during 2 years

    Number of subjects in period 2
    		Observation Imatinib mesylate
    Started
    454
    454
    Completed
    453
    336
    Not completed
    1
    118
         Consent withdrawn by subject
    -
    22
         Wrong diagnosis, second cancer, concurrent disease
    -
    15
         Adverse event, non-fatal
    -
    56
         Did not start the treatment
    -
    5
         Treated with Imatinib in another center
    1
    -
         Lack of efficacy
    -
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Observation
    Reporting group description
    		 Follow-up after surgery without further antitumoral therapy

    Reporting group title
    Imatinib mesylate
    Reporting group description
    		 Imatinib mesylate (400mg/day) during 2 years after surgery

    Reporting group values
    		 Observation Imatinib mesylate Total
    Number of subjects
    		 454 454 908
    Age categorical
    Age in 4 categories
    Units: Subjects
        <= 20 years
    		 1 3 4
        21-40 years
    		 29 52 81
        41-60 years
    		 223 189 412
        > 60 years
    		 201 210 411
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 58 (49 to 68) 59 (48 to 67) -
    Gender categorical
    Units: Subjects
        Female
    		 220 222 442
        Male
    		 234 232 466
    Performance status
    Units: Subjects
        PS=0
    		 380 399 779
        PS=1
    		 74 54 128
        PS=2
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Observation
    Reporting group description
    		 Follow-up after surgery without further antitumoral therapy

    Reporting group title
    Imatinib mesylate
    Reporting group description
    		 Imatinib mesylate (400mg/day) during 2 years after surgery
    Reporting group title
    Observation
    Reporting group description
    		 Follow-up after surgery without further antitumoral therapy

    Reporting group title
    Imatinib mesylate
    Reporting group description
    		 Imatinib mesylate (400mg/day) during 2 years after surgery

    Primary: imatinib monotherapy failure free survival (IFS)

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    End point title
    		 imatinib monotherapy failure free survival (IFS)
    End point description
    Imatinib monotherapy Failure free Survival (IFS) is measured from the date of randomization to the date of occurrence of any of the following events: 1)start of new systemic treatment 2)combination of imatinib with a new systemic treatment 3)death from any cause If none of these events has occurred, patients will be censored at the date of last follow-up or at the date of clinical cut-off whichever occurs the first.
    End point type
    Primary
    End point timeframe
    Follow-up will be performed every 3 months until 2 years from randomization have elapsed, then every 4 months until 5 years have elapsed, and thereafter at least annually, at the discretion of the responsible physician.
    End point values
    		 Observation Imatinib mesylate
    Number of subjects analysed
    454
    454
    Units: events
        Imatinib failure free
    348
    358
        Imatinib failure: start of new systemic treatment
    76
    66
        Imatinib failure: death without new systemic treat
    30
    30
    Attachments
    		 IFS - Adjusted
    IFS - Unadjusted (per protocol)
    Statistical analysis title
    		 Imatinib Failure free Survival (IFS - Adjusted)
    Statistical analysis description
    Survival analysis at 5 years and at 10 years
    Comparison groups
    Imatinib mesylate v Observation
    Number of subjects included in analysis
    908
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.307 [1]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.866
    Confidence interval
         level
    		 95.7%
         sides
    2-sided
         lower limit
    		 0.651
         upper limit
    		 1.152
    Notes
    [1] - Adjusted by the stratification factors at randomization (Risk category, Resection, Tumor site)
    Statistical analysis title
    		 Imatinib Failure free Survival (IFS - Unadjusted)
    Statistical analysis description
    Unadjusted analysis (by protocol)
    Comparison groups
    Observation v Imatinib mesylate
    Number of subjects included in analysis
    908
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.345
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95.7%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.16

    Secondary: Relapse free Survival

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    End point title
    		 Relapse free Survival
    End point description
    Relapse free interval is measured from the date of randomization to the date of relapse. Patients alive and relapse free are censored at the date of last follow-up or at the date of clinical cut-off whichever occurs the first.
    End point type
    Secondary
    End point timeframe
    The same timeframe than the one used for primary endpoint
    End point values
    		 Observation Imatinib mesylate
    Number of subjects analysed
    454
    454
    Units: Events
        No relapse
    283
    299
        Relapse or death
    171
    155
    Attachments
    		 RFS - Adjusted
    Statistical analysis title
    		 Relaspe free survival (RFS - Adjusted)
    Statistical analysis description
    Adjusted for stratification factors (Risk category, Resection, Tumor Site)
    Comparison groups
    Imatinib mesylate v Observation
    Number of subjects included in analysis
    908
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.713
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.573
         upper limit
    		 0.887
    Statistical analysis title
    		 Relapse free Survival (RFS - Unadjusted)
    Statistical analysis description
    As prescribed per protocol
    Comparison groups
    Observation v Imatinib mesylate
    Number of subjects included in analysis
    908
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 0.95

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival is measured from the date of randomization to the date of death, whatever the cause. Alive patients are censored at the date of last follow-up or at the date of clinical cut-off whichever occurs the first.
    End point type
    Secondary
    End point timeframe
    The same than the one used for the primary endpoint
    End point values
    		 Observation Imatinib mesylate
    Number of subjects analysed
    454
    454
    Units: Events
        Alive
    285
    296
        Lost to follow-up
    86
    83
        Death
    83
    75
    Attachments
    		 OS - adjusted
    Statistical analysis title
    		 Overall survival (OS - Adjusted)
    Statistical analysis description
    Adjusted for stratification factors (Risk Category, Resection, Tumor Site)
    Comparison groups
    Observation v Imatinib mesylate
    Number of subjects included in analysis
    908
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.429
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.882
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.645
         upper limit
    		 1.205
    Statistical analysis title
    		 Overall Survival (OS - Unadjusted)
    Statistical analysis description
    As prescribed in the protocol
    Comparison groups
    Observation v Imatinib mesylate
    Number of subjects included in analysis
    908
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.476
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.22

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected on a CRF to be submitted at pre-specified timepoint
    Adverse event reporting additional description
    CRF for AEs contains pre-specified items + additional boxes for all "other" AEs. (xx% AEs are reported as "other" and are not reported as not available from the list of SOC). AEs are evaluated using CTC grading, SAEs using MedDra. Non-SAEs has not been collected specifically, all AEs will be reported in non-SAE section.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Observation
    Reporting group description
    		 Observation

    Reporting group title
    Imatinib Mesylate
    Reporting group description
    		 Imatinib Mesylate

    Serious adverse events
    		 Observation Imatinib Mesylate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    41 / 454 (9.03%)
    84 / 454 (18.50%)
         number of deaths (all causes)
    83
    75
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BASAL CELL CARCINOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BENIGN OVARIAN TUMOUR
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRAIN NEOPLASM
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BREAST CANCER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHIAL CARCINOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC LYMPHOCYTIC LEUKAEMIA STAGE 0
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DESMOID TUMOUR
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENDOMETRIAL ADENOCARCINOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL STROMAL TUMOUR
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG NEOPLASM MALIGNANT
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    MALIGNANT MELANOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALIGNANT NEOPLASM PROGRESSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAPILLARY THYROID CANCER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PENILE CANCER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROSTATE CANCER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL CANCER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL CELL CARCINOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SCHWANNOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SQUAMOUS CELL CARCINOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TUMOUR HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UTERINE LEIOMYOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOVOLAEMIC SHOCK
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VARICOSE VEIN
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    CORONARY ARTERY BYPASS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXPLORATIVE LAPAROTOMY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RADIOACTIVE IODINE THERAPY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SURGERY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CHEST PAIN
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DISEASE RECURRENCE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FATIGUE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MULTI-ORGAN FAILURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 454 (0.44%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    NODULE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OEDEMA PERIPHERAL
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYREXIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    ENDOMETRIOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENITAL HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VAGINAL PROLAPSE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY FAILURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPNOEA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG DISORDER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURAL EFFUSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY FIBROSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY DISTRESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    DEPRESSED MOOD
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEPRESSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MAJOR DEPRESSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASPARTATE AMINOTRANSFERASE INCREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGOGASTRODUODENOSCOPY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (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
    FEMUR FRACTURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POSTOPERATIVE ADHESION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOXICITY TO VARIOUS AGENTS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ANGINA UNSTABLE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FLUTTER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE ACUTE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCARDIAL INFARCTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCARDIAL ISCHAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SICK SINUS SYNDROME
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    CEREBRAL HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    CEREBRAL ISCHAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CUBITAL TUNNEL SYNDROME
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEADACHE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PARTIAL SEIZURES
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBARACHNOID HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIITH NERVE PARALYSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LYMPHADENOPATHY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    VESTIBULAR DISORDER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    ORBITAL OEDEMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL ADHESIONS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 454 (0.66%)
    8 / 454 (1.76%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL DISTENSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FLATULENCE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRIC ULCER PERFORATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    HERNIAL EVENTRATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    4 / 454 (0.88%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INGUINAL HERNIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILEUS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL OBSTRUCTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 454 (0.66%)
    3 / 454 (0.66%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARGE INTESTINAL OBSTRUCTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MELAENA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NAUSEA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGEAL PERFORATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS ACUTE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS NECROTISING
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS RELAPSING
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RECTAL HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 454 (0.44%)
    2 / 454 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBILEUS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLELITHIASIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATITIS TOXIC
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATOCELLULAR INJURY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JAUNDICE CHOLESTATIC
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    ERYTHEMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTROPHIC SCAR
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    RENAL COLIC
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 454 (0.44%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL FAILURE ACUTE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL FAILURE CHRONIC
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    GOITRE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOXIC NODULAR GOITRE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    ABDOMINAL ABSCESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABSCESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    APPENDICITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ERYSIPELAS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERPES ZOSTER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OTITIS EXTERNA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PELVIC ABSCESS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN CANDIDA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STAPHYLOCOCCAL SEPSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DIABETES MELLITUS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERGLYCAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOGLYCAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOKALAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPONATRAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALNUTRITION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Observation Imatinib Mesylate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    205 / 454 (45.15%)
    442 / 454 (97.36%)
    Vascular disorders
    COLD FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COLD FINGERS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COLD HAND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    COLD HAND, FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COLD HAND/FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COLD HANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    7
    COLD HANDS AND FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ORAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PHLEBITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    POOR CIRCULATION FINGERTIPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    6
    POOR CIRCULATION IN FINGERTIPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    POOR CIRCULATION OEDEMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RAYNAUD'S LIKE SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    REYNAUD'S LIKE SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    REYNAUD'S-LIKE SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SENSATION OF HEAVY LEGS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SEVERE BRUSING LEFT ARM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    THROMBOSIS VENA MESENTERICA & PORTA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    VASCULAR FRAGILITY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VASCULARY WEAKNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VENOUS INSUFFICIENCY IN MEMBERS INFERIORS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    ABDOMEN NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ABDOMINAL SCAR CALCIFICATION SURGERY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ABDOMINAL WALL RECONSTRUCTION BECAUSE OF LAPAROCELE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ANUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    APPENDECTOMY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    BLADDER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BONE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    BRAIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BREAST
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    BRONCHUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COLON
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CONJUNCTIVA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EXCISION OF PAPILLARY CARCINOMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EYE NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ILEUM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    JEJUNOSTOMY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    JOINT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    KIDNEY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    LAPAROTOMY EVENTRATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    5
    0
    LIVER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LUNG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MUSCLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NAILS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NASAL CAVITY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NOSE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ORAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    OTHER SURGICAL AND MEDICAL PROCEDURES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PHARYNX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PROSTATE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PLEURA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    RECTUM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    REN SURGERY FOR RENAL CELL CARCINOMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SALIVARY GLAND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SINUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SKIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SMALL BOWEL NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    STOMACH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SPLEEN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SURGERY FOR METASTASIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    TEETH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TENDON
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TONGUE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    THYROID
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TRACHEA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    UPPER AIRWAY NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    URETHRA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    URINARY TRACT NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    UTERUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VAGINA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    VULVA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    ABDOMEN NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    19 / 454 (4.19%)
    46 / 454 (10.13%)
         occurrences all number
    32
    100
    AGRESSIVENESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    AGGRESSIVENESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ASTHENIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CHILLS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    12 / 454 (2.64%)
         occurrences all number
    0
    31
    CHILLY FEELING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COLD FEELING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COLD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    8 / 454 (1.76%)
         occurrences all number
    0
    10
    COMMON COLD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    4
    CONJONCTIVAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    DULLED AFTER TAKING DRUG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DUMPING SYNDROM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DUMPING SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    6
    FACE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FATIGUE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    55 / 454 (12.11%)
    272 / 454 (59.91%)
         occurrences all number
    112
    1236
    FEELS ASTHENIC, LETHARGIC AFTER TAKING DRUG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FEELS COLD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FEELS HANGOVER AFTER TAKING DRUG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FEVER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    16 / 454 (3.52%)
         occurrences all number
    1
    22
    FEVER (OCCASIONAL)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FEVER 38°
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FEVER 39°C
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FLU
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FLU LIKE SYMPTOMS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    FLU LIKE SYNDROM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FLU LIKE SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    FLU SYMPTOMS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FLU SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FLU-LIKE SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    7 / 454 (1.54%)
         occurrences all number
    0
    7
    FLUSHES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    3 / 454 (0.66%)
         occurrences all number
    1
    3
    FREEZING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GAIN WEIGHT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GRIPPAL SYNDROM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HEAD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INSOMNIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    26 / 454 (5.73%)
         occurrences all number
    3
    67
    LETHARGY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LOSS OF BODY WEIGHT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MALAISE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MALAISE WITHOUT CONSCIOUSNESS LOSS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MUSCLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NIGHT SWEAT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    NIGHT SWEATS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    OTHER GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PAIN NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PELVIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    PELVIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    1 / 454 (0.22%)
         occurrences all number
    3
    1
    REDUCE PHYSICAL POWER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RENAL TUMOR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RIGORS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    12
    RIGORS CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RIGORS, CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RIGORS/CHILLS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    8 / 454 (1.76%)
         occurrences all number
    0
    23
    SHIVERS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    4
    SICKNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SLEEP DISORDER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    3
    0
    SLEEP DISTURBANCE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SLEEPING DISORDER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SWEAT (NIGHT)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SWEAT(NIGHT)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SWEATING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    6 / 454 (1.32%)
         occurrences all number
    6
    8
    SWEATS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VITAMIN DEFICIENCY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    WEAKNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    4
    WEIGHT GAIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    WEIGHT GAIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    7 / 454 (1.54%)
    175 / 454 (38.55%)
         occurrences all number
    10
    508
    WIEGHT GAIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    Immune system disorders
    ALLERGIC RHINITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ALLERGY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    IODINE ALLERGY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    12
    RHINITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    CONISATION ON INTRAEPITHELIAL LESIONS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DYSMENORRHOEA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EJACULATORY DYSFUNCTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ENDOMETRIOSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    ERECTILE DYSFUNCTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    5
    ERECTILE IMPOTENCE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    3
    0
    GYNECOMASTIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GYNECOMASTY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYPERMENORRHEA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYPERMENORRHOEA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYSTERECTOMY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    IMPOTENCE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    2
    1
    MENORRHAGIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    MENSES UNREGULARLY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PRIAPISM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    TESTICLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    UNREGULARLY MENSES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    URETHRA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    VAGINA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    VAGINAL MUCOSITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VAGINITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY INSUFICIENCY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ASTHMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    2
    BILATERAL PULMONARY INFILTRATES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BRONCHITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    BRONCHUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CATARRH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    CHEST/THORAX NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    2 / 454 (0.44%)
         occurrences all number
    2
    2
    COLD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    3
    COLD SYMPTOMS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COMMON COLD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    COPD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    COUGH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    28 / 454 (6.17%)
         occurrences all number
    4
    50
    DEEP VOICES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DYSPHONIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    3
    DYSPNEA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    6 / 454 (1.32%)
    37 / 454 (8.15%)
         occurrences all number
    9
    96
    FEW BASAL CREPS + RONCHI
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    FLU
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HEAD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HOARSE VOICE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    3
    HOARSENESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    INTERSTITIAL PNEUMOPATHY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    LUNG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NASAL CONGESTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NASAL OBSTRUCTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    ORAL CAVITY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PARANASAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    PHARYNGITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PHARYNX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PLEURA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    PNEUMONIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PNEUMONITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PNEUMOPATHY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    POLLENOSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PULMONARY EMPHYSEME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PULMONITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    RESPIRATORY DISTRESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SINUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SORE THROAT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    THORAX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    THROAT IRRITATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TONSILITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TRACHEA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TRACHEITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    URTI
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VOICE CHANGES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VOICE CHANGES (HOARSENESS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    WHEEZING (EXPIRATORY WHEEZING)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    Investigations
    WEIGHT LOSS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    7 / 454 (1.54%)
    64 / 454 (14.10%)
         occurrences all number
    9
    153
    Cardiac disorders
    ATRIAL FLUTTER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    CARDIAC (GENERAL)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    21 / 454 (4.63%)
    38 / 454 (8.37%)
         occurrences all number
    32
    79
    PALPITATIONS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PERICADIAL EFFUSION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PERICARDIAL EFFUSION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    PLEURA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SICK SINUS SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SINUS BRADYCARDIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    Nervous system disorders
    ACOUSTIC NEUROMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    AGITATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    ANXIETY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    5 / 454 (1.10%)
    11 / 454 (2.42%)
         occurrences all number
    6
    24
    ARMS : TINGLING/NUMBNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BUTTOCK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BUZZING IN THE EARS (RIGHT)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CARPAL TUNNEL SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    CNS CEREBROVASCULAR ISCHEMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COENCENTRATION DIFFICULTY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    COGNITIVE DISTURBANCE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    3 / 454 (0.66%)
         occurrences all number
    3
    3
    CONCENTRATION ALTERATION (DIFFICULTY)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    18
    CRAMPS + SMARTING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS LEG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS LOWER LIMB
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    CUBITAL TUNNEL SYNDROM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DECLINED SIGHT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DEPRESSION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    6 / 454 (1.32%)
    18 / 454 (3.96%)
         occurrences all number
    13
    39
    DIFFICULTY WITH SHORT TERM MEMORY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DIZZINES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    DIZZINESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    3 / 454 (0.66%)
    32 / 454 (7.05%)
         occurrences all number
    5
    57
    DIZZY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DIZZY SPELL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DIZZYNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EYE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FACIAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    10
    FAINTING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FORGETFULNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HEAD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INSOMNIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    8
    IRASCIBLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LACK OF CONCENTRATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LEFT LIMB PARESTHESIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LEG CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MEMORY IMPAIRMENT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    2 / 454 (0.44%)
         occurrences all number
    1
    2
    MEMORY INPAIRMENT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MIGRAINES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MOOD ALTERATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    4 / 454 (0.88%)
         occurrences all number
    1
    6
    MUSCLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    8
    MOOD ALTERATION-DEPRSSION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NEUROPATHY CRAMP HANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NEUROPATHY SENSORY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    5
    NECK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    NEUROPATHY- SENSORY (FORMICATION IN HANDS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NEUROPATHY: CRAMP HANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    8
    NEUROPATHY: CRANIAL - CN I SMELL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NEUROPATHY: CRANIAL : CN V
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NEUROPATHY: CRANIAL -CN I SMELL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NEUROPATHY: CRANIAL: CN V
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NEUROPATHY:SENSORY (PARAESTHESIAS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NEUROPATHY-SENSORY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    NEUROPATHY-SENSORY (PARESTHESIA HANDS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NUMB FINGERS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NUMBNESS OF LEFT THIGH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    NUMBNESS AROUND OPERATION SITE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NUMBNESS-COLATERAL HAND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OBNUBILATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    5
    OTH DISC DEGENERATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PARAESTHESIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PARASHESIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PARASTHESIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    5
    PARASTHESIAS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PARESTHESIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    PARESTHESIAS ON HANDS AND FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PARESTHESIE FOOT BILATERAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PERIPHERAL POLYNEURITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PINS+NEEDLE SENSATION DOWN LEG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    POOR CIRCULATION FINGER TIPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    POLYNEUROPATHY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    POOR CONCENTRATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    POOR CONCENTRATION (ADD)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    R SCIATICA NERVE PAIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SEIZURE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    SENSITIVE DYESHESIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SENSORY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SENSORY NEUROPATHY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SENSORY NEUROPATHY (HANDS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    SENSORY NEUROPHATY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SEVERE NUMBNESS LEFT FOOT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SENSORY: LEFT UPPER LEG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SMARTING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    SLUMBER TROUBLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    SMELL LOSS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SOMNOLENCE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    3
    STIFFNESS FINGERS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    SYNCOPE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    TINGLING FINGERS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    TINGLING LEFT ARM + FINGERS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TRANSISCHEMIC ATTACK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TREMOR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    10
    TRENSION OF UPPER EXTREMITIES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    TWO LYPOTHYMIC EPISODES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VAGAL DISCONFORT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VERTIGO
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    4 / 454 (0.88%)
         occurrences all number
    1
    18
    WEEKNESS RIGHT LEG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    ABDOMINAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    5
    ANEMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    6 / 454 (1.32%)
         occurrences all number
    1
    17
    ANKLE SLIGHTY SWOLLEN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BLOCKED RIGHT EAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    EDEMA FINGERS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EDEMA LEGS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EDEMA VISCERA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    7 / 454 (1.54%)
         occurrences all number
    0
    11
    EDEMA, HEAD&NECK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    4 / 454 (0.88%)
    284 / 454 (62.56%)
         occurrences all number
    8
    1555
    EDEMA, LIMBS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    3 / 454 (0.66%)
    127 / 454 (27.97%)
         occurrences all number
    3
    386
    EDEMA, TRUNK/GENITAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    6
    EOSINOPHILIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    EXCESSIVE LACRIMATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    EYE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    3
    HEMATOMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    5 / 454 (1.10%)
         occurrences all number
    2
    7
    HEMOGLOBIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    IRON DEFICIENCY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    LEGS VENOUS FAILURE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LYMPH NODE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MESENTERIC PANNICULITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    NEUTROPENIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OEDEMA BUT LOCATION NOT RECORDED
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PALPABLE LYMPHNODE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PALPABLE LYMPHNODE SUBMANDIBULAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    RIGHT KNEE SWOLLEN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SIDEROPENIC ANAEMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SWOLLEN GLAND (SUBMANDIBULAR)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SWOLLEN GLANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    UNSPECIFIED OEDEMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    WATER RETENTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    AUDITORY/EAR -> BLOCKED EARS WITH MAX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DEAFNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    EAR NOISES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HEARING (ACOUSTIC PROBLEMS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYPOACUSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LEFT EAR RINGING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OTITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    TINNITUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    6
    VESTIBULAR FAILURE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    Eye disorders
    ALLERGICAL CONJUNCTIVITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BLEPHARITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BLURRED VISION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    7 / 454 (1.54%)
         occurrences all number
    1
    11
    BURN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CATARACT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CONJONCTIVITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    5
    CONJUNCTIVA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CONJUNCTIVITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    7 / 454 (1.54%)
         occurrences all number
    0
    23
    DECREASE OF VISUAL FUNCTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DECREASE VISUAL FUNCTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DIPLOPIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    DRY EYE SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    6
    DRY MUCOUS MEMBRANE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DRY MUCUOUS MEMBRANE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EYE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    22 / 454 (4.85%)
         occurrences all number
    0
    34
    GLAUCOMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    HYPEREMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    IMPAIRED VISION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ITCHING PERIORBITAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    LACRIMATION INCREASED
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    MACULAR DEGENERATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    NYSTAGMUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OCULAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OCULAR SURFACE DISEASE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    18 / 454 (3.96%)
         occurrences all number
    0
    33
    OPHTALMIC TROUBLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PHOTOPHOBIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TEARING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    6
    TEARING (+COPING PROBLEMS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VISION DISTURB
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VISUAL DISTURBANCE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VISUAL TROUBLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    WATERY EYE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    26 / 454 (5.73%)
         occurrences all number
    1
    84
    Gastrointestinal disorders
    ABDO PART, BLOATING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ABDOMEN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    20 / 454 (4.41%)
    29 / 454 (6.39%)
         occurrences all number
    38
    48
    ABDOMEN NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    ABDOMINAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    18 / 454 (3.96%)
    37 / 454 (8.15%)
         occurrences all number
    29
    65
    ABDOMINAL BLOATING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    2 / 454 (0.44%)
         occurrences all number
    1
    2
    ABDOMINAL COLIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    ABDOMINAL COLICS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ABDOMINAL CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ABDOMINAL CRAMPING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ABDOMINAL CRAMPING AFTER INTAKE OF IMATINIB
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ABDOMINAL CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    3 / 454 (0.66%)
         occurrences all number
    2
    3
    ABDOMINAL DISCONFORT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    3
    ABDOMINAL DISTENSION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    ABDOMINAL FULLNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ABDOMINAL HERNIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    ABDOMINAL HERNIA OF THE SCAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ABDOMINAL HERNIA SCAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    ABDOMINAL MASS STITCH ABCESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ABDOMINAL SCAR HERNIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    ABDOMINAL SENSITIVE TOUCH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ACID REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ACID REGURGITATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    ACIDITY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    ACUTE GASTROENTERITIS WITH AUTOLIMITED RECTAL BLEEDING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ADDED DEJECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ADENOMA OF THE SIGMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ADHESIONS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ANAL MUCOSITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ANUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    APHTOSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ASCITES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    BELCHING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    6
    BLACK STOOL (2X)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BLACK STOOLS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    BLOATED FEELING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    BLOATED FEELINGS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BLOATING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    3 / 454 (0.66%)
         occurrences all number
    1
    4
    BLOATING AND INDIGESTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    BORBORYGMUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BOWEL ADHESION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    BOWEL COMPLAINTS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    BOWEL OBSTRUCTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BUCCAL MUCOSITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BURN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    CHOLELITHIASIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COLIC POLYPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COLITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COLON
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CONSIPATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CONSITPATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CONSTIPATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    18 / 454 (3.96%)
    45 / 454 (9.91%)
         occurrences all number
    30
    110
    COPROSTASE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    COPROSTASIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DEFAECATION NOT REGULAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DEHYDRATATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DENTAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DENTAL/TEETH/PERIDONTAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    3
    DIARRHEA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    41 / 454 (9.03%)
    219 / 454 (48.24%)
         occurrences all number
    76
    874
    DIFFICULTY OF SWALLOWING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DIFFICULTY SWALLOWING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DIGESTIVE DISORDER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DISCONFORT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DISGUEUSIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DISPESIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DISTENSION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    4 / 454 (0.88%)
    3 / 454 (0.66%)
         occurrences all number
    4
    3
    DISTENSION/BLOATING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    0 / 454 (0.00%)
         occurrences all number
    3
    0
    DISTENSION/BLOATING, ABDOMINAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DISTENSTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DISTENTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DRY MONTH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DRY MOUNTH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    DRY MOUTH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    13 / 454 (2.86%)
         occurrences all number
    0
    29
    DRY THROAT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DUMPING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DUMPING SYNDROM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DUMPING SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DYSFAGIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DYSGEUSIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DYSPEPSIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    4 / 454 (0.88%)
    12 / 454 (2.64%)
         occurrences all number
    4
    19
    DYSPESIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DYSPHAGIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    7 / 454 (1.54%)
         occurrences all number
    1
    11
    DYSPHAGY (ANASTOMOSE)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EARLU SATIETY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EARLY SATIETY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    3 / 454 (0.66%)
         occurrences all number
    3
    7
    ENTERITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    EPIDGASTRIC HEAVINESSES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EPIGASTRALGIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    10 / 454 (2.20%)
         occurrences all number
    0
    19
    EPIGASTRALGY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    EPIGASTRIC BLOATING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    EPIGASTRIC DISCOMFORT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    2 / 454 (0.44%)
         occurrences all number
    2
    2
    EPIGASTRIC DISCONFORT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EPIGASTRIC TENDERNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    EPYGASTRALGY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ERUCTATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    2 / 454 (0.44%)
         occurrences all number
    4
    3
    ESOPHAGEAL REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    ESOPHAGITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    7 / 454 (1.54%)
         occurrences all number
    1
    16
    FAECAL PAIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    FEELING BLOATED
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    FEELING OF FULLNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    FISTULA COLO-CUTANEOUS PRESACRUM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    FISTULA COLO-CUTANEOUS PRE-SACRUM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    3
    0
    FLATULENCE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    10 / 454 (2.20%)
    12 / 454 (2.64%)
         occurrences all number
    12
    29
    FUSTULA IN THE ANASTOMOSUS OESOPHAGA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FUSTULA OF OESOPHAGEAL-JEJUNAL ANAST
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GALLSTONES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    GASTR- OESOPHAGEAL REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTRALGIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    10
    GASTRIC ACIDITY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    4
    GASTRIC DISCOMFORT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTRIC DISCONFORT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTRIC REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    4 / 454 (0.88%)
         occurrences all number
    1
    4
    GASTRIC TROUBLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    GASTRITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    4 / 454 (0.88%)
    10 / 454 (2.20%)
         occurrences all number
    4
    15
    GASTRO ENTERITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTRO ESOPHAGEAL REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTRO ESOPHAGIAL REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTRO OESOPHAGEAL REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTROENTERITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    7 / 454 (1.54%)
         occurrences all number
    0
    7
    GASTRO-ENTERITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTROENTRETIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTROESOPHOGAL REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTRO-INTESTINAL REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GASTRO-OESOPHAGAL REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    GERD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    4
    0
    GRAVITY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    GRELIC OCCLUSION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GUT CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    HEARTBURN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    10 / 454 (2.20%)
    29 / 454 (6.39%)
         occurrences all number
    12
    58
    HEARTBURN/DYSPEPSIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    HEMORRHOIDAL CONGESTION WITH UNCONTROLLED PAIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HEMORRHOIDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    HERNIE SCAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    HIATAL HERNIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    14
    ILEUM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ILEUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ILEUS (ADHESION)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INCISIONAL HERNIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INCREASE BELCHING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INCREASE OF APETITE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    INCREASED ABDOMINAL HERNIA SCAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    INCREASED APETITE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    INCREASED BOWEL OPENING 6-8 TIMES DAILY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INDIGESTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    8 / 454 (1.76%)
         occurrences all number
    3
    10
    INTERMITTENT GASTRIC REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INTESTINAL SUBOCCLUSION CRISIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INTESTINAL TRANSIT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INTOLERANCE ON FATTY FOODS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    IRREGULAR DEFECATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LACK OF APETITE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LEFT RECTUS ABDOMINIS NODULE ABLATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LOSS OF APETITE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LOSS OF APPETITE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    MALNUTRITION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MELAENA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    METEORISM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    4
    METEORISMUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    1 / 454 (0.22%)
         occurrences all number
    2
    1
    MOUTH ULCER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MUCOSA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MUCOSITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    8 / 454 (1.76%)
         occurrences all number
    1
    20
    MUSHY DEFECATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    NAUSEA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    25 / 454 (5.51%)
    198 / 454 (43.61%)
         occurrences all number
    33
    675
    OBSTIPATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    3 / 454 (0.66%)
    5 / 454 (1.10%)
         occurrences all number
    4
    6
    OESOPHAGEAL REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ORAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ORAL CAVITY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PANCREATITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    2 / 454 (0.44%)
         occurrences all number
    1
    2
    PASSAGE PROBLEMS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PERIANAL WARMTH POST GLIVEC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PHARYNX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PIROSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    POST PANDRIAL FULLNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    POOR APPETITE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    POSTPANDRIAL HEAVINESS AFTER TO TAKE IMATINIB
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    POUTH DRYNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PRESSURE EPIGASTRIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PRESURE EPIGASTRIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PYROSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    10 / 454 (2.20%)
         occurrences all number
    3
    21
    RCU
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RECTAL BLEEDING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    RECTAL INCONTINENCE (OCCASSIONAL)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    RECTUM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    2
    RECTAL TENESMUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    4
    REFLUX ( OCCASIONAL)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    REFLUX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    5 / 454 (1.10%)
         occurrences all number
    4
    9
    REFLUX GASTROOESOPHAGEAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RGO
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    8
    REGURGITATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    RUCTUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    2 / 454 (0.44%)
         occurrences all number
    3
    6
    SALIVARY GLAND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SLIGHT DYSPHAGY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SMALL BLISTER MOUTH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SMALL BOWEL NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SMALL HERNIA UMBILICALIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SORETHROAT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    STOMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    4 / 454 (0.88%)
         occurrences all number
    1
    5
    SUBILEUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    STOMACH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    4 / 454 (0.88%)
    19 / 454 (4.19%)
         occurrences all number
    6
    34
    TASTE ALTERATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    29 / 454 (6.39%)
         occurrences all number
    0
    68
    SUSPECTED GIST RECURRENCE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SUBOCCLUSION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    TEETH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    THIRST
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    THIRSTY SENSATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    6
    TONGUE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    6
    TOOTH DECAY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TRACHEA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TRANSIT-INTESTINAL GESTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ULCER OESPHAGUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VESICAL MUCOSITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VOMITING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    14 / 454 (3.08%)
    89 / 454 (19.60%)
         occurrences all number
    16
    138
    Hepatobiliary disorders
    BILIARY COLI
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HEPATIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LIVER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PANCREATITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TOXIC HEPATITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    5
    Skin and subcutaneous tissue disorders
    ACNE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    3
    ALOPECIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    31 / 454 (6.83%)
         occurrences all number
    2
    60
    AURICULAR ECZEMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BACK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BASOCELLULAR EPITHELIOMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BLISTER RIGHT ARM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BRUISING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    BUCCAL RHAGADES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    BURN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    3
    CHANGE IN HAIR COLOR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CHEILITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    CHELITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CONTACT DERMATITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CONTACT DERMATITIS ON HANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CUT RIGHT HAND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CUTANEOUS DRYNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    6 / 454 (1.32%)
         occurrences all number
    0
    6
    CUTANEOUS ERRUPTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CUTANEOUS ERUPTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    3
    CUTANEOUS REACTION TO IODE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DEPIGMENTATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DERMATITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DISCOMFORT FROM SCAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DRY HANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DRY LEGS+FEET/ATHLETES FOOT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DRY SKIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    4 / 454 (0.88%)
    32 / 454 (7.05%)
         occurrences all number
    4
    65
    DRY SKYN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    4
    DYSCHROMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    ECZEMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    6 / 454 (1.32%)
         occurrences all number
    0
    14
    ECZEMA ( ARMS/TOUTH)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ECZEMA (LOWER LIMBS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ECZEMA ON HAND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ECZEMA RIGHT HAND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ERYSIPELAS LEFT LEG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ERYSIPELOID LESION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ERYTHEMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    8 / 454 (1.76%)
         occurrences all number
    1
    23
    ERYTHEMA FINGERS HANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ERYTHEMA LESION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ERYTHEMA ON THE HANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ERYTHEMA PERIORBITAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ERYTHEMA WITH HYPERKERATOSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    5
    EXANTHEMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    5
    EXCOLIATION BELOW KNEE BOTH LEGS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EYE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    5 / 454 (1.10%)
         occurrences all number
    0
    12
    FACE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    12
    FACIAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FLUCHES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    FLUSHING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    2 / 454 (0.44%)
         occurrences all number
    3
    3
    FOLLICLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FOLLICULITE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    4
    FOLLICULITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FUNGAL RASH ON LEGS AND ARMS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    HAIR LOSS/ALOPECIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HAND +FOOT SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HAND REACTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HAND-FOOT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HANDS ECZEMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HERPES SIMPLEX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYPERPIGMENTATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    6
    HYPOPIGMENTATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    5 / 454 (1.10%)
         occurrences all number
    0
    15
    INFECTED INSECT BITE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    INFLAMED UMBILICUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    ITCHING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    5 / 454 (1.10%)
         occurrences all number
    0
    11
    ITCHING BOTH ARMS AND LEGS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ITCHING RIGHT KNEE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    KERATOSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    L ANKLE MACULOPAPULAR MARK IMPROVING
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LASH AND BROW LOSS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LASH LOSS, BROW LOSS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    LAT. UPPER L LEG ERYTEMA SCALY PLAQU
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LESION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LIP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    5
    MACULAR LESION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MACULOPAPULAR MASK ABOVE L ANKLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MULTIPLE KERATOACANTHOMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NAEVUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NAIL CHANGES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    3
    NAIL LOSS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NAILS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    NOT SPECIFIED
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    2
    1
    OCULAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ONYCHORRHEXIS (UNGUEAL TOXICITY)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OTH DERMATITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PAPILLOMATOUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    PERIORBITAL ERYTHEMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PHOTOSENSITIVITY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PRURIT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    PRURITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    13 / 454 (2.86%)
         occurrences all number
    1
    25
    PRURITIS LEGS AND ARMS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PRURITUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    14 / 454 (3.08%)
         occurrences all number
    2
    37
    PRUTITUS (INTERMITTENT PRURIT)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PSIORASIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PSIORIASIS VULGARIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PSORIASIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    3 / 454 (0.66%)
         occurrences all number
    3
    7
    PSORIASIS LIKE LESIONS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    PSORIASIS-LIKE LESIONS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PURITIS MEDIAL LEFT CALF
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RASH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    RASH (AXILLARY)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RASH RIGHT LEG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RECURRENT LESIONS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RIGORS/CHILLS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RING WORM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SCALP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    2 / 454 (0.44%)
         occurrences all number
    1
    2
    SCAR HERNIATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SEBORRHEIC KERATOSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SEBORRHEIC WART ERUPTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    SKALP KIST
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SKIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    12 / 454 (2.64%)
         occurrences all number
    0
    14
    SUN SENSITIVITY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SWELLING & THICKENING SUBCUTAN TISS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SWELLING THICKENING OF SUBCUTAN TISS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SWELLING&THICKENING OF SUBCUT. TISSU
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TELANGIECTASIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TRUNK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    ULCERATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    ULCER-POSSIBLE SPIDER BITE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    UNGUEAL TOXICITY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    WATER BLISTER (LOWER LEFT LEG)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    WOUND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    BLADDER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    12
    CHRONIC RENAL INSUFFICIENCY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    CHRONIC RENAL INSUFICIENCY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    COLITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CREATININ CLEARANCE DECREASE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CYSTITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    6
    DISURIA (URINARY PAIN)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DYSURIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    4
    FIBROID UTERINE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    HEMATURIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYDROCAELE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INCREASE OF PSA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    KIDNEY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    LOW URINE OUTPUT (LOW VOLUME)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LOWERING OF CREATININ CLEARANCE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OFFENSIVE SMELLING URINE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PELVIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    PERSITENT PV DISCHARGE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    POLLAKIURIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PROSTATE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PROSTATIC HYPERTROPHY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    PROSTATITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RENAL CHRONIC FAILURE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RENAL COLIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    4
    RENAL FAILURE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RENAL INSUFFICIENCY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    STOMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    URETHRA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    URINARY DIFFICULTY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    URINARY FREQUENCY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    4 / 454 (0.88%)
         occurrences all number
    1
    7
    URINARY FREQUENCY (NOCTURIA)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    URINARY INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    URINARY TRACT SYMPTOMS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    UTERUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VAGINA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    DIABETES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    DIABETES (SURGERY RELATED)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    FLUSHES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    1 / 454 (0.22%)
         occurrences all number
    2
    2
    HOT FLASHES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    5 / 454 (1.10%)
         occurrences all number
    0
    14
    HYPERTHYROIDISM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    THYROID
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    4
    Musculoskeletal and connective tissue disorders
    ABDOMEN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    ANKYLOSIS MAXILLA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    ARTHRITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    2 / 454 (0.44%)
         occurrences all number
    5
    2
    ARTHROSES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    ARTHROSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    0 / 454 (0.00%)
         occurrences all number
    10
    0
    BURSITIS SHOULDER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    BUTTOCK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    CALF CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    CALFS CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CERVICAL CONTRACTURE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    9
    CRAMP (HANDS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMP IN FEET AND FINGERS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMP IN FINGERS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMP IN THE CALF
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMP LEGS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMP ON BOTH FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPING LEGS (CA2+/MG ADVISED BY GP)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    CRAMPING LEGS/HANDS NOW AND THEN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    15 / 454 (3.30%)
         occurrences all number
    0
    41
    CRAMPS CALVES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS DURING THE NIGHT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    5
    CRAMPS FINGERS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS HAND AND FOOT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS HANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS IN CALVES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS IN HANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS IN HANDS AND LEG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS IN HANDS/LEGS/FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS IN LEGS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS IN THE HAND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    CRAMPS IN THE LEGS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS LEFT THUMB
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    CRAMPS LEG/ARM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS LEGS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    3
    CRAMPS RIGHT TOE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS RIGHT TOES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMPS-RIGHT TOES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CRAMS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EXTREMITY-LIMB
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    4 / 454 (0.88%)
    9 / 454 (1.98%)
         occurrences all number
    4
    14
    FACIAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    FALLEN ARCHES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    10
    FALLEN ARCHES (BOTH FEET)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FALLEN ARCHES BOTH FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FALLEN ARCHES FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    FALLEN ARCHES -FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FALLEN ARCHES IN FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    FALLEN ARCHES-FEET
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FEET NOCTURNE CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FRACTURE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    3 / 454 (0.66%)
         occurrences all number
    1
    4
    GENERALISED CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GOUT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    2 / 454 (0.44%)
         occurrences all number
    2
    2
    GOUT (R. FOOT)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GOUT L GREAT TOE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HAND AND LEG CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HAND CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HAND CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    HANDS AND CALF CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HANDS AND LEGS CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HANDS AND LEGS CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HAND'S CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HANDS CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    HEAD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INGUEN HERNA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INTERMITTANT CRAMPS IN THE HANDS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    L FOOT CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    L THUMB CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    L THUMB CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LEG CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    LEG CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    5 / 454 (1.10%)
         occurrences all number
    0
    9
    LEG CRAMPS (MILD)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LEG/ARM CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LEG/ARM CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LEGS AND HANDS CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    LEGS CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LUMBAGO
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    MASCULAR CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    -MUS WEAKNESS EXTREMITY LOWER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MUSCLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    54 / 454 (11.89%)
         occurrences all number
    1
    122
    MUSCULAR CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    7
    MUSLE SPASMS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NECK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    2 / 454 (0.44%)
    1 / 454 (0.22%)
         occurrences all number
    2
    1
    NIGHT CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    NOCTURAL CRAMPS (FEET+CALVES)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NUMBNESS IN KNEE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    NUMBNESS IN L KNEE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OCULAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OSTEOPOROSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    PELVIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PLANTAR FASCIITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    R FOOT CRAMP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    4
    R FOOT CRAMPS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RIGHT FOOT GOUT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SUBARCROMIAL IMPINGEMENT SYNDROME
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TENDON
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    5
    TENDOPATHY THIGH NIGHT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    THORAX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TRISMUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TRUNK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    Infections and infestations
    ABDOMEN NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ABSCESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    4
    AIRWAY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ATHLETE'S FOOT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ANGINA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    BLADDER (URINARY)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BONE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BORRELIOSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    BRAIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BRONCHITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    7 / 454 (1.54%)
         occurrences all number
    0
    7
    BRONCHITIS (5 DAYS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    BRONCHITIS (NORMAL ANC)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    BRONCHUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    5 / 454 (1.10%)
         occurrences all number
    0
    6
    CELLULITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CELLULITIS, LEFT LEG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CHEST INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    3
    COLD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    3 / 454 (0.66%)
         occurrences all number
    1
    3
    COLD SORES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    COLON
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    COMMON COLD WITH FEVER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CONJUNCTIVA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    2 / 454 (0.44%)
         occurrences all number
    1
    2
    CONJUNCTIVITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    5
    CYSTISIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CYSTITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    8
    DENTAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    3
    DENTAL-TOOTH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    DIVERTICULITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EAR INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    ESOPHAGITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    EXTERNAL EAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    EYE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    3
    EYE NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FEBRILE NEUTROPENIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    5
    FEVER BUTTON
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FEVER DUE TO SWOLLEN GUMS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    FISTULA WITH ABCESS IN BURSA OMENTALIS MESENTERIAL PANNICULITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    FLU
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    FLU LIKE ILLNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    GASTRIC ABCESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GENITAL CONDYLOMA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GRIPPAL SYNDROM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HAND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HEAD
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    4
    HELICOBACTER PYLORI
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    HELICOBECTER PYLORI
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    HEPATITIS B
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HERPES SIMPLEX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    HERPES VIRUS INFECTION (SHINGLES)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    HERPES ZOSTER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    2 / 454 (0.44%)
         occurrences all number
    1
    2
    HERPES ZOSTER VIRUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    ILEUM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    INF GASTRIC MOCOSA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INF GASTROENTERITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    4
    INF GASTROINTESTINAL INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    INF GASTRO-INTESTINAL INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    INF PULMONARY SEPSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INF PULMONARY/UPPER RESPIRATORY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INFECTED PIMPLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    INFECTED RIGHT EAR
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INFECTED SEBACEOUS CYST
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INFECTION ACNE OUTBREAK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INFECTION IN ORL SPHERE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INFECTION WITH UKNOWN ANC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    INFLUENZA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    5 / 454 (1.10%)
         occurrences all number
    0
    5
    INFLUENZAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    JOINT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    KIDNEY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LARYNGITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    LEFT EAR INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LEFT SIDE NECROTISING OTITIS LEFT EXTERNA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LIP
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LIVER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LOWER RESPIRATORY INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LOWER RESPIRATORY TRACT INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LUMP FLUID R ARMPIT WITH PURULENT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LUNG
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    LUNG (PNEUMONIA)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MRSA RESISTENT SEPSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    MUCOSA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MUSCLE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    MYCOSIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NAILS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    NOSE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OTH ACUTE GASTROENTERITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OTITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    PARANASAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PELVIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PELVIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    PHARINGYTIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PHARYNGITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PHARYNX
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PNEUMATIC/BRONCHITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    PNEUMONIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    3
    PNEUMONIA (VIRAL INFECTION)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    POSSIBLE RINGWORM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PROSTATE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RECTUM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    RESPIRATORY INFECTION WITHOUT NEUTROPENI
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RHINITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    RHINO-PHARINGITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    RHINOPHARYNGITIS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    RIGHT FOOT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SALIVARY GLAND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SEASONAL INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SHINGLES
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    SINUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    SKIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    2
    SMALL BOWEL NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    SPLEEN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    STITCH ABSCESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    STOMACH
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    TOOTH ABCESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TOOTH ABSCESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    TOOTH INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TOOTH SHAM
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TRACHEA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    UNGUEAL INFECTION N/A LEVURE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    UPPER AIRWAY NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    4 / 454 (0.88%)
         occurrences all number
    0
    5
    UPPER RESPIRATORY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    UPPER RESPIRATORY INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    UPPER RESPIRATORY TRACT INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    3 / 454 (0.66%)
         occurrences all number
    1
    3
    URETHRA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    URINARY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    URINARY INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    3
    URINARY TRACT INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    2 / 454 (0.44%)
         occurrences all number
    1
    2
    URINARY TRACT NOS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    URINE INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    UTERUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VAGINA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VEIN
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VIRAL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    VIRAL ILLNESS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VIRAL INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    1
    VIRAL INFECTION (COMMON COLD VIRUS)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    VIROLOFICAL HERPES ZOSTER
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    VIRUS
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    VIRUS INFECTION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    VULVA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    WOUND
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    4
    ZONA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    ALAT=40N, ASAT=20N ( HEPATO TOXICITY)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ALT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ALT, AST
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    ANOREXIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    16 / 454 (3.52%)
    55 / 454 (12.11%)
         occurrences all number
    27
    121
    BILIRUBIN INCREASE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    2
    BILIRUBIN-INCREASE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CHOLESTEROL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    CPK
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    6
    CREATININE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    4
    DEFICIENCY FE, FOLIC ACID,VIT B12
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    DEHYDRATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    GGT (82U/L)
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    GGT INCREASE
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    HEPATIC
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYPERBILIRUBINEMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYPERCHOLESTREMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYPERGLYCEMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    3 / 454 (0.66%)
         occurrences all number
    1
    10
    HYPERURICEMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    3
    HYPOCALCEMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYPOGLYCEMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    3 / 454 (0.66%)
         occurrences all number
    0
    4
    HYPOKALEMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    2 / 454 (0.44%)
         occurrences all number
    0
    9
    HYPONATREMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    HYPOPHOSPHATEMIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    6
    INCREASE GGT
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    IRON DEFICIENCY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    1
    0
    METRORRHAGIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OTH DEFICIT OF VIT B12
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    OTH IRON DEFICIENCY
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    0 / 454 (0.00%)
         occurrences all number
    2
    0
    OTH UREA = 61 MG/DL [17-43]
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    PROTEINURIA
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    1 / 454 (0.22%)
    1 / 454 (0.22%)
         occurrences all number
    1
    9
    RAISED CHOLESTEROL
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1
    TSH ELEVATION
    alternative dictionary used: CTCAE 3.0
         subjects affected / exposed
    0 / 454 (0.00%)
    1 / 454 (0.22%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2009
    In March 2009, the overall survival was estimated in the control group, to investigate whether the assumptions supporting the statistical design were verified; it became clear that the planned interim analysis of survival would not be possible before the question had lost its interest, due to a substantially better than expected survival in the control group. The IDMC strongly recommended an amendment of the protocol to change the primary end-point to time to imatinib failure.
    13 Dec 2011
    The IDMC recommended a further amendment of the protocol to change the definition of primary end-point to ‘imatinib monotherapy failure free survival’. This definition was thought to be simple, pragmatic, objective, and easier to understand than the previous definition.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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