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    Clinical Trial Results:
    Phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma

    Summary
    EudraCT number
    		 2005-005177-29
    Trial protocol
    		 DE   BE   GB   FR   LV   NL   SI  
    Global end of trial date
    01 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Aug 2021
    First version publication date
    29 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EORTC 26052-22053
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00304031
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    RTOG Foundation
    Sponsor organisation address
    50 South 16th Street, Suite 2800, Philadelphia, United States, 19102
    Public contact
    RTOG Foundation, RTOG Foundation, info@rtog.org
    Scientific contact
    RTOG Foundation, RTOG Foundation, 2155743173 2155743173, info@rtog.org
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Feb 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if dose-intensifying (increase the 'dose-density') the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by overall survival
    Protection of trial subjects
    RTOG DMC reviewed the accrual to the study and the rate of adverse events on the study at least twice a year until the initial results of the study have been presented to the scientific community. The efficacy results of this study were reviewed by the RTOG DMC four times
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jan 2006
    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
    Israel: 26
    Country: Number of subjects enrolled
    Switzerland: 7
    Country: Number of subjects enrolled
    United States: 935
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    United Kingdom: 77
    Country: Number of subjects enrolled
    Belgium: 22
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Latvia: 29
    Worldwide total number of subjects
    1125
    EEA total number of subjects
    80
    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)
    375
    From 65 to 84 years
    375
    85 years and over
    375

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Registered participants had to have MGMT (O-6-methylguanine-DNA methyltransferase) status determination in order for them to continue on the study. Of 1173 participants initially registered, 1125 participants met these requirements and started protocol treatment. 833 patients were randomized.

    Pre-assignment period milestones
    Number of subjects started
    		 1125
    Number of subjects completed
    		 833

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Disease progression: 48
    Reason: Number of subjects
    		 Ineligible due to insufficient tissue: 144
    Reason: Number of subjects
    		 Consent withdrawn by subject: 19
    Reason: Number of subjects
    		 Death: 18
    Reason: Number of subjects
    		 Physician decision: 15
    Reason: Number of subjects
    		 Adverse event, non-fatal: 10
    Reason: Number of subjects
    		 Other complicating disease: 1
    Reason: Number of subjects
    		 Other, not otherwise specified: 37
    Period 1
    Period 1 title
    Randomization (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Conventional Adjuvant TMZ
    Arm description
    		 Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.

    Arm title
    		 Dose-dense Adjuvant TMZ
    Arm description
    		 Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.

    Number of subjects in period 1 [1]
    		Conventional Adjuvant TMZ Dose-dense Adjuvant TMZ
    Started
    411
    422
    Completed
    411
    420
    Not completed
    0
    2
         No follow-up collected
    -
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1173 patient were first registered, 1125 could start RT and concomitant TMZ. Adjuvant TMZ could start for 833 patients which were randomized between the two treatment arms. The dropout reasons are explained in the pre-assignment section.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Conventional Adjuvant TMZ
    Reporting group description
    		 Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.

    Reporting group title
    Dose-dense Adjuvant TMZ
    Reporting group description
    		 Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.

    Reporting group values
    		 Conventional Adjuvant TMZ Dose-dense Adjuvant TMZ Total
    Number of subjects
    		 411 422 833
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 307 326 633
        From 65-84 years
    		 104 96 200
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 57 (22 to 84) 58 (21 to 84) -
    Gender categorical
    Units: Subjects
        Female
    		 172 185 357
        Male
    		 239 237 476

    End points

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    End points reporting groups
    Reporting group title
    Conventional Adjuvant TMZ
    Reporting group description
    		 Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.

    Reporting group title
    Dose-dense Adjuvant TMZ
    Reporting group description
    		 Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.

    Primary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    End point type
    Primary
    End point timeframe
    After treatment, survival information is collected at the conclusion of protocol therapy; then q 3 months x 1 year; then every 4 months x 1 year; then q 6 months. Also at progression/relapse and at death.
    End point values
    		 Conventional Adjuvant TMZ Dose-dense Adjuvant TMZ
    Number of subjects analysed
    411
    420 [1]
    Units: month
        median (confidence interval 95%)
    16.6 (14.9 to 18.0)
    14.9 (13.7 to 16.5)
    Notes
    [1] - For 2 patients no follow-up collected
    Statistical analysis title
    		 Overall Survival Analysis
    Statistical analysis description
    This study was looking for a 20% reduction in hazard rate: null hypothesis (conventional arm): Median survival time (MST) = 14.0 mo.; alternative hypothesis (dose-dense arm): MST= 17.5 mo. A onesided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 750 patients (647 deaths were required for the final analysis).
    Comparison groups
    Dose-dense Adjuvant TMZ v Conventional Adjuvant TMZ
    Number of subjects included in analysis
    831
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.63
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.2

    Secondary: Progression-free Survival

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    End point title
    		 Progression-free Survival
    End point description
    End point type
    Secondary
    End point timeframe
    MRI was obtained prior to surgery, post-surgery, prior to initiation of the concurrent radiation and temozolomide therapy, then within 72 hours prior to initiating adjuvant chemotherapy, then every 3 cycles, and at the time of neurologic deterioration.
    End point values
    		 Conventional Adjuvant TMZ Dose-dense Adjuvant TMZ
    Number of subjects analysed
    411
    420
    Units: Months
        median (confidence interval 95%)
    5.5 (4.7 to 6.1)
    6.7 (6.2 to 7.7)
    Statistical analysis title
    		 PFS analysis
    Comparison groups
    Conventional Adjuvant TMZ v Dose-dense Adjuvant TMZ
    Number of subjects included in analysis
    831
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.06
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1

    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 : (+give the different 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
    		 CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Conventional Adjuvant TMZ
    Reporting group description
    		 Conventional Adjuvant TMZ

    Reporting group title
    Dose-dense Adjuvant TMZ
    Reporting group description
    		 Dose-dense Adjuvant TMZ

    Serious adverse events
    		 Conventional Adjuvant TMZ Dose-dense Adjuvant TMZ
    Total subjects affected by serious adverse events
         subjects affected / exposed
    126 / 411 (30.66%)
    139 / 422 (32.94%)
         number of deaths (all causes)
    320
    332
         number of deaths resulting from adverse events
    6
    9
    Vascular disorders
    HEMATOMA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOTENSION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOSIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    15 / 411 (3.65%)
    19 / 422 (4.50%)
         occurrences causally related to treatment / all
    3 / 16
    6 / 22
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    DEATH NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    DISEASE PROGRESSION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    EDEMA: HEAD AND NECK:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EDEMA: LIMB:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (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: CTCAE 3
         subjects affected / exposed
    9 / 411 (2.19%)
    10 / 422 (2.37%)
         occurrences causally related to treatment / all
    13 / 13
    9 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GAIT ABNORMAL NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFLUENZA-LIKE ILLNESS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAIN NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYREXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    7 / 422 (1.66%)
         occurrences causally related to treatment / all
    4 / 5
    4 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RIGORS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUDDEN DEATH
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    CYTOKINE RELEASE SYNDROME
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERSENSITIVITY NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ASPIRATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    COUGH
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPNOEA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    7 / 422 (1.66%)
         occurrences causally related to treatment / all
    5 / 6
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    6 / 422 (1.42%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NASAL CAVITY/PARANASAL SINUS REACTIONS:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    6 / 422 (1.42%)
         occurrences causally related to treatment / all
    1 / 4
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY/UPPER RESPIRATORY - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT HEMORRHAGE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    AGITATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONFUSIONAL STATE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    12 / 411 (2.92%)
    8 / 422 (1.90%)
         occurrences causally related to treatment / all
    4 / 14
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEPRESSION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INSOMNIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERSONALITY CHANGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PSYCHOSIS AGGRAVATED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASPARTATE AMINOTRANSFERASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD ALKALINE PHOSPHATASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD AMYLASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD BILIRUBIN INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD CREATININE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CD4 LYMPHOCYTES DECREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    6 / 422 (1.42%)
         occurrences causally related to treatment / all
    0 / 0
    13 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LEUKOPENIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    15 / 411 (3.65%)
    14 / 422 (3.32%)
         occurrences causally related to treatment / all
    17 / 18
    13 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIPASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LYMPHOPENIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    23 / 422 (5.45%)
         occurrences causally related to treatment / all
    8 / 8
    34 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METABOLIC/LABORATORY - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPHIL COUNT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    15 / 411 (3.65%)
    11 / 422 (2.61%)
         occurrences causally related to treatment / all
    15 / 16
    10 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLATELET COUNT DECREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    20 / 411 (4.87%)
    16 / 422 (3.79%)
         occurrences causally related to treatment / all
    23 / 24
    16 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TROPONIN I INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WEIGHT DECREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FRACTURE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR ACCESS NOS COMPLICATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FIBRILLATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL TACHYCARDIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUS BRADYCARDIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUS TACHYCARDIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUPRAVENTRICULAR EXTRASYSTOLES
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    ATAXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL ISCHAEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    4 / 422 (0.95%)
         occurrences causally related to treatment / all
    1 / 4
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBROSPINAL FLUID LEAK
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CNS NECROSIS/CYSTIC PROGRESSION:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COGNITIVE DISORDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    4 / 422 (0.95%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CONVULSIONS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    20 / 411 (4.87%)
    24 / 422 (5.69%)
         occurrences causally related to treatment / all
    5 / 22
    10 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEPRESSED LEVEL OF CONSCIOUSNESS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIZZINESS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    1 / 5
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSGEUSIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALOPATHY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    EXTRAPYRAMIDAL DISORDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEADACHE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    7 / 422 (1.66%)
         occurrences causally related to treatment / all
    3 / 6
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYDROCEPHALUS ACQUIRED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERREFLEXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEMORY IMPAIRMENT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    2 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENTAL STATUS CHANGES
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): FACIAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEURALGIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUROLOGY - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    4 / 422 (0.95%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUROPATHY: CRANIAL: CN VIII HEARING AND BALANCE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL MOTOR NEUROPATHY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    7 / 422 (1.66%)
         occurrences causally related to treatment / all
    1 / 8
    3 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL SENSORY NEUROPATHY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPEECH DISORDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYNCOPE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYNCOPE VASOVAGAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TREMOR
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    BLOOD/BONE MARROW - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BONE MARROW DEPRESSION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEBRILE NEUTROPENIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    HAEMOLYSIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEMOGLOBIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    5 / 422 (1.18%)
         occurrences causally related to treatment / all
    5 / 5
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOTIC MICROANGIOPATHY NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Eye disorders
    DIPLOPIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXTRAOCULAR MUSCLE DISORDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OCULAR/VISUAL - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETINAL DETACHMENT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VISION BLURRED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLONIC PERFORATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONSTIPATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPHAGIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NAUSEA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    10 / 422 (2.37%)
         occurrences causally related to treatment / all
    4 / 4
    8 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RECTAL HEMORRHAGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    8 / 422 (1.90%)
         occurrences causally related to treatment / all
    2 / 3
    6 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC FAILURE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    ACNE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DERMATITIS EXFOLIATIVE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAIN OF SKIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PETECHIAE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    CYSTITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL FAILURE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY INCONTINENCE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    CUSHINGOID
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE WEAKNESS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    9 / 422 (2.13%)
         occurrences causally related to treatment / all
    2 / 3
    5 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): EXTREMITY-LOWER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): EXTREMITY-UPPER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): LEFT-SIDED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): RIGHT-SIDED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAIN IN EXTREMITY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    ABDOMINAL INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BONE INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EYE INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    5 / 6
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): BILIARY TREE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): BLADDER (URINARY)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): KIDNEY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): LUNG (PNEUMONIA)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    4 / 422 (0.95%)
         occurrences causally related to treatment / all
    1 / 2
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): RECTUM
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: NERVE-PERIPHERAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: WOUND
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION WITH UNKNOWN ANC: LUNG (PNEUMONIA)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION WITH UNKNOWN ANC: SKIN (CELLULITIS)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTOUS MENINGITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OPPORTUNISITIC INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    5 / 422 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    PNEUMONIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    3 / 422 (0.71%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUSITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    ACIDOSIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ALKALOSIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANOREXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    5 / 422 (1.18%)
         occurrences causally related to treatment / all
    2 / 3
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEHYDRATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    7 / 422 (1.66%)
         occurrences causally related to treatment / all
    1 / 2
    4 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERGLYCAEMIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    2 / 422 (0.47%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOALBUMINEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    4 / 422 (0.95%)
         occurrences causally related to treatment / all
    0 / 2
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOGLYCEMIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOKALEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    6 / 422 (1.42%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOMAGNESEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPONATREMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    1 / 422 (0.24%)
         occurrences causally related to treatment / all
    1 / 8
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Conventional Adjuvant TMZ Dose-dense Adjuvant TMZ
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    383 / 411 (93.19%)
    397 / 422 (94.08%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    SECONDARY MALIGNANCY - POSSIBLY RELATED TO CANCER TREATMENT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    FLUSHING
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    2 / 422 (0.47%)
         occurrences all number
    5
    2
    HEMATOMA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    5 / 422 (1.18%)
         occurrences all number
    1
    5
    HEMORRHAGE/BLEEDING - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    4 / 422 (0.95%)
         occurrences all number
    3
    5
    HOT FLUSHES NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    5 / 422 (1.18%)
         occurrences all number
    8
    7
    HYPERTENSION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    7 / 422 (1.66%)
         occurrences all number
    10
    15
    HYPOTENSION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    17 / 422 (4.03%)
         occurrences all number
    7
    26
    LYMPHOEDEMA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    PHLEBITIS SUPERFICIAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    2 / 422 (0.47%)
         occurrences all number
    2
    2
    THROMBOSIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    28 / 411 (6.81%)
    33 / 422 (7.82%)
         occurrences all number
    42
    40
    VASCULAR - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    CHEST PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    10 / 422 (2.37%)
         occurrences all number
    7
    10
    CONSTITUTIONAL SYMPTOMS - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    9 / 422 (2.13%)
         occurrences all number
    7
    28
    DEATH NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    DISEASE PROGRESSION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    3 / 422 (0.71%)
         occurrences all number
    4
    3
    EDEMA: HEAD AND NECK:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    14 / 411 (3.41%)
    26 / 422 (6.16%)
         occurrences all number
    24
    49
    EDEMA: LIMB:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    48 / 411 (11.68%)
    53 / 422 (12.56%)
         occurrences all number
    91
    107
    EDEMA: TRUNK/GENITAL:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    2
    EDEMA: VISCERA:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    FACIAL PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    2 / 422 (0.47%)
         occurrences all number
    6
    2
    FATIGUE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    291 / 411 (70.80%)
    318 / 422 (75.36%)
         occurrences all number
    1108
    1347
    GAIT ABNORMAL NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    15 / 411 (3.65%)
    13 / 422 (3.08%)
         occurrences all number
    46
    28
    INFLUENZA-LIKE ILLNESS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    8 / 422 (1.90%)
         occurrences all number
    3
    9
    INJECTION SITE REACTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    IRRITABILITY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    PAIN - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    27 / 411 (6.57%)
    23 / 422 (5.45%)
         occurrences all number
    50
    46
    PAIN NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    10 / 411 (2.43%)
    8 / 422 (1.90%)
         occurrences all number
    15
    9
    PYREXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    28 / 411 (6.81%)
    31 / 422 (7.35%)
         occurrences all number
    34
    43
    RIGORS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    13 / 411 (3.16%)
    14 / 422 (3.32%)
         occurrences all number
    19
    17
    SUDDEN DEATH
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    2
    Immune system disorders
    ALLERGY/IMMUNOLOGY - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    3 / 422 (0.71%)
         occurrences all number
    3
    4
    CYTOKINE RELEASE SYNDROME
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    HYPERSENSITIVITY NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    10 / 411 (2.43%)
    11 / 422 (2.61%)
         occurrences all number
    13
    14
    Reproductive system and breast disorders
    BREAST FUNCTION/LACTATION:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    ERECTILE DYSFUNCTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences all number
    8
    6
    GYNAECOMASTIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    MENSTRUATION IRREGULAR
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): PELVIC
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    SEXUAL/REPRODUCTIVE FUNCTION - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    2
    TESTICULAR PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    VAGINAL DISCHARGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    2
    VAGINAL HEMORRHAGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY DISTRESS SYNDROME
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    ASPIRATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    1 / 422 (0.24%)
         occurrences all number
    3
    1
    ATELECTASIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    BRONCHOSPASM
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    5 / 422 (1.18%)
         occurrences all number
    0
    7
    COUGH
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    49 / 411 (11.92%)
    54 / 422 (12.80%)
         occurrences all number
    87
    92
    DYSPNOEA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    38 / 411 (9.25%)
    41 / 422 (9.72%)
         occurrences all number
    76
    83
    EPISTAXIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    8 / 411 (1.95%)
    4 / 422 (0.95%)
         occurrences all number
    8
    8
    HICCUPS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    0 / 422 (0.00%)
         occurrences all number
    5
    0
    HYPOXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    10 / 422 (2.37%)
         occurrences all number
    2
    15
    LARYNGEAL DISCOMFORT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    3 / 422 (0.71%)
         occurrences all number
    0
    3
    LARYNGITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    7 / 422 (1.66%)
         occurrences all number
    3
    11
    MUCOSITIS/STOMATITIS (CLINICAL EXAM): PHARYNX
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC): PHARYNX
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    NASAL CAVITY/PARANASAL SINUS REACTIONS:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    7 / 422 (1.66%)
         occurrences all number
    1
    11
    OBSTRUCTION/STENOSIS OF AIRWAY: PHARYNX
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    4
    PHARYNGOLARYNGEAL PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    8 / 411 (1.95%)
    10 / 422 (2.37%)
         occurrences all number
    14
    17
    PLEURAL EFFUSION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    PLEURITIC PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    PNEUMONITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    9 / 411 (2.19%)
    11 / 422 (2.61%)
         occurrences all number
    9
    13
    PROLONGED CHEST TUBE DRAINAGE OR AIR LEAK AFTER PULMONARY RESECTION:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    PULMONARY/UPPER RESPIRATORY - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    9 / 411 (2.19%)
    17 / 422 (4.03%)
         occurrences all number
    10
    23
    RESPIRATORY TRACT HEMORRHAGE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    RHINITIS ALLERGIC NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    13 / 422 (3.08%)
         occurrences all number
    8
    28
    Psychiatric disorders
    AGITATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    26 / 411 (6.33%)
    14 / 422 (3.32%)
         occurrences all number
    44
    19
    ANXIETY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    48 / 411 (11.68%)
    41 / 422 (9.72%)
         occurrences all number
    96
    100
    CONFUSIONAL STATE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    63 / 411 (15.33%)
    61 / 422 (14.45%)
         occurrences all number
    102
    97
    DEPRESSION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    54 / 411 (13.14%)
    61 / 422 (14.45%)
         occurrences all number
    112
    138
    EUPHORIC MOOD
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INSOMNIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    84 / 411 (20.44%)
    75 / 422 (17.77%)
         occurrences all number
    163
    148
    LIBIDO DECREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    3 / 422 (0.71%)
         occurrences all number
    4
    6
    PERSONALITY CHANGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    18 / 411 (4.38%)
    13 / 422 (3.08%)
         occurrences all number
    26
    16
    PSYCHOSIS AGGRAVATED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    7 / 422 (1.66%)
         occurrences all number
    8
    7
    Investigations
    ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    6 / 422 (1.42%)
         occurrences all number
    2
    14
    ALANINE AMINOTRANSFERASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    102 / 411 (24.82%)
    111 / 422 (26.30%)
         occurrences all number
    235
    250
    ASPARTATE AMINOTRANSFERASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    65 / 411 (15.82%)
    71 / 422 (16.82%)
         occurrences all number
    114
    124
    BLOOD ALKALINE PHOSPHATASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    46 / 411 (11.19%)
    51 / 422 (12.09%)
         occurrences all number
    126
    95
    BLOOD AMYLASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    4 / 422 (0.95%)
         occurrences all number
    4
    5
    BLOOD BILIRUBIN INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    18 / 411 (4.38%)
    22 / 422 (5.21%)
         occurrences all number
    40
    37
    BLOOD CREATINE PHOSPHOKINASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    2
    BLOOD CREATININE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    24 / 411 (5.84%)
    33 / 422 (7.82%)
         occurrences all number
    35
    53
    BLOOD HUMAN CHORIONIC GONADOTROPIN ABNORMAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    CD4 LYMPHOCYTES DECREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    13 / 411 (3.16%)
    33 / 422 (7.82%)
         occurrences all number
    25
    96
    COAGULOPATHY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    18 / 411 (4.38%)
    19 / 422 (4.50%)
         occurrences all number
    69
    43
    HAPTOGLOBIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    2
    HYPERCHOLESTEROLAEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    2 / 422 (0.47%)
         occurrences all number
    8
    6
    INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    LEUKOPENIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    157 / 411 (38.20%)
    191 / 422 (45.26%)
         occurrences all number
    662
    857
    LIPASE INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    7 / 422 (1.66%)
         occurrences all number
    1
    17
    LYMPHOPENIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    167 / 411 (40.63%)
    179 / 422 (42.42%)
         occurrences all number
    749
    1113
    METABOLIC/LABORATORY - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    39 / 411 (9.49%)
    39 / 422 (9.24%)
         occurrences all number
    130
    159
    NEUTROPHIL COUNT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    97 / 411 (23.60%)
    110 / 422 (26.07%)
         occurrences all number
    263
    298
    PLATELET COUNT DECREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    169 / 411 (41.12%)
    164 / 422 (38.86%)
         occurrences all number
    579
    533
    PROTHROMBIN TIME PROLONGED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    7 / 422 (1.66%)
         occurrences all number
    2
    31
    TROPONIN I INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    WEIGHT DECREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    51 / 411 (12.41%)
    73 / 422 (17.30%)
         occurrences all number
    117
    201
    WEIGHT INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    18 / 411 (4.38%)
    14 / 422 (3.32%)
         occurrences all number
    41
    18
    Injury, poisoning and procedural complications
    BURN:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences all number
    3
    1
    CULTURE WOUND NEGATIVE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    3 / 422 (0.71%)
         occurrences all number
    2
    4
    DERMATITIS RADIATION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    96 / 411 (23.36%)
    103 / 422 (24.41%)
         occurrences all number
    109
    121
    ECCHYMOSIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    12 / 411 (2.92%)
    13 / 422 (3.08%)
         occurrences all number
    23
    21
    FRACTURE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    4 / 422 (0.95%)
         occurrences all number
    4
    4
    INTRA-OPERATIVE INJURY: APPENDIX
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INTRA-OPERATIVE INJURY: THORACIC DUCT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    RADIATION RECALL SYNDROME
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    20 / 411 (4.87%)
    26 / 422 (6.16%)
         occurrences all number
    23
    28
    VASCULAR ACCESS NOS COMPLICATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    4 / 422 (0.95%)
         occurrences all number
    10
    8
    VESSEL INJURY-ARTERY: OTHER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    ANGINA PECTORIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    2
    ARRHYTHMIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    ATRIAL FIBRILLATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    2 / 422 (0.47%)
         occurrences all number
    5
    3
    ATRIAL TACHYCARDIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    CARDIAC GENERAL - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    3 / 422 (0.71%)
         occurrences all number
    0
    4
    LEFT VENTRICULAR FAILURE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    MYOCARDIAL ISCHAEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    PALPITATIONS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    5 / 422 (1.18%)
         occurrences all number
    5
    6
    SINUS BRADYCARDIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    2
    SINUS TACHYCARDIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    6 / 422 (1.42%)
         occurrences all number
    3
    11
    SUPRAVENTRICULAR EXTRASYSTOLES
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    SUPRAVENTRICULAR TACHYCARDIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    VENTRICULAR FIBRILLATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    VENTRICULAR TACHYCARDIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    ACCESSORY NERVE DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    ARACHNOIDITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    2
    ATAXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    52 / 411 (12.65%)
    56 / 422 (13.27%)
         occurrences all number
    95
    114
    CEREBRAL ISCHAEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    6 / 422 (1.42%)
         occurrences all number
    7
    6
    CEREBROSPINAL FLUID LEAK
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    3
    CNS NECROSIS/CYSTIC PROGRESSION:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    3 / 422 (0.71%)
         occurrences all number
    6
    3
    COGNITIVE DISORDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    31 / 411 (7.54%)
    37 / 422 (8.77%)
         occurrences all number
    60
    62
    CONVULSIONS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    89 / 411 (21.65%)
    98 / 422 (23.22%)
         occurrences all number
    187
    175
    DEPRESSED LEVEL OF CONSCIOUSNESS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    17 / 411 (4.14%)
    25 / 422 (5.92%)
         occurrences all number
    23
    33
    DIZZINESS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    90 / 411 (21.90%)
    75 / 422 (17.77%)
         occurrences all number
    161
    167
    DYSGEUSIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    43 / 411 (10.46%)
    63 / 422 (14.93%)
         occurrences all number
    90
    126
    ENCEPHALOPATHY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    5 / 422 (1.18%)
         occurrences all number
    2
    5
    EXTRAPYRAMIDAL DISORDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    7 / 422 (1.66%)
         occurrences all number
    10
    10
    FACIAL NERVE DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    14 / 411 (3.41%)
    12 / 422 (2.84%)
         occurrences all number
    27
    18
    GLOSSOPHARYNGEAL NERVE DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    HEADACHE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    189 / 411 (45.99%)
    197 / 422 (46.68%)
         occurrences all number
    513
    540
    HEMORRHAGIC STROKE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    3 / 422 (0.71%)
         occurrences all number
    1
    3
    HYDROCEPHALUS ACQUIRED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    4 / 422 (0.95%)
         occurrences all number
    5
    5
    HYPERREFLEXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    25 / 411 (6.08%)
    23 / 422 (5.45%)
         occurrences all number
    60
    60
    MEMORY IMPAIRMENT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    79 / 411 (19.22%)
    79 / 422 (18.72%)
         occurrences all number
    196
    183
    MENTAL STATUS CHANGES
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    4 / 422 (0.95%)
         occurrences all number
    11
    6
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): FACIAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    1 / 422 (0.24%)
         occurrences all number
    8
    1
    NEURALGIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    3 / 422 (0.71%)
         occurrences all number
    11
    5
    NEUROLOGY - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    32 / 411 (7.79%)
    35 / 422 (8.29%)
         occurrences all number
    55
    57
    NEUROPATHY: CRANIAL: CN VIII HEARING AND BALANCE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    4 / 422 (0.95%)
         occurrences all number
    16
    13
    NYSTAGMUS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    3 / 422 (0.71%)
         occurrences all number
    2
    4
    OCULOMOTOR NERVE OPERATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    1 / 422 (0.24%)
         occurrences all number
    3
    7
    OLFACTORY NERVE DISORDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    2 / 422 (0.47%)
         occurrences all number
    2
    2
    PERIPHERAL MOTOR NEUROPATHY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    56 / 411 (13.63%)
    65 / 422 (15.40%)
         occurrences all number
    108
    142
    PERIPHERAL SENSORY NEUROPATHY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    56 / 411 (13.63%)
    62 / 422 (14.69%)
         occurrences all number
    103
    165
    RADICULITIS BRACHIAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    3
    0
    SINUS PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    3
    SPEECH DISORDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    60 / 411 (14.60%)
    60 / 422 (14.22%)
         occurrences all number
    155
    143
    SYNCOPE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    6 / 422 (1.42%)
         occurrences all number
    6
    6
    SYNCOPE VASOVAGAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    1 / 422 (0.24%)
         occurrences all number
    3
    1
    TREMOR
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    51 / 411 (12.41%)
    42 / 422 (9.95%)
         occurrences all number
    93
    122
    TRIGEMINAL NERVE DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences all number
    3
    1
    VITH NERVE DISORDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    4
    5
    Blood and lymphatic system disorders
    BLOOD/BONE MARROW - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    13 / 411 (3.16%)
    13 / 422 (3.08%)
         occurrences all number
    51
    59
    BONE MARROW DEPRESSION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    FEBRILE NEUTROPENIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences all number
    3
    2
    HAEMOLYSIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    HEMOGLOBIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    139 / 411 (33.82%)
    173 / 422 (41.00%)
         occurrences all number
    505
    581
    LYMPHATICS - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    3 / 422 (0.71%)
         occurrences all number
    4
    3
    SPLEEN DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    6
    1
    THROMBOTIC MICROANGIOPATHY NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    2
    1
    Ear and labyrinth disorders
    AUDITORY/EAR - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    14 / 411 (3.41%)
    11 / 422 (2.61%)
         occurrences all number
    24
    18
    EAR PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    8 / 422 (1.90%)
         occurrences all number
    7
    12
    HEARING DISABILITY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    2
    HEARING IMPAIRED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    26 / 411 (6.33%)
    19 / 422 (4.50%)
         occurrences all number
    69
    37
    OTITIS EXTERNA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    8 / 411 (1.95%)
    10 / 422 (2.37%)
         occurrences all number
    15
    16
    OTITIS MEDIA SEROUS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    7 / 422 (1.66%)
         occurrences all number
    3
    11
    PAIN: EXTERNAL EAR
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    2
    2
    TINNITUS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    12 / 411 (2.92%)
    11 / 422 (2.61%)
         occurrences all number
    23
    18
    Eye disorders
    CATARACT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    4 / 422 (0.95%)
         occurrences all number
    1
    11
    CONJUNCTIVITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences all number
    2
    1
    DIPLOPIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    10 / 411 (2.43%)
    8 / 422 (1.90%)
         occurrences all number
    38
    20
    DRY EYE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    9 / 422 (2.13%)
         occurrences all number
    4
    13
    EXTRAOCULAR MUSCLE DISORDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    4 / 422 (0.95%)
         occurrences all number
    6
    4
    EYE PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    8 / 422 (1.90%)
         occurrences all number
    5
    14
    EYELID FUNCTION DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    5 / 422 (1.18%)
         occurrences all number
    1
    10
    GLAUCOMA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    LACRIMATION INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    11 / 422 (2.61%)
         occurrences all number
    8
    21
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): OCULAR
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    OCULAR/VISUAL - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    35 / 411 (8.52%)
    27 / 422 (6.40%)
         occurrences all number
    78
    67
    OPTIC DISC DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    2 / 422 (0.47%)
         occurrences all number
    8
    3
    OPTIC NERVE DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    13 / 411 (3.16%)
    12 / 422 (2.84%)
         occurrences all number
    31
    18
    PHOTOPHOBIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    6 / 422 (1.42%)
         occurrences all number
    4
    10
    PHOTOPSIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    3 / 422 (0.71%)
         occurrences all number
    14
    4
    PROPTOSIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    2 / 422 (0.47%)
         occurrences all number
    2
    4
    RETINAL DETACHMENT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    4
    0
    UVEITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    VISION BLURRED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    44 / 411 (10.71%)
    54 / 422 (12.80%)
         occurrences all number
    98
    110
    Gastrointestinal disorders
    ABDOMINAL DISTENTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    3 / 422 (0.71%)
         occurrences all number
    4
    6
    ABDOMINAL PAIN NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    17 / 411 (4.14%)
    25 / 422 (5.92%)
         occurrences all number
    24
    37
    ANAL DISCOMFORT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    ANAL HAEMORRHAGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    COLITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    COLONIC PERFORATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    2
    CONSTIPATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    134 / 411 (32.60%)
    127 / 422 (30.09%)
         occurrences all number
    297
    336
    DIARRHOEA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    48 / 411 (11.68%)
    74 / 422 (17.54%)
         occurrences all number
    73
    127
    DRY MOUTH
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    22 / 411 (5.35%)
    26 / 422 (6.16%)
         occurrences all number
    36
    56
    DYSPEPSIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    30 / 411 (7.30%)
    30 / 422 (7.11%)
         occurrences all number
    43
    39
    DYSPHAGIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    9 / 411 (2.19%)
    14 / 422 (3.32%)
         occurrences all number
    10
    19
    ENTERITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    ESOPHAGEAL PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    ESOPHAGEAL ULCER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    FAECAL INCONTINENCE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    7 / 422 (1.66%)
         occurrences all number
    5
    9
    FLATULENCE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    5 / 422 (1.18%)
         occurrences all number
    2
    5
    GASTRIC ULCER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    3
    0
    GASTRITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    4 / 422 (0.95%)
         occurrences all number
    1
    4
    GASTROINTESTINAL - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    12 / 411 (2.92%)
    9 / 422 (2.13%)
         occurrences all number
    17
    23
    GASTROINTESTINAL PAIN NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    3 / 422 (0.71%)
         occurrences all number
    0
    10
    HEMORRHOIDS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    2 / 422 (0.47%)
         occurrences all number
    6
    2
    ILEUS PARALYTIC
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    LIP PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    LOWER GASTROINTESTINAL HEMORRHAGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    MOUTH HAEMORRHAGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    MUCOSITIS/STOMATITIS (CLINICAL EXAM): ANUS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    2
    NAUSEA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    225 / 411 (54.74%)
    228 / 422 (54.03%)
         occurrences all number
    517
    598
    ORAL PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    4 / 422 (0.95%)
         occurrences all number
    4
    4
    OSEOPHAGITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences all number
    2
    1
    PAIN: PERITONEUM
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    PANCREATIC HEMORRHAGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    PANCREATITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    PERIDONTAL DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    2
    7
    PROCTALGIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    3
    RADIATION MUCOSITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    5 / 422 (1.18%)
         occurrences all number
    4
    7
    RECTAL HEMORRHAGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    3 / 422 (0.71%)
         occurrences all number
    5
    3
    SALIVARY GLAND DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    0 / 422 (0.00%)
         occurrences all number
    3
    0
    STOMACH DISCOMFORT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    2 / 422 (0.47%)
         occurrences all number
    5
    2
    STOMATITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    19 / 411 (4.62%)
    24 / 422 (5.69%)
         occurrences all number
    20
    33
    STRICTURE/STENOSIS (INCLUDING ANASTOMOTIC), GI: PANCREAS/PANCREATIC DUCT
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    TOOTH DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    6
    0
    TOOTHACHE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    1 / 422 (0.24%)
         occurrences all number
    3
    1
    VOMITING NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    114 / 411 (27.74%)
    120 / 422 (28.44%)
         occurrences all number
    190
    207
    Hepatobiliary disorders
    CHOLECYSTITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences all number
    4
    1
    GALLBLADDER PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences all number
    2
    1
    HEPATIC FAILURE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    HEPATOBILIARY/PANCREAS - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    ACNE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    8 / 411 (1.95%)
    7 / 422 (1.66%)
         occurrences all number
    11
    8
    ALOPECIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    172 / 411 (41.85%)
    190 / 422 (45.02%)
         occurrences all number
    437
    515
    DECUBITUS ULCER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    2
    DERMATITIS EXFOLIATIVE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    63 / 411 (15.33%)
    77 / 422 (18.25%)
         occurrences all number
    109
    128
    DERMATOLOGY/SKIN - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    15 / 411 (3.65%)
    18 / 422 (4.27%)
         occurrences all number
    17
    31
    DRY SKIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    19 / 411 (4.62%)
    17 / 422 (4.03%)
         occurrences all number
    51
    24
    ERYTHEMA MULTIFORME
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    6 / 422 (1.42%)
         occurrences all number
    5
    7
    FAT ATROPHY NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    2
    LOCALISED EXFOLIATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    3 / 422 (0.71%)
         occurrences all number
    4
    4
    NAIL DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    2 / 422 (0.47%)
         occurrences all number
    12
    5
    PAIN OF SKIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    4 / 422 (0.95%)
         occurrences all number
    4
    5
    PAIN: SCALP
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    4 / 422 (0.95%)
         occurrences all number
    8
    5
    PETECHIAE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    2 / 422 (0.47%)
         occurrences all number
    8
    4
    PHOTOSENSITIVITY REACTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    2 / 422 (0.47%)
         occurrences all number
    4
    2
    PRURITUS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    43 / 411 (10.46%)
    53 / 422 (12.56%)
         occurrences all number
    81
    71
    SKIN HYPERPIGMENTATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    10 / 411 (2.43%)
    10 / 422 (2.37%)
         occurrences all number
    17
    16
    SKIN HYPOPIGMENTATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    5
    SWEATING INCREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    4 / 422 (0.95%)
         occurrences all number
    14
    8
    ULCERATION:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences all number
    3
    5
    URTICARIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    3 / 422 (0.71%)
         occurrences all number
    3
    4
    Renal and urinary disorders
    BLADDER PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    BLADDER SPASM
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    CHROMATURIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    3 / 422 (0.71%)
         occurrences all number
    0
    3
    CYSTITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    6 / 422 (1.42%)
         occurrences all number
    2
    8
    GLOMERULAR FILTRATION RATE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences all number
    8
    3
    HEMOGLOBINURIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    3 / 422 (0.71%)
         occurrences all number
    11
    3
    PERFORATION, GU: SPERMATIC CORD
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    POLLAKIURIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    20 / 411 (4.87%)
    20 / 422 (4.74%)
         occurrences all number
    30
    41
    PROTEINURIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    3 / 422 (0.71%)
         occurrences all number
    3
    3
    RENAL FAILURE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    3 / 422 (0.71%)
         occurrences all number
    1
    3
    RENAL/GENITOURINARY - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    4 / 422 (0.95%)
         occurrences all number
    3
    5
    URETERIC OBSTRUCTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    URETHRAL OBSTRUCTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    URINARY BLADDER HEMORRHAGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    URINARY INCONTINENCE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    14 / 411 (3.41%)
    22 / 422 (5.21%)
         occurrences all number
    22
    36
    URINARY RETENTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    3 / 422 (0.71%)
         occurrences all number
    8
    4
    UROGENITAL HEMORRHAGE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    Endocrine disorders
    CUSHINGOID
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    15 / 411 (3.65%)
    13 / 422 (3.08%)
         occurrences all number
    28
    26
    ENDOCRINE - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    5 / 422 (1.18%)
         occurrences all number
    2
    13
    HYPOTHYROIDISM
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    THYROTOXICOSIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    26 / 411 (6.33%)
    30 / 422 (7.11%)
         occurrences all number
    78
    80
    ARTHRITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    3 / 422 (0.71%)
         occurrences all number
    2
    4
    BACK PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    22 / 411 (5.35%)
    24 / 422 (5.69%)
         occurrences all number
    59
    38
    BONE PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    5 / 422 (1.18%)
         occurrences all number
    6
    8
    BUTTOCK PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    CHEST WALL PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    5 / 422 (1.18%)
         occurrences all number
    1
    5
    EXTREMITY-UPPER (FUNCTION):
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    1 / 422 (0.24%)
         occurrences all number
    3
    1
    JOINT DISORDER NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    3 / 422 (0.71%)
         occurrences all number
    13
    9
    MUSCLE WEAKNESS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    40 / 411 (9.73%)
    51 / 422 (12.09%)
         occurrences all number
    76
    98
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): EXTREMITY-LOWER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    31 / 411 (7.54%)
    25 / 422 (5.92%)
         occurrences all number
    55
    50
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): EXTREMITY-UPPER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    17 / 411 (4.14%)
    10 / 422 (2.37%)
         occurrences all number
    29
    17
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): LEFT-SIDED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    21 / 411 (5.11%)
    16 / 422 (3.79%)
         occurrences all number
    64
    33
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): RIGHT-SIDED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    8 / 422 (1.90%)
         occurrences all number
    5
    11
    MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY): TRUNK
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    MUSCULOSKELETAL/SOFT TISSUE - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    13 / 411 (3.16%)
    14 / 422 (3.32%)
         occurrences all number
    24
    29
    MYALGIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    13 / 411 (3.16%)
    22 / 422 (5.21%)
         occurrences all number
    25
    45
    NECK PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    12 / 411 (2.92%)
    9 / 422 (2.13%)
         occurrences all number
    20
    11
    OSTEOPOROSIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    PAIN IN EXTREMITY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    23 / 411 (5.60%)
    31 / 422 (7.35%)
         occurrences all number
    44
    47
    SOFT TISSUE NECROSIS: HEAD
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    TRISMUS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    Infections and infestations
    ABDOMINAL INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    ADENOVIRAL HEPATITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    BLADDER INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    6 / 422 (1.42%)
         occurrences all number
    2
    6
    ANO-RECTAL INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    2
    BONE INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences all number
    3
    0
    BRONCHITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    6 / 422 (1.42%)
         occurrences all number
    2
    6
    CLOSTRIDIAL INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    EAR INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    ENCEPHALITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    EYE INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    5 / 422 (1.18%)
         occurrences all number
    1
    5
    GENITAL INFECTION NOS, FEMALE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    GINGIVAL INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    3 / 422 (0.71%)
         occurrences all number
    9
    4
    INFECTION - OTHER:
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    17 / 411 (4.14%)
    17 / 422 (4.03%)
         occurrences all number
    22
    25
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): BILIARY TREE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): BLADDER (URINARY)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    2
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): BRAIN (ENCEPHALITIS, INFECTIOUS)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): EXTERNAL EAR (OTITIS EXTERNA)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): GALLBLADDER (CHOLECYSTITIS)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): KIDNEY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): LUNG (PNEUMONIA)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    6 / 422 (1.42%)
         occurrences all number
    2
    12
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): NOSE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): ORAL CAVITY-GUMS (GINGIVITIS)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    2
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): PARANASAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): RECTUM
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): SOFT TISSUE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): UPPER AIRWAY NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L): URINARY TRACT NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    4
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: APPENDIX
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: ARTERY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: BLOOD
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    3
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: COLON
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: CONJUNCTIVA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: ESOPHAGUS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: EXTERNAL EAR (OTITIS EXTERNA)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    0 / 422 (0.00%)
         occurrences all number
    3
    0
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: LIP/PERIORAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: NERVE-PERIPHERAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 422 (0.00%)
         occurrences all number
    2
    0
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: PARANASAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: UPPER AERODIGESTIVE NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS: WOUND
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    4 / 422 (0.95%)
         occurrences all number
    4
    6
    INFECTION WITH UNKNOWN ANC: BLADDER (URINARY)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    INFECTION WITH UNKNOWN ANC: BRAIN (ENCEPHALITIS, INFECTIOUS)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    INFECTION WITH UNKNOWN ANC: LIP/PERIORAL
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    INFECTION WITH UNKNOWN ANC: LUNG (PNEUMONIA)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    INFECTION WITH UNKNOWN ANC: ORAL CAVITY-GUMS (GINGIVITIS)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    2
    INFECTION WITH UNKNOWN ANC: SINUS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    2
    INFECTION WITH UNKNOWN ANC: SKIN (CELLULITIS)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    0 / 422 (0.00%)
         occurrences all number
    3
    0
    INFECTION WITH UNKNOWN ANC: UNGUAL (NAILS)
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    2
    INFECTION WITH UNKNOWN ANC: URINARY TRACT NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 411 (0.73%)
    2 / 422 (0.47%)
         occurrences all number
    3
    2
    INFECTOUS MENINGITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    2
    NASOPHARYNGITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    2 / 422 (0.47%)
         occurrences all number
    0
    3
    OPPORTUNISITIC INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    9 / 422 (2.13%)
         occurrences all number
    9
    13
    OTITIS MEDIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    2
    PHARYNGITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    3 / 422 (0.71%)
         occurrences all number
    1
    3
    PNEUMONIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 411 (1.22%)
    9 / 422 (2.13%)
         occurrences all number
    5
    10
    RESPIRATORY TRACT INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    8 / 411 (1.95%)
    18 / 422 (4.27%)
         occurrences all number
    10
    22
    RHINITIS INFECTIVE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    2 / 422 (0.47%)
         occurrences all number
    6
    2
    SEPSIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    SINUSITIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    5 / 422 (1.18%)
         occurrences all number
    1
    7
    SKIN INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    8 / 411 (1.95%)
    9 / 422 (2.13%)
         occurrences all number
    8
    11
    SOFT TISSUE INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    TOOTH INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    2 / 422 (0.47%)
         occurrences all number
    1
    2
    URINARY TRACT INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    7 / 422 (1.66%)
         occurrences all number
    4
    8
    VAGINAL INFECTION NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    WOUND INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    4 / 422 (0.95%)
         occurrences all number
    2
    7
    Metabolism and nutrition disorders
    ACIDOSIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 422 (0.24%)
         occurrences all number
    1
    1
    ALKALOSIS NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 422 (0.00%)
         occurrences all number
    1
    0
    ANOREXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    114 / 411 (27.74%)
    141 / 422 (33.41%)
         occurrences all number
    210
    328
    BLOOD BICARBONATE DECREASED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    6 / 422 (1.42%)
         occurrences all number
    14
    9
    DEHYDRATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    18 / 411 (4.38%)
    19 / 422 (4.50%)
         occurrences all number
    21
    25
    GLUCOSE TOLERANCE IMPAIRED
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 422 (0.24%)
         occurrences all number
    0
    1
    HYPERCALCAEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    10 / 422 (2.37%)
         occurrences all number
    3
    11
    HYPERGLYCAEMIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    120 / 411 (29.20%)
    128 / 422 (30.33%)
         occurrences all number
    349
    311
    HYPERKALAEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    16 / 411 (3.89%)
    15 / 422 (3.55%)
         occurrences all number
    21
    19
    HYPERMAGNESAEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    2 / 422 (0.47%)
         occurrences all number
    4
    3
    HYPERNATREMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    21 / 411 (5.11%)
    20 / 422 (4.74%)
         occurrences all number
    30
    32
    HYPERTRIGLYCERIDAEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 411 (0.49%)
    1 / 422 (0.24%)
         occurrences all number
    2
    1
    HYPERURICEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 411 (0.97%)
    8 / 422 (1.90%)
         occurrences all number
    7
    15
    HYPOALBUMINEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    45 / 411 (10.95%)
    59 / 422 (13.98%)
         occurrences all number
    83
    115
    HYPOCALCEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    38 / 411 (9.25%)
    44 / 422 (10.43%)
         occurrences all number
    55
    63
    HYPOGLYCEMIA NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    22 / 411 (5.35%)
    21 / 422 (4.98%)
         occurrences all number
    30
    34
    HYPOKALEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    46 / 411 (11.19%)
    55 / 422 (13.03%)
         occurrences all number
    90
    87
    HYPOMAGNESEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    6 / 411 (1.46%)
    4 / 422 (0.95%)
         occurrences all number
    7
    6
    HYPONATREMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    49 / 411 (11.92%)
    61 / 422 (14.45%)
         occurrences all number
    84
    109
    HYPOPHOSPHATAEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 411 (1.70%)
    7 / 422 (1.66%)
         occurrences all number
    12
    13

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

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

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