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    Clinical Trial Results:
    TRUSTS: A phase IIb/III multicenter study comparing the efficacy of TRabectedin administered as a 3-hour or 24-hour infusion to doxorubicin in patients with advanced or metastatic Untreated Soft Tissue Sarcoma

    Summary
    EudraCT number
    		 2009-014889-26
    Trial protocol
    		 GB   DE   BE   HU   DK   AT   NL   SK   ES   PL  
    Global end of trial date
    16 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 May 2017
    First version publication date
    04 May 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EORTC 62091
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01189253
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    European Organisation for Research and Treatment of Cancer
    Sponsor organisation address
    Avenue E. Mounier 83/11, Brussels, Belgium, 1200
    Public contact
    Project, Budget and Regulatory Dept, European Organisation for Research and Treatment of Cancer, +32 27441062, regulatory@eortc.be
    Scientific contact
    Project, Budget and Regulatory Dept, European Organisation for Research and Treatment of Cancer, +32 27441062, regulatory@eortc.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal objective of the trial is to evaluate whether trabectedin given as 1st line chemotherapy for advanced / metastatic soft tissue sarcoma prolongs progression free survival, as compared to doxorubicin.
    Protection of trial subjects
    The responsible investigator will ensure that this study is conducted in agreement with either the Declaration of Helsinki (available on the World Medical Association web site (http://www.wma.net)) and/or the laws and regulations of the country, whichever provides the greatest protection of the patient. The protocol has been written, and the study will be conducted according to the ICH Harmonized Tripartite Guideline on Good Clinical Practice. The protocol must be approved by the competent ethics committee(s) as required by the applicable national legislation.
    Background therapy
    		 All patients received dexamethasone or an equivalent 30 minutes before administration of trabectedin.
    Evidence for comparator
    		 Doxorubicin is the most active drug for the systemic treatment of STS. Randomized studies have shown that combination chemotherapy can sometimes provide higher response rates than single agent doxorubicin. However, even if present, this higher objective response rate did not translate into improved overall survival.The EORTC STBSG has already evaluated several new drugs given as second line chemotherapy, but the vast majority of these were found to be inactive, with the exception of agents such as trabectedin or imatinib with activity in defined subtypes of STS.
    Actual start date of recruitment
    06 Jun 2011
    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
    Netherlands: 24
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    France: 66
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    133
    EEA total number of subjects
    112
    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)
    79
    From 65 to 84 years
    54
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 133 (112 by EORTC STBSG and 21 by SARC) patients were registered by 28 institutions (9 countries) between June 2011 and August 2012.

    Pre-assignment
    Screening details
    		 The registration/randomization is one step process.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Trab_3hrs
    Arm description
    		 Trabectedin 3 hrs IV
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trabectedin
    Investigational medicinal product code
    GFI-17027907-AAA-PB-003
    Other name
    YONDELIS
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trabectedin will be administered on day 1 every 3 weeks at the dose of 1.3 mg/m2 body surface area, administered as an intravenous infusion over 3 hours.

    Arm title
    		 Trab_24hrs
    Arm description
    		 Trabectedin 24 hrs IV
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trabectedin
    Investigational medicinal product code
    GFI-17027907-AAA-PB-003
    Other name
    YONDELIS
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trabectedin will be administered on day 1 every 3 weeks at the dose of 1.5 mg/m2 body surface area, administered as an intravenous infusion over 24 hours.

    Arm title
    		 Doxo
    Arm description
    		 Doxorubicin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Doxorubicin will be administered on day 1 every 3 weeks at the dose of 75 mg/m² by IV according to institution guidelines. Doxorubicin will be administered for a maximum of 6 cycles (1 cycle=3weeks).

    Number of subjects in period 1
    		Trab_3hrs Trab_24hrs Doxo
    Started
    47
    43
    43
    Completed
    47
    43
    43
    Period 2
    Period 2 title
    On-study
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Trab_3hrs
    Arm description
    		 Trabectedin 3 hrs IV
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trabectedin
    Investigational medicinal product code
    GFI-17027907-AAA-PB-003
    Other name
    YONDELIS
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trabectedin will be administered on day 1 every 3 weeks at the dose of 1.3 mg/m2 body surface area, administered as an intravenous infusion over 3 hours.

    Arm title
    		 Trab_24hrs
    Arm description
    		 Trabectedin 24 hrs IV
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trabectedin
    Investigational medicinal product code
    GFI-17027907-AAA-PB-003
    Other name
    YONDELIS
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trabectedin will be administered on day 1 every 3 weeks at the dose of 1.5 mg/m2 body surface area, administered as an intravenous infusion over 24 hours.

    Arm title
    		 Doxo
    Arm description
    		 Doxorubicin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Doxorubicin will be administered on day 1 every 3 weeks at the dose of 75 mg/m² by IV according to institution guidelines. Doxorubicin will be administered for a maximum of 6 cycles (1 cycle=3weeks).

    Number of subjects in period 2
    		Trab_3hrs Trab_24hrs Doxo
    Started
    47
    43
    43
    Completed
    0
    0
    21
    Not completed
    47
    43
    22
         Physician decision
    1
    2
    1
         Consent withdrawn by subject
    1
    2
    1
         Adverse event, non-fatal
    7
    8
    1
         Unknown
    1
    -
    1
         Patient still on treatment
    -
    1
    -
         Death not due to toxicity
    2
    1
    1
         Protocol deviation
    1
    2
    3
         Lack of efficacy
    34
    27
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Trab_3hrs
    Reporting group description
    		 Trabectedin 3 hrs IV

    Reporting group title
    Trab_24hrs
    Reporting group description
    		 Trabectedin 24 hrs IV

    Reporting group title
    Doxo
    Reporting group description
    		 Doxorubicin

    Reporting group values
    		 Trab_3hrs Trab_24hrs Doxo Total
    Number of subjects
    		 47 43 43 133
    Age categorical
    Age at randomization (years)
    Units: Subjects
        60 years and over
    		 24 22 23 69
        From 18-59 years
    		 23 21 20 64
    Age continuous
    Age at randomization
    Units: years
        median (full range (min-max))
    		 60 (34 to 84) 60 (23 to 78) 60 (24 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 29 23 25 77
        Male
    		 18 20 18 56
    WHO Performance status
    WHO Performance status
    Units: Subjects
        0=Fully active
    		 25 21 26 72
        1= Able to carry out work of a light nat
    		 22 22 17 61
    Other medical conditions
    Other medical conditions at trial entry
    Units: Subjects
        Yes
    		 37 36 29 102
        No
    		 10 7 14 31
    Site of primary tumor
    Units: Subjects
        Head and Neck
    		 1 0 0 1
        Trunk
    		 1 5 0 6
        Thoracic
    		 7 3 4 14
        Retro-intra abdominal
    		 7 10 12 29
        Lower extremity
    		 10 14 9 33
        Upper extremity
    		 5 3 1 9
        Visceral GU
    		 2 1 2 5
        Visceral GI
    		 1 2 3 6
        Visceral Gynecological
    		 8 4 8 20
        Visceral Breast
    		 0 0 1 1
        Visceral Other
    		 2 0 0 2
        Other
    		 2 1 3 6
        Unknown
    		 1 0 0 1
    Tumor size (cm)
    Units: Subjects
        ≥ 2
    		 6 4 1 11
        2-5
    		 8 9 5 22
        > 5
    		 19 21 29 69
        Unknown
    		 14 9 8 31
    Growth rate
    Units: Subjects
        Rapid
    		 16 12 18 46
        Slow
    		 5 6 4 15
        Unknown
    		 26 25 21 72
    Necrosis
    Units: Subjects
        No
    		 19 15 16 50
        Yes
    		 19 15 20 54
        Unknown
    		 9 13 7 29
    Type of disease at the time of sampling
    Units: Subjects
        Primary
    		 28 32 32 92
        Recurrent
    		 3 2 3 8
        Metastatic
    		 11 9 7 27
        Recurrent and metastatic
    		 4 0 1 5
        Unknown
    		 1 0 0 1
    Tumor type (Local pathology)
    (Local pathology)
    Units: Subjects
        Adipocytic (liposarcoma)
    		 6 11 13 30
        Fibroblastic
    		 5 3 1 9
        So-called fibrohistiocytic tumours
    		 3 3 1 7
        Smooth muscle tumours
    		 18 8 14 40
        Pericytic (perivascular) tumours
    		 0 1 0 1
        Vascular tumours
    		 1 2 0 3
        Chondro-osseous tumours
    		 0 1 1 2
        Tumors of uncertain differentiation
    		 7 7 8 22
        Undifferentiated sarcoma
    		 4 6 5 15
        Other
    		 3 1 0 4
    Tumor type (Review pathology)
    (Review pathology)
    Units: Subjects
        Adipocytic (liposarcoma)
    		 5 7 12 24
        Fibroblastic
    		 3 4 0 7
        So-called fibrohistiocytic tumours
    		 4 6 4 14
        Smooth muscle tumours
    		 11 4 9 24
        Vascular tumours
    		 1 1 0 2
        Chondro-osseous tumours
    		 0 1 0 1
        Tumors of uncertain differentiation
    		 6 5 6 17
        GIST
    		 1 0 0 1
        Undifferentiated sarcoma NOS
    		 3 3 1 7
        Other
    		 5 1 4 10
        Missing
    		 8 11 7 26
    Tumor grade
    (review)
    Units: Subjects
        Low
    		 2 2 2 6
        Intermediate
    		 18 9 18 45
        High
    		 13 12 11 36
        Unknown
    		 14 20 12 46
    BMI
    Body Mass Index
    Units: kg/m²
        median (full range (min-max))
    		 28.8 (16.9 to 48.1) 25.3 (19.7 to 40) 25.8 (18.8 to 46.2) -
    Tumor size
    Units: cm
        median (full range (min-max))
    		 6 (1 to 22) 7.1 (1 to 22.6) 9 (1.4 to 34) -

    End points

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    End points reporting groups
    Reporting group title
    Trab_3hrs
    Reporting group description
    		 Trabectedin 3 hrs IV

    Reporting group title
    Trab_24hrs
    Reporting group description
    		 Trabectedin 24 hrs IV

    Reporting group title
    Doxo
    Reporting group description
    		 Doxorubicin
    Reporting group title
    Trab_3hrs
    Reporting group description
    		 Trabectedin 3 hrs IV

    Reporting group title
    Trab_24hrs
    Reporting group description
    		 Trabectedin 24 hrs IV

    Reporting group title
    Doxo
    Reporting group description
    		 Doxorubicin

    Primary: PFS

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    End point title
    		 PFS
    End point description
    Progression free survival will be censored on the date of the last tumor assessment documenting absence of progression for patients: 1. who are alive and progression free at the time of the analysis 2. who have withdrawn their consent to continue in the study 3. who are lost to follow up 4. in whom documentation of disease progression or death occurs after 2 or more consecutive missed tumor assessments Note that patients will not be censored if, prior to observing progression, they 1. stop protocol treatment, for example due to toxicity or personal preference 2. change therapy and receive a non protocol anti-cancer treatment These patients will continue to be followed for progression.
    End point type
    Primary
    End point timeframe
    Progression free survival will be measured from the date of randomization until the date of objective PD, symptomatic deterioration or death from any cause, whichever happen first. Results are presented for PFS at 30 months.
    End point values
    		 Trab_3hrs Trab_24hrs Doxo
    Number of subjects analysed
    47
    43
    43
    Units: Patient
        No progression
    1
    3
    4
        Progression
    46
    40
    39
    Statistical analysis title
    		 Hazard Ratio Trab_24hrs versus Doxorubicin
    Comparison groups
    Trab_24hrs v Doxo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.317 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.4
    Notes
    [1] - Cox-model for PFS
    [2] - 1-sided p-value
    Statistical analysis title
    		 Hazard Ratio Trab_3hrs versus Doxorubicin
    Comparison groups
    Doxo v Trab_3hrs
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.687 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.71
    Notes
    [3] - 1-sided p-value
    Statistical analysis title
    		 Hazard Ratio Trab_3hrs versus Trab_24hrs
    Comparison groups
    Trab_24hrs v Trab_3hrs
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.88

    Secondary: OS

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    End point title
    		 OS
    End point description
    OS at 42 months
    End point type
    Secondary
    End point timeframe
    Overall survival will be measured from the date of randomization to the date of death; alive patients will be censored at the date of last follow-up.
    End point values
    		 Trab_3hrs Trab_24hrs Doxo
    Number of subjects analysed
    47
    43
    43
    Units: patients
        Dead
    35
    33
    26
        Alive
    12
    10
    17
    Statistical analysis title
    		 Hazard Ratio Trab_24hrs versus Doxorubicin
    Comparison groups
    Doxo v Trab_24hrs
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.892 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 2.32
    Notes
    [4] - 1-sided p-value
    Statistical analysis title
    		 Hazard Ratio Trab_3hrs versus Doxorubicin
    Comparison groups
    Trab_3hrs v Doxo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.921 [5]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 2.4
    Notes
    [5] - 1-sided p-value

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AE will be recorded after each cycle (worst grade per cycle). Hematological and biochemistry AE will be assessed on the basis of at least every 3 weeks blood counts (weekly during the two first cycles for serum chemistry/hematological tests)
    Adverse event reporting additional description
    CRF for AEs contains pre-specified items + additional boxes for all "other" AEs. (AEs reported as "other" 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
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Trab_3hrs
    Reporting group description
    		 Trabectidin 3 hrs IV

    Reporting group title
    Doxo
    Reporting group description
    		 Doxorubicin

    Reporting group title
    Trab_24hrs
    Reporting group description
    		 Trabectidin 24 hrs IV

    Serious adverse events
    		 Trab_3hrs Doxo Trab_24hrs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 46 (47.83%)
    11 / 40 (27.50%)
    17 / 41 (41.46%)
         number of deaths (all causes)
    11
    15
    9
         number of deaths resulting from adverse events
    1
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BLADDER CANCER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    TUMOUR PAIN
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    HYPOTENSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PHLEBITIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CATHETER SITE INFLAMMATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DEATH
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    FATIGUE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MUCOSAL INFLAMMATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PYREXIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SUDDEN DEATH
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LARYNGEAL INFLAMMATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PLEURAL EFFUSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PNEUMOTHORAX
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    2 / 40 (5.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Psychiatric disorders
    ANXIETY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CONFUSIONAL STATE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 40 (5.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ASPARTATE AMINOTRANSFERASE INCREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BLOOD CREATINE PHOSPHOKINASE INCREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CREATININE RENAL CLEARANCE DECREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HEPATIC ENZYME INCREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LIPASE INCREASED
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    HIP FRACTURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SUBDURAL HAEMATOMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    TRANSFUSION REACTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    PERICARDIAL EFFUSION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    CEREBRAL ISCHAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SOMNOLENCE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SYNCOPE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 40 (2.50%)
    3 / 41 (7.32%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    FEBRILE NEUTROPENIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 40 (2.50%)
    3 / 41 (7.32%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LEUKOPENIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    NEUTROPENIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 46 (6.52%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PANCYTOPENIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    MACULAR OEDEMA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RETINAL VEIN THROMBOSIS
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ABDOMINAL PAIN UPPER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CONSTIPATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DIARRHOEA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DYSPEPSIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    GASTRIC ULCER HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    GASTROINTESTINAL HAEMORRHAGE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    NAUSEA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    4 / 46 (8.70%)
    0 / 40 (0.00%)
    5 / 41 (12.20%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VOMITING
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    4 / 46 (8.70%)
    1 / 40 (2.50%)
    4 / 41 (9.76%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 1
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    DRUG-INDUCED LIVER INJURY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HEPATOCELLULAR INJURY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 40 (5.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    HAEMATURIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RENAL FAILURE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URETERIC OBSTRUCTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT OBSTRUCTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    MUSCULOSKELETAL PAIN
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    BACTERAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BACTERIAL INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BURKHOLDERIA CEPACIA COMPLEX INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DEVICE RELATED INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HERPES ZOSTER
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LUNG INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PYELONEPHRITIS ACUTE
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SEPTIC SHOCK
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    STAPHYLOCOCCAL INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    STAPHYLOCOCCAL SKIN INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 40 (5.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HYPERKALAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HYPOGLYCAEMIA
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Trab_3hrs Doxo Trab_24hrs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 46 (97.83%)
    38 / 40 (95.00%)
    41 / 41 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    TUMOR PAIN
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    9 / 46 (19.57%)
    9 / 40 (22.50%)
    14 / 41 (34.15%)
         occurrences all number
    15
    18
    30
    OTHER NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    1
    0
    1
    Vascular disorders
    FLUSHING
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    3
    0
    2
    HYPERTENSION
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    5 / 46 (10.87%)
    1 / 40 (2.50%)
    3 / 41 (7.32%)
         occurrences all number
    8
    1
    9
    HYPOTENSION
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    2
    PHLEBITIS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    5 / 41 (12.20%)
         occurrences all number
    0
    0
    11
    OTHER VASCULAR DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    2
    THROMBOEMBOLIC EVENT
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    3 / 46 (6.52%)
    3 / 40 (7.50%)
    4 / 41 (9.76%)
         occurrences all number
    4
    5
    5
    Surgical and medical procedures
    SURGICAL AND MEDICAL PROCEDURES
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    CHILLS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 40 (7.50%)
    0 / 41 (0.00%)
         occurrences all number
    3
    6
    0
    EDEMA FACE
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    2
    0
    1
    EDEMA TRUNK
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences all number
    1
    1
    0
    EDEMA LIMBS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    11 / 46 (23.91%)
    2 / 40 (5.00%)
    11 / 41 (26.83%)
         occurrences all number
    21
    2
    22
    FATIGUE
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    33 / 46 (71.74%)
    27 / 40 (67.50%)
    30 / 41 (73.17%)
         occurrences all number
    131
    85
    136
    FLU LIKE SYMPTOMS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    3 / 46 (6.52%)
    1 / 40 (2.50%)
    2 / 41 (4.88%)
         occurrences all number
    3
    1
    2
    FEVER
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    13 / 46 (28.26%)
    3 / 40 (7.50%)
    7 / 41 (17.07%)
         occurrences all number
    14
    3
    9
    INJECTION SITE REACTION
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    1
    0
    1
    OTHER GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    4 / 46 (8.70%)
    4 / 40 (10.00%)
    2 / 41 (4.88%)
         occurrences all number
    6
    5
    2
    NON-CARDIAC CHEST PAIN
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 40 (5.00%)
    0 / 41 (0.00%)
         occurrences all number
    5
    2
    0
    PAIN
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    10 / 46 (21.74%)
    6 / 40 (15.00%)
    11 / 41 (26.83%)
         occurrences all number
    23
    8
    27
    Immune system disorders
    IMMUNE SYSTEM DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences all number
    5
    1
    1
    Reproductive system and breast disorders
    REPRODUCTIVE SYSTEM AND BREAST DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    8 / 46 (17.39%)
    7 / 40 (17.50%)
    12 / 41 (29.27%)
         occurrences all number
    23
    10
    17
    DYSPNEA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    17 / 46 (36.96%)
    7 / 40 (17.50%)
    10 / 41 (24.39%)
         occurrences all number
    31
    14
    17
    OTHER RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    9 / 46 (19.57%)
    7 / 40 (17.50%)
    7 / 41 (17.07%)
         occurrences all number
    12
    14
    11
    EPISTAXIS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    1
    PLEURAL EFFUSION
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    4
    0
    2
    PHARYNGOLARYNGEAL PAIN
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    ANXIETY
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 40 (5.00%)
    9 / 41 (21.95%)
         occurrences all number
    2
    2
    12
    DEPRESSION
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 40 (5.00%)
    3 / 41 (7.32%)
         occurrences all number
    3
    6
    12
    INSOMNIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    3 / 46 (6.52%)
    4 / 40 (10.00%)
    6 / 41 (14.63%)
         occurrences all number
    4
    13
    9
    OTHER PSYCHIATRIC DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    2 / 40 (5.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    2
    0
    Investigations
    HEMOGLOBIN INCREASED
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    3
    0
    2
    LYMPHOCYTE COUNT DECREASED
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    17 / 46 (36.96%)
    14 / 40 (35.00%)
    15 / 41 (36.59%)
         occurrences all number
    58
    35
    69
    NEUTROPHIL COUNT DECREASED
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    30 / 46 (65.22%)
    30 / 40 (75.00%)
    28 / 41 (68.29%)
         occurrences all number
    132
    70
    130
    LYMPHOCYTE COUNT INCREASED
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    1
    0
    2
    OTHER INVESTIGATIONS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    6 / 46 (13.04%)
    3 / 40 (7.50%)
    5 / 41 (12.20%)
         occurrences all number
    16
    4
    6
    PLATELET COUNT DECREASED
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    16 / 46 (34.78%)
    9 / 40 (22.50%)
    18 / 41 (43.90%)
         occurrences all number
    65
    18
    70
    WEIGHT GAIN
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 40 (7.50%)
    9 / 41 (21.95%)
         occurrences all number
    11
    3
    41
    WEIGHT LOSS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    7 / 46 (15.22%)
    14 / 40 (35.00%)
    6 / 41 (14.63%)
         occurrences all number
    37
    31
    36
    WHITE BLOOD CELL DECREASED
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    20 / 46 (43.48%)
    25 / 40 (62.50%)
    25 / 41 (60.98%)
         occurrences all number
    103
    59
    110
    Injury, poisoning and procedural complications
    INJURY, POISONING AND PROCEDURAL COMPLICATIONS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    2
    0
    11
    Cardiac disorders
    LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    0
    OTHER CARDIAC DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    5 / 46 (10.87%)
    2 / 40 (5.00%)
    1 / 41 (2.44%)
         occurrences all number
    7
    2
    2
    PALPITATIONS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    6 / 46 (13.04%)
    3 / 40 (7.50%)
    3 / 41 (7.32%)
         occurrences all number
    10
    5
    3
    VENTRICULAR ARRHYTHMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    DIZZINESS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    5
    0
    5
    HEADACHE
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    7 / 46 (15.22%)
    4 / 40 (10.00%)
    10 / 41 (24.39%)
         occurrences all number
    13
    6
    29
    DYSGEUSIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 40 (7.50%)
    4 / 41 (9.76%)
         occurrences all number
    3
    10
    9
    OTHER NERVOUS SYSTEM DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    5 / 46 (10.87%)
    3 / 40 (7.50%)
    2 / 41 (4.88%)
         occurrences all number
    8
    11
    4
    PERIPHERAL MOTOR NEUROPATHY
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0
    0
    PERIPHERAL SENSORY NEUROPATHY
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    3 / 46 (6.52%)
    2 / 40 (5.00%)
    4 / 41 (9.76%)
         occurrences all number
    5
    2
    4
    Blood and lymphatic system disorders
    ANEMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    32 / 46 (69.57%)
    26 / 40 (65.00%)
    32 / 41 (78.05%)
         occurrences all number
    139
    70
    165
    FEBRILE NEUTROPENIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    6 / 46 (13.04%)
    3 / 40 (7.50%)
    5 / 41 (12.20%)
         occurrences all number
    8
    3
    6
    Ear and labyrinth disorders
    EAR AND LABYRINTH DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    5 / 41 (12.20%)
         occurrences all number
    1
    0
    5
    Eye disorders
    EYE DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    4 / 40 (10.00%)
    5 / 41 (12.20%)
         occurrences all number
    13
    7
    16
    Gastrointestinal disorders
    ABDOMINAL DISTENSION
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 40 (2.50%)
    2 / 41 (4.88%)
         occurrences all number
    3
    1
    3
    CONSTIPATION
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    16 / 46 (34.78%)
    13 / 40 (32.50%)
    24 / 41 (58.54%)
         occurrences all number
    42
    19
    76
    DIARRHEA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    9 / 46 (19.57%)
    5 / 40 (12.50%)
    7 / 41 (17.07%)
         occurrences all number
    12
    6
    10
    FLATULENCE
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    2
    GASTROESOPHAGEAL REFLUX DISEASE
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    3 / 46 (6.52%)
    1 / 40 (2.50%)
    3 / 41 (7.32%)
         occurrences all number
    5
    2
    11
    GASTROINTESTINAL PAIN
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    3 / 46 (6.52%)
    5 / 40 (12.50%)
    7 / 41 (17.07%)
         occurrences all number
    4
    5
    11
    MUCOSITIS ORAL
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    4 / 46 (8.70%)
    14 / 40 (35.00%)
    5 / 41 (12.20%)
         occurrences all number
    9
    22
    5
    NAUSEA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    26 / 46 (56.52%)
    18 / 40 (45.00%)
    30 / 41 (73.17%)
         occurrences all number
    72
    45
    168
    OTHER GASTROINTESTINAL DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    7 / 46 (15.22%)
    13 / 40 (32.50%)
    11 / 41 (26.83%)
         occurrences all number
    10
    16
    36
    VOMITING
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    20 / 46 (43.48%)
    8 / 40 (20.00%)
    16 / 41 (39.02%)
         occurrences all number
    41
    11
    89
    Hepatobiliary disorders
    HEPATOBILIARY DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 40 (2.50%)
    4 / 41 (9.76%)
         occurrences all number
    6
    1
    8
    Skin and subcutaneous tissue disorders
    ALOPECIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    21 / 40 (52.50%)
    0 / 41 (0.00%)
         occurrences all number
    13
    85
    0
    DRY SKIN
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 40 (7.50%)
    0 / 41 (0.00%)
         occurrences all number
    5
    5
    0
    OTHER SKIN AND SUBCUTANEOUS TISSUE DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    4 / 40 (10.00%)
    1 / 41 (2.44%)
         occurrences all number
    1
    4
    1
    ERYTHEMA MULTIFORME
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    RASH MACULO-PAPULAR
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    2
    0
    1
    PRURITUS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 40 (5.00%)
    0 / 41 (0.00%)
         occurrences all number
    2
    3
    0
    Renal and urinary disorders
    CYSTITIS NONINFECTIVE
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    0
    HEMATURIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0
    0
    OTHER RENAL AND URINARY DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    6 / 46 (13.04%)
    3 / 40 (7.50%)
    4 / 41 (9.76%)
         occurrences all number
    7
    7
    5
    PROTEINURIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    3
    0
    0
    URINARY FREQUENCY
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    4 / 46 (8.70%)
    3 / 40 (7.50%)
    0 / 41 (0.00%)
         occurrences all number
    4
    5
    0
    Endocrine disorders
    ENDOCRINE DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    4
    0
    15
    BACK PAIN
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 40 (5.00%)
    0 / 41 (0.00%)
         occurrences all number
    4
    2
    0
    BONE PAIN
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    2 / 41 (4.88%)
         occurrences all number
    0
    1
    2
    MYALGIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    7 / 46 (15.22%)
    1 / 40 (2.50%)
    7 / 41 (17.07%)
         occurrences all number
    11
    1
    23
    GENERALIZED MUSCLE WEAKNESS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    6
    0
    2
    OTHER MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    5 / 46 (10.87%)
    1 / 40 (2.50%)
    4 / 41 (9.76%)
         occurrences all number
    9
    1
    5
    Infections and infestations
    INFECTION
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    15 / 46 (32.61%)
    9 / 40 (22.50%)
    7 / 41 (17.07%)
         occurrences all number
    31
    17
    8
    Metabolism and nutrition disorders
    ANOREXIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    8 / 46 (17.39%)
    8 / 40 (20.00%)
    13 / 41 (31.71%)
         occurrences all number
    20
    13
    23
    HYPERCALCEMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    2
    0
    4
    DEHYDRATION
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    3 / 46 (6.52%)
    5 / 40 (12.50%)
    2 / 41 (4.88%)
         occurrences all number
    3
    6
    2
    HYPERGLYCEMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    10 / 46 (21.74%)
    8 / 40 (20.00%)
    4 / 41 (9.76%)
         occurrences all number
    23
    17
    15
    HYPERKALEMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    11 / 46 (23.91%)
    2 / 40 (5.00%)
    8 / 41 (19.51%)
         occurrences all number
    14
    2
    14
    HYPERNATREMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    5 / 46 (10.87%)
    1 / 40 (2.50%)
    3 / 41 (7.32%)
         occurrences all number
    7
    1
    5
    HYPOALBUMINEMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    13 / 46 (28.26%)
    5 / 40 (12.50%)
    10 / 41 (24.39%)
         occurrences all number
    46
    9
    26
    HYPOGLYCEMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    4 / 46 (8.70%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences all number
    4
    2
    0
    HYPOCALCEMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    8 / 46 (17.39%)
    4 / 40 (10.00%)
    7 / 41 (17.07%)
         occurrences all number
    18
    5
    20
    HYPOKALEMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    9 / 46 (19.57%)
    5 / 40 (12.50%)
    7 / 41 (17.07%)
         occurrences all number
    14
    12
    11
    HYPONATREMIA
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    8 / 46 (17.39%)
    5 / 40 (12.50%)
    2 / 41 (4.88%)
         occurrences all number
    15
    8
    3
    OTHER METABOLISM AND NUTRITION DISORDERS
    alternative dictionary used: CTC 4.0
         subjects affected / exposed
    5 / 46 (10.87%)
    4 / 40 (10.00%)
    5 / 41 (12.20%)
         occurrences all number
    9
    17
    29

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Feb 2011
    Changes in the main criteria for inclusion. Additional information on Trabectidin -Metabolism and elimination - Safety data - Treatment schedule modifications: CPK elevation - impact on other medication Precision of Clinical evaluation, laboratory tests and follow-up

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    04 Jul 2013
    Following an IDMC (04/07/2013), it has been decided to close this study (phase II) and not proceed to the phase III part, as none of the experimental arms provided any real benefit compared to the standard.
    -

    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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