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    Clinical Trial Results:
    A prospective randomised controlled phase III trial of gemcitabine and docetaxel compared with doxorubicin as first line treatment in previously untreated advanced unresectable or metastatic soft tissue sarcomas

    Summary
    EudraCT number
    2009-014907-29
    Trial protocol
    GB  
    Global end of trial date
    08 May 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    21 May 2020
    First version publication date
    21 May 2020
    Other versions
    Summary report(s)
    GeDDiS publication

    Trial information

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    Trial identification
    Sponsor protocol code
    UCL/09/0060
    Additional study identifiers
    ISRCTN number
    ISRCTN07742377
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    UK CTA number: 20363/0285/001-0001, Swiss CTA number: 2013DR3049
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Joint Research Office, Gower Street , London , United Kingdom, WC1E 6BT
    Public contact
    ctc.sponsor@ucl.ac.uk, University College London, 020 76799264, ctc.geddis@ucl.ac.uk
    Scientific contact
    ctc.sponsor@ucl.ac.uk, University College London, 020 76799264, ctc.geddis@ucl.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal research objective is to compare the efficacy and effectiveness of gemcitabine and docetaxel with that of doxorubicin.
    Protection of trial subjects
    The risks for patients in this trial were similar to those for any patient undergoing chemotherapy treatment. The eligibility criteria were stringent to ensure patients were fit enough to receive treatment, assessments during and after trial treatment were comprehensive and detailed guidance was given in the protocol for dose modifications if/when toxicity from the chemotherapy occurred. Adverse events pertaining to the administration of these drugs were closely monitored throughout the trial. Each patient's GP was informed of their participation and asked to report all serious side effects immediately to the research team at site. Patient cards were also issued to the patients in case of emergencies, which contained information about the trial and contact details of the hospital where they were being treated. A risk assessment was performed for this trial and an appropriate level of monitoring was carried out, including the monitoring of patient safety. Safety information was presented to the Trial Management Group, Data Monitoring Committee and Trial Steering Committee on a regular basis.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Nov 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 249
    Country: Number of subjects enrolled
    Switzerland: 8
    Worldwide total number of subjects
    257
    EEA total number of subjects
    249
    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)
    197
    From 65 to 84 years
    60
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    257 patients were recruited in total, 249 within the United Kingdom and 8 in Switzerland. The trial was opened to recruitment on 25/11/2010, the first patient was recruited on 03/12/2010, the final patient was recruited on 20/01/2014.

    Pre-assignment
    Screening details
    497 patients were screened. Patients were excluded due to one of the following reasons: did not meet eligibility criteria, patient decision (declined information sheet, recruitment appointment or randomisation), patient died before enrolment, patient treated at different hospital, clinical decision.

    Period 1
    Period 1 title
    Overall trial (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
    GemcitabineDocetaxel
    Arm description
    Gemcitabine 675 mg/m2 i.v. days 1 and 8, docetaxel 75 mg/m2 i.v. day 8 every three weeks for up to 6 cycles
    Arm type
    Experimental

    Investigational medicinal product name
    gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 675 mg/m2 i.v. days 1 and 8 every three weeks, for up to 6 cycles

    Investigational medicinal product name
    docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel 75 mg/m2 i.v. day 8 every three weeks for up to 6 cycles

    Arm title
    Doxorubicin
    Arm description
    Doxorubicin 75 mg/m2 i.v. day 1 every three weeks for up to 6 cycles
    Arm type
    Active comparator

    Investigational medicinal product name
    doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Doxorubicin 75 mg/m2 i.v. day 1 every three weeks for up to 6 cycles

    Number of subjects in period 1
    GemcitabineDocetaxel Doxorubicin
    Started
    128
    129
    Completed
    49
    71
    Not completed
    79
    58
         did not start treatment
    2
    1
         Physician decision
    5
    4
         Adverse event, serious fatal
    1
    3
         symptomatic deterioration
    3
    4
         death
    3
    2
         Adverse event, non-fatal
    14
    1
         disease progression
    38
    34
         Consent withdrawn by subject
    1
    1
         other reasons/unknown
    11
    7
         intercurrent illness preventing further treatment
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GemcitabineDocetaxel
    Reporting group description
    Gemcitabine 675 mg/m2 i.v. days 1 and 8, docetaxel 75 mg/m2 i.v. day 8 every three weeks for up to 6 cycles

    Reporting group title
    Doxorubicin
    Reporting group description
    Doxorubicin 75 mg/m2 i.v. day 1 every three weeks for up to 6 cycles

    Reporting group values
    GemcitabineDocetaxel Doxorubicin Total
    Number of subjects
    128 129 257
    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)
    98 99 197
        From 65-84 years
    30 30 60
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    77 79 156
        Male
    51 50 101
    WHO performance status
    Units: Subjects
        0 - Fully active
    52 55 107
        1 - Ambulatory (work able)
    67 63 130
        2 - Ambulatory (not work able)
    9 11 20
    Trojani grade
    Units: Subjects
        Grade 2
    34 29 63
        Grade 3
    85 85 170
        Not known
    9 15 24
    Histology
    "Other eligible sarcomas" contained 47 non-uterine leiomyosarcoma (23 gemcitabine & docetaxel, 24 doxorubicin).
    Units: Subjects
        Uterine leiomyosarcoma
    35 36 71
        Synovial sarcoma
    6 5 11
        Pleomorphic sarcoma
    16 16 32
        Other eligible sarcomas
    71 72 143

    End points

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    End points reporting groups
    Reporting group title
    GemcitabineDocetaxel
    Reporting group description
    Gemcitabine 675 mg/m2 i.v. days 1 and 8, docetaxel 75 mg/m2 i.v. day 8 every three weeks for up to 6 cycles

    Reporting group title
    Doxorubicin
    Reporting group description
    Doxorubicin 75 mg/m2 i.v. day 1 every three weeks for up to 6 cycles

    Primary: Progression free survival at 24 weeks

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    End point title
    Progression free survival at 24 weeks
    End point description
    The primary endpoint for the trial was the proportion of patients who were alive and progression free at 24 weeks post-randomisation. The 24 week Kaplan-Meier progression free survival rates are reported for each arm.
    End point type
    Primary
    End point timeframe
    24 weeks after the date of randomisation
    End point values
    GemcitabineDocetaxel Doxorubicin
    Number of subjects analysed
    128
    129
    Units: percentage
        number (confidence interval 95%)
    0.464 (0.375 to 0.548)
    0.463 (0.375 to 0.546)
    Statistical analysis title
    Progression free survival at 24 weeks
    Statistical analysis description
    The sample size was based on a comparison of proportions. As there was censoring before the week 24 time point, Kaplan-Meier rates have been provided and used for the test of proportions in this section. The following are the results if we remove censored patients and perform a standard test of proportions: Doxorubicin: 59/127 progression free - 46.5% (37.7% - 55.2%) Gemcitabine & Docetaxel: 57/123 progression free - 46.3% (37.4% - 55.3%) p=0.99. Conclusions are the same.
    Comparison groups
    GemcitabineDocetaxel v Doxorubicin
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.99 [1]
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.001
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.123
         upper limit
    0.121
    Notes
    [1] - Conclusions are exactly the same if we do a standard test of proportions or using the K-M rates as we have here.

    Secondary: Progression free survival at 12 weeks

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    End point title
    Progression free survival at 12 weeks
    End point description
    The 12 week Kaplan-Meier progression free survival rates are reported for each arm.
    End point type
    Secondary
    End point timeframe
    12 weeks from date of randomisation.
    End point values
    GemcitabineDocetaxel Doxorubicin
    Number of subjects analysed
    128
    129
    Units: percentage
        number (confidence interval 95%)
    0.638 (0.548 to 0.715)
    0.721 (0.635 to 0.790)
    No statistical analyses for this end point

    Secondary: Progression free survival

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    End point title
    Progression free survival
    End point description
    Kaplan-Meier median progression free survival rates are reported for each arm as well as the hazard ratio comparing the two arms.
    End point type
    Secondary
    End point timeframe
    Entire follow up period.
    End point values
    GemcitabineDocetaxel Doxorubicin
    Number of subjects analysed
    128
    129
    Units: weeks
        median (confidence interval 95%)
    23.7 (18.1 to 28.0)
    23.3 (19.6 to 30.4)
    Statistical analysis title
    PFS hazard ratio
    Statistical analysis description
    Hazard ratio comparing PFS curves (Gemcitabine & Docetaxel vs Doxorubicin). The hazard ratio reported is from an unadjusted comparison. After adjusting for histological subtype, the HR was 1·26 (0·97–1·63; p=0·08).
    Comparison groups
    GemcitabineDocetaxel v Doxorubicin
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.06
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.99
         upper limit
    1.65

    Secondary: Overall survival

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    End point title
    Overall survival
    End point description
    The median overall survival Kaplan-Meier estimates are reported for each arm as well as the hazard ratio comparing the two curves.
    End point type
    Secondary
    End point timeframe
    Entire follow up period.
    End point values
    GemcitabineDocetaxel Doxorubicin
    Number of subjects analysed
    128
    129
    Units: weeks
        median (confidence interval 95%)
    67.3 (53.1 to 83.1)
    76.3 (60.0 to 91.3)
    Statistical analysis title
    OS hazard ratio
    Statistical analysis description
    Hazard ratio comparing OS curves (Gemcitabine & Docetaxel vs Doxorubicin). The hazard ratio reported is from an unadjusted comparison.
    Comparison groups
    GemcitabineDocetaxel v Doxorubicin
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.41
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.83
         upper limit
    1.57

    Secondary: Objective response by RECIST 1.1

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    End point title
    Objective response by RECIST 1.1
    End point description
    End point type
    Secondary
    End point timeframe
    Patients were assessed at 12 weeks post-randomisation, 24 weeks post-randomisation and then approximately every 12 weeks until disease progression or 24 months post-randomisation.
    End point values
    GemcitabineDocetaxel Doxorubicin
    Number of subjects analysed
    128
    129
    Units: patients
        Complete Response (CR)
    0
    2
        Partial Response (PR)
    25
    23
        Stable Disease (SD)
    50
    60
        Progressive Disease (PD)
    27
    25
        Not Evaluable
    26
    19
    No statistical analyses for this end point

    Secondary: Quality of life at 12 weeks

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    End point title
    Quality of life at 12 weeks
    End point description
    Here we report details of the difference between treatment arms in Global Health Status score at 12 weeks. Further details of differences in quality of life at 12 weeks were reported in the main trial paper. There was no evidence to suggest that quality of life measures differed between the two treatment groups.
    End point type
    Secondary
    End point timeframe
    12 weeks post-randomisation.
    End point values
    GemcitabineDocetaxel Doxorubicin
    Number of subjects analysed
    63
    64
    Units: score
        arithmetic mean (standard deviation)
    59.1 ± 21.8
    63.8 ± 22.5
    Statistical analysis title
    Difference in mean Global Health Status score
    Statistical analysis description
    From a linear regression model, adjusting for baseline score, histological subtype, and time since baseline. Treatment effect is calculated as: (gemcitabine and docetaxel change from baseline) – (doxorubicin change from baseline).
    Comparison groups
    GemcitabineDocetaxel v Doxorubicin
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.17
    Method
    Regression, Linear
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15
         upper limit
    4.7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (including serious adverse events) that occurred between informed consent and 30 days post last trial treatment administration were recorded.
    Adverse event reporting additional description
    Adverse events pertaining to the trial drugs were closely monitored throughout the trial. Each patients GP was informed of their participation and asked to report all serious side effects immediately to sites. Patient contact cards and adverse event diaries were also issued to patients and reviewed before each treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    GemcitabineDocetaxel
    Reporting group description
    Gemcitabine 675 mg/m2 i.v. days 1 and 8, docetaxel 75 mg/m2 i.v. day 8 every three weeks for up to 6 cycles

    Reporting group title
    Doxorubicin
    Reporting group description
    Doxorubicin 75 mg/m2 i.v. day 1 every three weeks for up to 6 cycles

    Serious adverse events
    GemcitabineDocetaxel Doxorubicin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    71 / 126 (56.35%)
    69 / 128 (53.91%)
         number of deaths (all causes)
    80
    74
         number of deaths resulting from adverse events
    3
    3
    Vascular disorders
    Hot flashes
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thromboembolic event
         subjects affected / exposed
    4 / 126 (3.17%)
    9 / 128 (7.03%)
         occurrences causally related to treatment / all
    1 / 4
    5 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Bronchial infection
         subjects affected / exposed
    2 / 126 (1.59%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema limbs
         subjects affected / exposed
    2 / 126 (1.59%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    15 / 126 (11.90%)
    14 / 128 (10.94%)
         occurrences causally related to treatment / all
    10 / 19
    13 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 126 (1.59%)
    4 / 128 (3.13%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death NOS
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Psychiatric disorders
    Confusion
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Female genital tract fistula
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic pain
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    10 / 126 (7.94%)
    18 / 128 (14.06%)
         occurrences causally related to treatment / all
    10 / 10
    22 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Chest pain - cardiac
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart failure
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular systolic dysfunction
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Palpitations
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 126 (3.17%)
    6 / 128 (4.69%)
         occurrences causally related to treatment / all
    4 / 4
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    15 / 126 (11.90%)
    26 / 128 (20.31%)
         occurrences causally related to treatment / all
    14 / 15
    26 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    5 / 126 (3.97%)
    3 / 128 (2.34%)
         occurrences causally related to treatment / all
    0 / 5
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 126 (3.17%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bloating
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic ulcer
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 126 (0.79%)
    4 / 128 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    9 / 126 (7.14%)
    5 / 128 (3.91%)
         occurrences causally related to treatment / all
    7 / 9
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 126 (1.59%)
    4 / 128 (3.13%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    5 / 126 (3.97%)
    3 / 128 (2.34%)
         occurrences causally related to treatment / all
    2 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin reaction
    Additional description: reaction at Hickman line site
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulceration
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anorectal infection
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter related infection
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    2 / 126 (1.59%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
    Additional description: Hickman line infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella zoster virus infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    5 / 126 (3.97%)
    5 / 128 (3.91%)
         occurrences causally related to treatment / all
    2 / 5
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nail infection
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Cellulitis
         subjects affected / exposed
    2 / 126 (1.59%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    2 / 126 (1.59%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory infection
         subjects affected / exposed
    3 / 126 (2.38%)
    3 / 128 (2.34%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 126 (1.59%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    GemcitabineDocetaxel Doxorubicin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    126 / 126 (100.00%)
    128 / 128 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 128 (1.56%)
         occurrences all number
    1
    2
    Thromboembolic event
         subjects affected / exposed
    4 / 126 (3.17%)
    8 / 128 (6.25%)
         occurrences all number
    4
    8
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    3 / 126 (2.38%)
    2 / 128 (1.56%)
         occurrences all number
    3
    2
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    4 / 126 (3.17%)
    1 / 128 (0.78%)
         occurrences all number
    4
    1
    Anaphylaxis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    108 / 126 (85.71%)
    116 / 128 (90.63%)
         occurrences all number
    108
    116
    Pain
         subjects affected / exposed
    79 / 126 (62.70%)
    80 / 128 (62.50%)
         occurrences all number
    79
    80
    Fever
         subjects affected / exposed
    28 / 126 (22.22%)
    25 / 128 (19.53%)
         occurrences all number
    28
    25
    Oedema limbs
         subjects affected / exposed
    55 / 126 (43.65%)
    24 / 128 (18.75%)
         occurrences all number
    55
    24
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 126 (1.59%)
    1 / 128 (0.78%)
         occurrences all number
    2
    1
    Infusion related reaction
         subjects affected / exposed
    5 / 126 (3.97%)
    0 / 128 (0.00%)
         occurrences all number
    5
    0
    Sudden death NOS
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    10 / 126 (7.94%)
    10 / 128 (7.81%)
         occurrences all number
    10
    10
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Premature menopause
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Vascular access complication
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 128 (1.56%)
         occurrences all number
    1
    2
    Fracture
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Radiation recall reaction (dermatologic)
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Investigations
    White blood cell decreased
         subjects affected / exposed
    63 / 126 (50.00%)
    43 / 128 (33.59%)
         occurrences all number
    63
    43
    Neutrophil count decreased
         subjects affected / exposed
    71 / 126 (56.35%)
    58 / 128 (45.31%)
         occurrences all number
    71
    58
    Platelet count decreased
         subjects affected / exposed
    31 / 126 (24.60%)
    14 / 128 (10.94%)
         occurrences all number
    31
    14
    Alkaline phosphatase increased
         subjects affected / exposed
    48 / 126 (38.10%)
    43 / 128 (33.59%)
         occurrences all number
    48
    43
    Alanine aminotransferase increased
         subjects affected / exposed
    37 / 126 (29.37%)
    35 / 128 (27.34%)
         occurrences all number
    37
    35
    Aspartate aminotransferase increased
         subjects affected / exposed
    13 / 126 (10.32%)
    14 / 128 (10.94%)
         occurrences all number
    13
    14
    GGT increased
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Urea increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    12 / 126 (9.52%)
    11 / 128 (8.59%)
         occurrences all number
    12
    11
    Blood creatinine decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Cardiac disorders
    Chest pain - cardiac
         subjects affected / exposed
    2 / 126 (1.59%)
    1 / 128 (0.78%)
         occurrences all number
    2
    1
    Heart failure
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Left ventricular systolic dysfunction
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Myocardial infarction
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 128 (0.78%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    112 / 126 (88.89%)
    101 / 128 (78.91%)
         occurrences all number
    112
    101
    Febrile neutropenia
         subjects affected / exposed
    15 / 126 (11.90%)
    26 / 128 (20.31%)
         occurrences all number
    15
    26
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    26 / 126 (20.63%)
    24 / 128 (18.75%)
         occurrences all number
    26
    24
    Dyspnoea
         subjects affected / exposed
    29 / 126 (23.02%)
    19 / 128 (14.84%)
         occurrences all number
    29
    19
    Pneumonitis
         subjects affected / exposed
    8 / 126 (6.35%)
    4 / 128 (3.13%)
         occurrences all number
    8
    4
    Epistaxis
         subjects affected / exposed
    13 / 126 (10.32%)
    2 / 128 (1.56%)
         occurrences all number
    13
    2
    Hiccups
         subjects affected / exposed
    3 / 126 (2.38%)
    2 / 128 (1.56%)
         occurrences all number
    3
    2
    Pleural effusion
         subjects affected / exposed
    2 / 126 (1.59%)
    1 / 128 (0.78%)
         occurrences all number
    2
    1
    Bronchopulmonary haemorrhage
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Pneumothorax
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    25 / 126 (19.84%)
    24 / 128 (18.75%)
         occurrences all number
    25
    24
    Peripheral sensory neuropathy
         subjects affected / exposed
    31 / 126 (24.60%)
    14 / 128 (10.94%)
         occurrences all number
    31
    14
    Dizziness
         subjects affected / exposed
    4 / 126 (3.17%)
    10 / 128 (7.81%)
         occurrences all number
    4
    10
    Syncope
         subjects affected / exposed
    0 / 126 (0.00%)
    3 / 128 (2.34%)
         occurrences all number
    0
    3
    Tremor
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    72 / 126 (57.14%)
    87 / 128 (67.97%)
         occurrences all number
    72
    87
    Mucositis oral
         subjects affected / exposed
    61 / 126 (48.41%)
    82 / 128 (64.06%)
         occurrences all number
    61
    82
    Constipation
         subjects affected / exposed
    51 / 126 (40.48%)
    55 / 128 (42.97%)
         occurrences all number
    51
    55
    Diarrhoea
         subjects affected / exposed
    52 / 126 (41.27%)
    50 / 128 (39.06%)
         occurrences all number
    52
    50
    Vomiting
         subjects affected / exposed
    32 / 126 (25.40%)
    49 / 128 (38.28%)
         occurrences all number
    32
    49
    Dyspepsia
         subjects affected / exposed
    18 / 126 (14.29%)
    28 / 128 (21.88%)
         occurrences all number
    18
    28
    Abdominal pain
         subjects affected / exposed
    16 / 126 (12.70%)
    20 / 128 (15.63%)
         occurrences all number
    16
    20
    Dry mouth
         subjects affected / exposed
    5 / 126 (3.97%)
    12 / 128 (9.38%)
         occurrences all number
    5
    12
    Rectal haemorrhage
         subjects affected / exposed
    3 / 126 (2.38%)
    1 / 128 (0.78%)
         occurrences all number
    3
    1
    Colonic ulcer
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Abdominal distension
         subjects affected / exposed
    5 / 126 (3.97%)
    0 / 128 (0.00%)
         occurrences all number
    5
    0
    Ascites
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Diverticulitis
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Rectal tenesmus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Intestinal perforation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Renal vein thrombosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    95 / 126 (75.40%)
    110 / 128 (85.94%)
         occurrences all number
    95
    110
    Urticaria
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 128 (0.78%)
         occurrences all number
    1
    1
    Skin ulceration
         subjects affected / exposed
    3 / 126 (2.38%)
    0 / 128 (0.00%)
         occurrences all number
    3
    0
    Rash
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    16 / 126 (12.70%)
    3 / 128 (2.34%)
         occurrences all number
    16
    3
    Lichen sclerosus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Night sweats
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    12 / 126 (9.52%)
    12 / 128 (9.38%)
         occurrences all number
    12
    12
    Myalgia
         subjects affected / exposed
    12 / 126 (9.52%)
    5 / 128 (3.91%)
         occurrences all number
    12
    5
    Muscle weakness lower limb
         subjects affected / exposed
    2 / 126 (1.59%)
    2 / 128 (1.56%)
         occurrences all number
    2
    2
    Bone pain
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    56 / 126 (44.44%)
    63 / 128 (49.22%)
         occurrences all number
    56
    63
    Hypoalbuminaemia
         subjects affected / exposed
    40 / 126 (31.75%)
    28 / 128 (21.88%)
         occurrences all number
    40
    28
    Hyponatraemia
         subjects affected / exposed
    25 / 126 (19.84%)
    20 / 128 (15.63%)
         occurrences all number
    25
    20
    Hyperkalaemia
         subjects affected / exposed
    18 / 126 (14.29%)
    11 / 128 (8.59%)
         occurrences all number
    18
    11
    Hypokalaemia
         subjects affected / exposed
    8 / 126 (6.35%)
    9 / 128 (7.03%)
         occurrences all number
    8
    9
    Hyperglycaemia
         subjects affected / exposed
    3 / 126 (2.38%)
    1 / 128 (0.78%)
         occurrences all number
    3
    1
    Hypercalcaemia
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Electrolyte imbalance
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Fluid retention
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    8 / 126 (6.35%)
    9 / 128 (7.03%)
         occurrences all number
    8
    9
    Lower respiratory tract infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    6 / 126 (4.76%)
    4 / 128 (3.13%)
         occurrences all number
    6
    4
    Varicella zoster virus infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    0 / 126 (0.00%)
    3 / 128 (2.34%)
         occurrences all number
    0
    3
    Nail infection
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 128 (1.56%)
         occurrences all number
    1
    2
    Lung infection
         subjects affected / exposed
    4 / 126 (3.17%)
    5 / 128 (3.91%)
         occurrences all number
    4
    5
    Upper respiratory infection
         subjects affected / exposed
    2 / 126 (1.59%)
    2 / 128 (1.56%)
         occurrences all number
    2
    2
    Infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    3 / 126 (2.38%)
    1 / 128 (0.78%)
         occurrences all number
    3
    1
    Skin infection
         subjects affected / exposed
    2 / 126 (1.59%)
    1 / 128 (0.78%)
         occurrences all number
    2
    1
    Wound infection
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 128 (0.78%)
         occurrences all number
    1
    1
    Device related infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    4 / 126 (3.17%)
    0 / 128 (0.00%)
         occurrences all number
    4
    0
    Bronchial infection
         subjects affected / exposed
    3 / 126 (2.38%)
    0 / 128 (0.00%)
         occurrences all number
    3
    0
    Catheter related infection
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Escherichia infection
    alternative dictionary used: MedDRA 21
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0
    Sepsis
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 128 (1.56%)
         occurrences all number
    1
    2
    Anal abscess
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 128 (0.78%)
         occurrences all number
    0
    1
    Stoma site abscess
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 128 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Apr 2011
    Protocol: Update on contraception requirements Clarification on dose modifications for haematological toxicity PIS: Clarification of timepoints for CT/MRI scans, and radiation risk to patients Clarification that consent to allow genetic testing on research blood & tissue samples is optional
    21 Oct 2011
    Protocol - Inclusion criteria: Histological confirmation wording changed to clarify high grade disease Chemotherapy wording changed to clarify no previous chemotherapy for sarcoma and no doxorubicin for any previous cancer ALP wording clarified
    08 Mar 2013
    Protocol: Addition of secondary endpoint (Time from start of treatment to progression or death (whichever occurs first))
    23 Mar 2016
    Protocol: Addition of guidance to allow patients who have not progressed after 24 months on trial be scanned according to local site practice
    25 Jan 2019
    Protocol: Translational Research section updated to include information on some additional exploratory research that is planned to be performed on the stored blood and tissue samples

    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.
    Non-serious AEs: includes SAEs and non-serious AEs Non-serious AEs: highest grade experienced by patients collected, therefore 'subjects affected' number has been entered in 'occurrences'

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/28882536
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