Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomised Phase II trial of Epirubicin, Oxaliplatin and Capecitebine (EOX) versus Docetaxel and Oxaliplatin (EITax) in the treatment of Advanced Gastro-oesophageal cancer - The ELECT trial

    Summary
    EudraCT number
    		 2006-003332-29
    Trial protocol
    		 IE   GB  
    Global end of trial date
    08 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Apr 2021
    First version publication date
    07 Apr 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ICORG 06-05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01710592
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cancer Trials Ireland
    Sponsor organisation address
    Innovation House, Old Finglas Road, Dublin 11, Ireland, D11 KXN4
    Public contact
    Clinical Project Manager, Cancer Trials Ireland, 353 016677211, info@cancertrials.ie
    Scientific contact
    Clinical Project Manager, Cancer Trials Ireland, 353 016677211, info@cancertrials.ie
    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
    27 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to determine in a randomised study if the response rate to docetaxel and oxaliplatin (ElTax) is comparable to epirubicin, oxaliplatin and capecitabine (EOX) and warrants further evaluation in advanced gastro-oesophageal cancer.
    Protection of trial subjects
    This clinical study was designed, implemented, and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations SI 190 of 2004 as amend and European Directive 2001/20/EC. The study was approved by the HPRA and SJH/AMNCH Research Ethics Committee.
    Background therapy
    		 -
    Evidence for comparator
    		 The comparator used in the trial was standard chemotherapy combination of epirubicin, oxaliplatin, and capecitabine (EOX) in the treatment of advanced gastro-oesophageal cancer. The study was to determine if the study research treatment, a combination of docetaxel and oxaliplatin (EITax), had a comparable response rate to the comparator (EOX), and to determine if it (EITax) warrants further evaluation in advanced gastro-oesophageal cancer.
    Actual start date of recruitment
    11 Sep 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research, Efficacy, Safety
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ireland: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    20
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 There were 35 patients recruited in this study. The first patient was enrolled in 2007 and accrual continued until March 2009, when the last patient was recruited.

    Pre-assignment
    Screening details
    		 The target population were patients with unresectable or metastatic, histologically confirmed adenocarcinoma of the stomach, gastro-oesophageal junction or lower third of the oesophagus with measurable disease on CT scanning who had no previous treatment for the advanced disease and who met all of the inclusion and none of the exclusion criteria.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EOX (Standard Arm)
    Arm description
    		 Participants on this arm will receive Epirubicin, Oxaliplatin and Capecitabine (EOX) . This will be the comparator/standard arm for this study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Epirubicin
    Investigational medicinal product code
    Other name
    Ellence, Pharmorubicin, Epirubicin Ebewe
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Epirubicin 50 mg/m2 bolus injection day 1. Cycle repeated every 3 weeks for a maximum of 8 cycles (= 24 weeks). Commercial stock of all of the study drugs will be used.

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Eloxatin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Oxaliplatin 130 mg/m2 in 250mls of 5% dextrose. i.v. over 2 hours day 1. Cycle repeated every 3 weeks for a maximum of 8 cycles (= 24 weeks). Commercial stock of all of the study drugs will be used.

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capecitabine 625 mg/m2 b.d. orally days 1 – 21. Cycle repeated every 3 weeks for a maximum of 8 cycles (= 24 weeks). Commercial stock of all of the study drugs will be used.

    Arm title
    		 EITax (research arm of the trial)
    Arm description
    		 Participants on this arm will receive Oxaliplatin and Taxotere (EITax) – research arm of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel 20 mg/m2 in 250mls of 5% dextrose. i.v. over 30 minutes days 1, 8 and 15 Cycle repeated every 4 weeks for a maximum of 6 cycles (= 24 weeks). Commercial stock of all of the study drugs will be used.

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Eloxatin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Oxaliplatin 85 mg/ m2 in 250mls of 5% dextrose. i.v. over 2 hours days 1 and 15. Cycle repeated every 4 weeks for a maximum of 6 cycles (= 24 weeks). Commercial stock of all of the study drugs will be used

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dexamethasone 8mg i.v. 30 minutes prior to Docetaxel

    Investigational medicinal product name
    Chlorpheniramine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Chlorpheniramine 10mg i.v. 30 minutes prior to Docetaxel Cycle repeated every 4 weeks for a maximum of 6 cycles (= 24 weeks). Commercial stock of all of the study drugs will be used.

    Investigational medicinal product name
    Ranitidine
    Investigational medicinal product code
    Other name
    Zantac
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ranitidine 50mg i.v. 30 minutes prior to Docetaxel Cycle repeated every 4 weeks for a maximum of 6 cycles (= 24 weeks). Commercial stock of all of the study drugs will be used.

    Number of subjects in period 1
    		EOX (Standard Arm) EITax (research arm of the trial)
    Started
    18
    17
    Completed
    2
    1
    Not completed
    16
    16
         Patient is for chemo break as per PI
    1
    -
         Good response & Frail hense desired chemo holiday
    -
    1
         Interstitial Lung Disease
    -
    1
         Disease Progression
    4
    5
         Patient choice due to toxicites experienced
    1
    -
         Consent withdrawn by subject
    1
    -
         Bloods out of range day 1 cycle 1
    -
    1
         Adverse event, non-fatal
    1
    1
         W/d after 6 cycles-due for surgery to resect mets
    1
    -
         Death
    5
    3
         Neurpathy >= Grade 2
    -
    3
         Unknown
    -
    1
         More than 3 weeks delay of treatment
    1
    -
         Protocol deviation
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    EOX (Standard Arm)
    Reporting group description
    		 Participants on this arm will receive Epirubicin, Oxaliplatin and Capecitabine (EOX) . This will be the comparator/standard arm for this study.

    Reporting group title
    EITax (research arm of the trial)
    Reporting group description
    		 Participants on this arm will receive Oxaliplatin and Taxotere (EITax) – research arm of the study.

    Reporting group values
    		 EOX (Standard Arm) EITax (research arm of the trial) Total
    Number of subjects
    		 18 17 35
    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)
    		 11 9 20
        From 65-84 years
    		 7 8 15
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (33 to 77) 64 (42 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 6 3 9
        Male
    		 12 14 26
    Race
    Units: Subjects
        Caucasian
    		 17 17 34
        North African
    		 1 0 1
    ECOG Performance Status
    0=Fully active, able to carry on all pre-disease performance without restriction. 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g. light house work, office work. 2=Ambulatory and capable of self-care but unable to carry out any work activities up and about more than 50% of waking hours. 3=Capable of only limited self-care, confined to bed or chair more than 50 waking hours. 4=Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair. 5=Dead
    Units: Subjects
        0.
    		 7 5 12
        1.
    		 10 11 21
        2.
    		 1 1 2
        3.
    		 0 0 0
        4.
    		 0 0 0
        5.
    		 0 0 0
    Tumor Stage
    Sites of metastasis are Bone, Liver, Lung, Lymph Nodes, Peritoneum, GI, Pancreas, Ovarian Metastases & Periumbilical Soft Tissue
    Units: Subjects
        Distal Metastatic
    		 16 15 31
        Locally Advanced Unresectable
    		 2 2 4
    Baseline Lab Result - Alanine transaminase
    Units: (U/L)
        median (full range (min-max))
    		 14 (5 to 47) 22 (11 to 73) -
    Baseline Lab Result - Absolute neurophil count
    Units: (10to9/L)
        median (full range (min-max))
    		 5.110 (3.35 to 10.80) 5.400 (3.00 to 9.60) -
    Baseline Characteristic - Aspartate transaminase
    Units: U/L
        median (full range (min-max))
    		 19 (14 to 50) 29 (17 to 59) -
    Baseline Lab Result - Bilirubin
    Units: (umol/L)
        median (full range (min-max))
    		 6.50 (3.0 to 16.0) 9.00 (4.0 to 22.0) -
    Baseline Lab Result - Creatinine
    Units: (umol/L)
        median (full range (min-max))
    		 75.50 (37.0 to 112.0) 82.00 (55.0 to 114.0) -
    Baseline Lab Result - Haemoglobin
    Units: g/dl
        median (full range (min-max))
    		 12.450 (8.70 to 15.60) 12.500 (10.60 to 14.3) -
    Baseline Lab Results - Platelets
    Units: (10to9/L)
        median (full range (min-max))
    		 301.00 (173.0 to 550.0) 266.00 (160.00 to 676.00) -
    Baseline Vital Signs - Body Surface Area
    Units: (m^2)
        median (full range (min-max))
    		 1.770 (1.34 to 2.23) 1.890 (1.54 to 2.10) -
    Baseline Vital Sign - Diastolic blood pressure
    Units: (mmHg)
        median (full range (min-max))
    		 73.0 (59 to 90) 76.0 (54 to 91) -
    Baseline Vital Sign - Heart Rate
    Units: Per minute
        median (full range (min-max))
    		 72.5 (55 to 100) 74.0 (62 to 96) -
    Baseline Vital Sign - Height
    Units: cm
        median (full range (min-max))
    		 169.35 (149.8 to 185) 170.00 (158.6 to 182.00) -
    Baseline Vital Sign - Systolic Blood Pressure
    Units: (mmHg)
        median (full range (min-max))
    		 126.0 (97 to 162) 127.0 (98 to 153) -
    Baseline Vital Signs - Weight
    Units: kg
        median (full range (min-max))
    		 65.80 (41.5 to 105.1) 76.60 (53.6 to 94.8) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    EOX (Standard Arm)
    Reporting group description
    		 Participants on this arm will receive Epirubicin, Oxaliplatin and Capecitabine (EOX) . This will be the comparator/standard arm for this study.

    Reporting group title
    EITax (research arm of the trial)
    Reporting group description
    		 Participants on this arm will receive Oxaliplatin and Taxotere (EITax) – research arm of the study.

    Primary: Tumor Response Rate

    		 Close Top of page
    End point title
    		 Tumor Response Rate [1]
    End point description
    The primary objective in this study was to determine and compare the tumour response rate for each treatment. The response is defined as: • Yes = CR or PR sustained for ≥ 4 weeks using the RECIST criteria. • No = Otherwise • Not done = There were 2 individuals who did not receive any treatment and 7 other participants who did not have any RECIST assessments. The Fisher’s exact test was used to compare differences between treatment arms. * otherwise falls into one of the following categories: 1) stable disease, 2)progressive disease, 3) early death from malignant disease, 4) early death from toxicity, 5) early death because of other cause, or 6) unknown (not assessable, insufficient data).
    End point type
    Primary
    End point timeframe
    Tumor response to treatment will be measured radiologically using CT scanning every 12 weeks from the beginning of both treatment arms.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis carried out. Using the Fisher's Exact Test for Count Data it was determined there was no significant differences between the groups (p= 0.3913)
    End point values
    		 EOX (Standard Arm) EITax (research arm of the trial)
    Number of subjects analysed
    18
    17
    Units: No of Subjects
        Not Done
    4
    5
        Yes (CR or PR)
    5
    2
        No
    9
    10
    No statistical analyses for this end point

    Secondary: Progression Free Survival

    		 Close Top of page
    End point title
    		 Progression Free Survival
    End point description
    End point type
    Secondary
    End point timeframe
    Progression free survival was assessed as the time from first treatment to disease progression or death, whichever is reported first (in months). Patients who were lost to follow-up, or who did not progress or die at the time of the data export, were ce
    End point values
    		 EOX (Standard Arm) EITax (research arm of the trial)
    Number of subjects analysed
    18
    17
    Units: Months
        median (confidence interval 95%)
    8.4 (4.3 to 10.1)
    5.3 (2.8 to 8.1)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

    		 Close Top of page
    End point title
    		 Overall Survival (OS)
    End point description
    End point type
    Secondary
    End point timeframe
    Overall survival was assessed as the time from first treatment to death from any cause (in months). Patients who were lost to follow-up, or who were still alive at the time of the data export, were censored at the time they were last known to be alive.
    End point values
    		 EOX (Standard Arm) EITax (research arm of the trial)
    Number of subjects analysed
    18
    17 [2]
    Units: Months
        median (confidence interval 95%)
    12.3 (9.2 to 23.6)
    17.9 (5.8 to 99999)
    Notes
    [2] - The upper bound confidence interval was undetermined for the EITax group (trial treatment).
    No statistical analyses for this end point

    Secondary: Quality of Life

    		 Close Top of page
    End point title
    		 Quality of Life
    End point description
    Due to the much-reduced sample size and the early termination of the study, repeated measures analysis was not carried out.
    End point type
    Secondary
    End point timeframe
    Quality of life was assessed at registration, every 4 weeks during treatment for EITax and every 3 weeks during treatment for EOX, end of treatment, and every 8 weeks thereafter using the EORTC QLQ-OES18 questionnaire.
    End point values
    		 EOX (Standard Arm) EITax (research arm of the trial)
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: QOL Score
    Notes
    [3] - Due to the much-reduced sample size and the early termination of the study, analysis not carried out
    [4] - Due to the much-reduced sample size and the early termination of the study, analysis not carried out
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Oct 2007 - Sept 2015 (8 years)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    EOX (Standard Arm)
    Reporting group description
    		 Participants on this arm will receive Epirubicin, Oxaliplatin and Capecitabine (EOX) . This will be the comparator arm for this study.

    Reporting group title
    EITax (research arm of the trial)
    Reporting group description
    		 Participants on this arm will receive Oxaliplatin and Taxotere (EITax) – research arm of the study.

    Serious adverse events
    		 EOX (Standard Arm) EITax (research arm of the trial)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 18 (66.67%)
    11 / 15 (73.33%)
         number of deaths (all causes)
    10
    8
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood potassium decreased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal nerve dysfunction
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 18 (16.67%)
    4 / 15 (26.67%)
         occurrences causally related to treatment / all
    3 / 5
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 18 (22.22%)
    4 / 15 (26.67%)
         occurrences causally related to treatment / all
    4 / 5
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 18 (16.67%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 18 (11.11%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (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
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 18 (11.11%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EOX (Standard Arm) EITax (research arm of the trial)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 18 (100.00%)
    15 / 15 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Orthostatic Hypotension
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Phlebitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    12 / 18 (66.67%)
    11 / 15 (73.33%)
         occurrences all number
    21
    22
    Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Chest discomfort
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Chest Pain
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Mucosal inflammation
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Oedema Peripheral
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Early Satiety
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Injection site inflammation
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Mucositis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Oedema
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 18 (22.22%)
    6 / 15 (40.00%)
         occurrences all number
    4
    8
    Dyspnoea
         subjects affected / exposed
    5 / 18 (27.78%)
    1 / 15 (6.67%)
         occurrences all number
    5
    1
    Hiccups
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences all number
    3
    2
    Laryngospasm
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Dysphonia
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Epistaxis
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hypoxia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Infection
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Dysaesthesia pharynx
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    4
    Mood Altered
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Depression
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    8 / 18 (44.44%)
    6 / 15 (40.00%)
         occurrences all number
    14
    9
    Aspartate aminotransferase decreased
         subjects affected / exposed
    5 / 18 (27.78%)
    8 / 15 (53.33%)
         occurrences all number
    6
    11
    Platelet count decreased
         subjects affected / exposed
    4 / 18 (22.22%)
    4 / 15 (26.67%)
         occurrences all number
    6
    9
    Neutrophil count decrease
         subjects affected / exposed
    6 / 18 (33.33%)
    0 / 15 (0.00%)
         occurrences all number
    12
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 18 (16.67%)
    5 / 15 (33.33%)
         occurrences all number
    3
    8
    Blood Albumin decreased
         subjects affected / exposed
    3 / 18 (16.67%)
    5 / 15 (33.33%)
         occurrences all number
    3
    7
    Blood Alkaline phosphatase increased
         subjects affected / exposed
    3 / 18 (16.67%)
    4 / 15 (26.67%)
         occurrences all number
    3
    7
    Gamma glutamyltransferase increased
         subjects affected / exposed
    4 / 18 (22.22%)
    5 / 15 (33.33%)
         occurrences all number
    4
    5
    Weight Decrease
         subjects affected / exposed
    5 / 18 (27.78%)
    4 / 15 (26.67%)
         occurrences all number
    5
    4
    Blood bilirubin increase
         subjects affected / exposed
    1 / 18 (5.56%)
    5 / 15 (33.33%)
         occurrences all number
    1
    7
    White Blood Cell Count Decreased
         subjects affected / exposed
    4 / 18 (22.22%)
    2 / 15 (13.33%)
         occurrences all number
    6
    2
    White Blood Cell Count Increased
         subjects affected / exposed
    0 / 18 (0.00%)
    4 / 15 (26.67%)
         occurrences all number
    0
    6
    Blood potassium decreased
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Protein Total Decreased
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 15 (20.00%)
         occurrences all number
    1
    3
    Blood Calcium Decreased
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Blood Creatinine Decreased
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    3
    Blood Magnesium decreased
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    Blood Sodium Decreased
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Neutrophil count increased
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    3
    Blood urea increased
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Blood alkaline phosphatase
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood iron decreased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood lactate dehydrogenase increase
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood phosphorus
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood sodium increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Infusion Related Reactions
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Contusion
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Stoma Site Infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Stoma site Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    4 / 18 (22.22%)
    8 / 15 (53.33%)
         occurrences all number
    13
    17
    Neuropathy peripheral
         subjects affected / exposed
    8 / 18 (44.44%)
    4 / 15 (26.67%)
         occurrences all number
    8
    7
    Paraesthesia
         subjects affected / exposed
    4 / 18 (22.22%)
    0 / 15 (0.00%)
         occurrences all number
    9
    0
    Dysgeusia
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 15 (0.00%)
         occurrences all number
    6
    0
    Headache
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Dizziness
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Dysarthria
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Muscle contractions involuntary
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    5 / 18 (27.78%)
    1 / 15 (6.67%)
         occurrences all number
    17
    1
    Anaemia
         subjects affected / exposed
    5 / 18 (27.78%)
    3 / 15 (20.00%)
         occurrences all number
    8
    4
    Leukopenia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    8
    0
    Thrombocytopenia
         subjects affected / exposed
    3 / 18 (16.67%)
    2 / 15 (13.33%)
         occurrences all number
    5
    2
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Otorrhoea
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 18 (50.00%)
    6 / 15 (40.00%)
         occurrences all number
    25
    14
    Diarrhoaea
         subjects affected / exposed
    8 / 18 (44.44%)
    6 / 15 (40.00%)
         occurrences all number
    20
    10
    Vomiting
         subjects affected / exposed
    4 / 18 (22.22%)
    5 / 15 (33.33%)
         occurrences all number
    7
    9
    Abdominal Pain
         subjects affected / exposed
    5 / 18 (27.78%)
    2 / 15 (13.33%)
         occurrences all number
    8
    5
    Constipation
         subjects affected / exposed
    8 / 18 (44.44%)
    6 / 15 (40.00%)
         occurrences all number
    10
    12
    Dysphagia
         subjects affected / exposed
    2 / 18 (11.11%)
    4 / 15 (26.67%)
         occurrences all number
    2
    6
    Dry Mouth
         subjects affected / exposed
    4 / 18 (22.22%)
    2 / 15 (13.33%)
         occurrences all number
    5
    3
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    3
    Epigastric discomfort
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Abdominal Distension
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Flatulence
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Mouth Haemorrhage
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Odynophagia
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Abdominal Discomfort
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Colitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Defaecation urgency
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Eructation
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Frequent Bowel Movements
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Retching
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Dry Skin
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    4 / 18 (22.22%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    Rash
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Erythema
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nail Disorder
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Skin Reaction
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    2 / 18 (11.11%)
    3 / 15 (20.00%)
         occurrences all number
    2
    3
    Pain in extremity
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Arthralgia
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Flank Pain
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Muscle Spasms
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    trismus
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Joint Stiffness
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Oral Herpes
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Cellulitis
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Clostridium difficile infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Kidney Infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nail Infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Neutropenic Infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Onychomycosis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Sweating fever
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Tooth Infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 18 (44.44%)
    5 / 15 (33.33%)
         occurrences all number
    11
    8
    Hyponatraemia
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 15 (6.67%)
         occurrences all number
    5
    3
    Hypocalcaemia
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 15 (6.67%)
         occurrences all number
    5
    2
    Dehydration
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 15 (6.67%)
         occurrences all number
    5
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    Hypomagnesaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Mar 2007
    Revised Protocol Version 3.1 dated 01Mar2007 - contains additional exclusion criteria requested by the IBM
    08 May 2009
    Amended to version 4.0 dated 29 April 2008 Administrative and typographic corrections to the protocol
    24 Jan 2011
    Amended to Protocol Version 5.0 dated 19 Oct 2010 Was updated to new ICORG SOP format layout changes. Change of CI and site Also included updated, Conmed Information, Contraception Information in Inclusion Criteria and updated PIL to Version 2, dated 21 Aug 2009 Administrative changes throughout the protocol.

    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.
    140 patients were originally planned to be recruited, the study was terminated early due to poor accrual rate, and only 35 patients participated in the study (17 in the EITax group and 18 in the EOX group).
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 13:09:17 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA