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    Clinical Trial Results:
    Randomised Phase II study of biweekly versus fractionated triweekly combination Taxotere-Cisplatin-5FU in advanced gastric and gastro-esophageal junction cancer

    Summary
    EudraCT number
    		 2008-000551-10
    Trial protocol
    		 BE  
    Global end of trial date
    07 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Sep 2021
    First version publication date
    11 Sep 2021
    Other versions
    Summary report(s)
    		 Final Report

    Trial information

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    Trial identification
    Sponsor protocol code
    DoGE01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut Jules Bordet
    Sponsor organisation address
    rue Héger Bordet 1, Bruxelles, Belgium, 1000
    Public contact
    Dr. Alain Hendlisz, Institut Jules Bordet, 32 2 541 31 96, alain.hendlisz@bordet.be
    Scientific contact
    Dr. Alain Henlisz, Institut Jules Bordet, 32 2 541 31 96, alain.hendlisz@bordet.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate feasibility (i.e. absence of limiting toxicity –febrile neutropenia- and absence of progression) of a biweekly and a fractionated triweekly regimen of Taxotere-Cisplatin-5-FU in advanced gastric and oesogastric junction cancer.
    Protection of trial subjects
    The responsible investigator will ensure that this study is conducted in agreement with either the Declaration of Helsinki (Tokyo, Venice and Hong Kong amendments), or the laws and regulations of the country, whichever provides the greatest protection of the patient. The protocol has been written, and the study will be conducted according to the guidelines for Good Clinical Practice issued by the European Union The name of the patient will not be asked for or recorded. A sequential trial identification number will be allocated to each patient at registration and this number will be used to identify them and will be used on all case report forms. In order to avoid errors patient initials (maximum 4), date of birth and local hospital will also be recorded on the case report forms.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 106
    Worldwide total number of subjects
    106
    EEA total number of subjects
    106
    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)
    67
    From 65 to 84 years
    38
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between October 2008 and October 2013, 106 patients were recruited in 15 Belgian centers. Both treatment arms were balanced for age, sex, performance status, tumor location, and differentiation. Among the 106 patients included, 103 effectively received the treatment assigned (52 in arm 1 and 51 in arm 2).

    Pre-assignment
    Screening details
    		 The study included a screening/baseline period and a on treatment period.

    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
    		 Arm 1
    Arm description
    		 Fractionated Triweekly Regimen: One cycle is defined as a 3 weeks-period on treatment. All three drugs are administered day 1-day 8 every 3 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    40 mg/m² dose on day 1 and day 8. Premedication with 8mg dexamethasone IV before Docetaxel, then followed by 8 mg orally/day day1-day 3.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    following Docetaxel at 35 mg/m² dose Day 1 and Day 8. Before cisplatin, 20 mg furosemide will be administered.

    Investigational medicinal product name
    5-FluoroUracil (5FU)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    will be administered last. Folinic Acid will be administered in 1 hour infusion at the dose of 400 mg/m² (or 200 mg/m² levogyre form). 5FU will be administered by protracted IV infusion of 1800 mg/m² over 24 hours.

    Arm title
    		 Arm 2
    Arm description
    		 Biweekly regimen: The regimen will be administered every 2 weeks. A cycle is defined as a 2 weeks-period on treatmen
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    50 mg/m² dose. Premedication with 8mg dexamethasone IV before Docetaxel, then followed by 8 mg orally/day day1-day 3.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    following Docetaxel at a 50 mg/m² dose. A bolus of 20 mg furosemide will be administered along with a one hour perfusion of 1 liter saline perfusion (NaCl 09 %) before and after cisplatin.

    Investigational medicinal product name
    Folinic Acid and 5-FluoroUracil (5FU)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    400 mg/m² Folinic Acid IV in 1 hour ( or 200mg/m² Levogyre form) followed by 48 hours perfusion of 2.0 g/m² 5FU

    Number of subjects in period 1
    		Arm 1 Arm 2
    Started
    53
    53
    Completed
    52
    51
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    -
         concurrent illness
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Fractionated Triweekly Regimen: One cycle is defined as a 3 weeks-period on treatment. All three drugs are administered day 1-day 8 every 3 weeks

    Reporting group title
    Arm 2
    Reporting group description
    		 Biweekly regimen: The regimen will be administered every 2 weeks. A cycle is defined as a 2 weeks-period on treatmen

    Reporting group values
    		 Arm 1 Arm 2 Total
    Number of subjects
    		 53 53 106
    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)
    		 37 30 67
        From 65-84 years
    		 15 23 38
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60 ( 10 ) 63 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 14 30
        Male
    		 37 39 76

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Fractionated Triweekly Regimen: One cycle is defined as a 3 weeks-period on treatment. All three drugs are administered day 1-day 8 every 3 weeks

    Reporting group title
    Arm 2
    Reporting group description
    		 Biweekly regimen: The regimen will be administered every 2 weeks. A cycle is defined as a 2 weeks-period on treatmen

    Subject analysis set title
    Treatment received
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Among the 106 patients included, 103 received the assigned treatment (52 in arm 1 and 51 in arm 2): one patient withdrew consent 5 days after inclusion, one developed an intestinal obstruction, and one died of progressive disease on the 13th day after inclusion without receiving any treatment.

    Primary: Rate of non-progressive disease at 6 weeks

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    End point title
    		 Rate of non-progressive disease at 6 weeks [1]
    End point description
    End point type
    Primary
    End point timeframe
    After 6 weeks of treatment: after 2 cycles of treatment in arm 1, after 3 cycles of treatment in arm 2
    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 formal comparison between the two arms were performed, cfr. protocol.
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    53
    53
    Units: percentage
        median (confidence interval 95%)
    83 (71 to 91)
    79 (67 to 88)
    No statistical analyses for this end point

    Secondary: Occurence of at least one episode of febrile neutropenia

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    End point title
    		 Occurence of at least one episode of febrile neutropenia
    End point description
    103 of the 106 patients received treatment: 52 in arm 1 and 51 in arm 2.
    End point type
    Secondary
    End point timeframe
    within the first 6 weeks of treatment: within the first two cycles in arm 1, within the first three cycles in arm 2
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    52
    51
    Units: Episode
    5
    3
    No statistical analyses for this end point

    Secondary: Best Responses

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    End point title
    		 Best Responses
    End point description
    Forty-five patients in each arm had at least 6 weeks of treatment (2 cycles in arm 1 and 3 cycles in arm 2)
    End point type
    Secondary
    End point timeframe
    after at least 6 weeks of treatment
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    45
    45
    Units: Patient
        Complete Response
    2
    2
        Partial Response
    20
    18
        Stable Disease
    16
    16
        Progression
    6
    4
        Non evaluable
    1
    5
    No statistical analyses for this end point

    Secondary: Time to significant event (TTSE)

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    End point title
    		 Time to significant event (TTSE)
    End point description
    End point type
    Secondary
    End point timeframe
    Time to significant event (TTSE) was defined as the time to toxicity greater than grade II, progression, or death, whatever occurred first.
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    53
    53
    Units: months
        median (confidence interval 95%)
    0.51 (0.39 to 1.51)
    0.75 (0.46 to 1.25)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    End point type
    Secondary
    End point timeframe
    since randomization
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    53
    53
    Units: months
        median (confidence interval 95%)
    8.2 (6.0 to 14.5)
    11.9 (7.4 to 15.9)
    Attachments
    		 Untitled (Filename: OS since randomization - in months.JPG)
    No statistical analyses for this end point

    Secondary: Overall survival rate at 6 months

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    End point title
    		 Overall survival rate at 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    at 6 months since randomization
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    53
    53
    Units: percentage
        arithmetic mean (standard deviation)
    63 ( 7 )
    70.5 ( 6.4 )
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    End point type
    Secondary
    End point timeframe
    since randomization
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    53
    53
    Units: months
        median (confidence interval 95%)
    5.1 (3.2 to 6.5)
    5.2 (3.0 to 6.9)
    Attachments
    		 Untitled (Filename: image_2021-08-06_095142.png)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the first administration of study treatments until 30 days after the last dose of study treatments
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 -

    Reporting group title
    Arm 2
    Reporting group description
    		 -

    Serious adverse events
    		 Arm 1 Arm 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 52 (67.31%)
    27 / 51 (52.94%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cytoreductive surgery
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrectomy
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermic chemotherapy
    Additional description: intraperitoneal
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour excision
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 52 (3.85%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 51 (5.88%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    7 / 52 (13.46%)
    4 / 51 (7.84%)
         occurrences causally related to treatment / all
    4 / 7
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 52 (1.92%)
    4 / 51 (7.84%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (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 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         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
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    6 / 52 (11.54%)
    3 / 51 (5.88%)
         occurrences causally related to treatment / all
    6 / 6
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    9 / 52 (17.31%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    9 / 9
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal toxicity
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    4 / 52 (7.69%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    10 / 52 (19.23%)
    4 / 51 (7.84%)
         occurrences causally related to treatment / all
    9 / 11
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic haemorrhage
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         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
    Pruritus
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
    Additional description: Lung infection
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 52 (3.85%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 52 (9.62%)
    5 / 51 (9.80%)
         occurrences causally related to treatment / all
    5 / 6
    4 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cell death
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm 1 Arm 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 52 (100.00%)
    51 / 51 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour haemorrhage
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Embolism
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 51 (1.96%)
         occurrences all number
    2
    1
    Flushing
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Haematoma
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Haemorrhage
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    2 / 52 (3.85%)
    5 / 51 (9.80%)
         occurrences all number
    2
    8
    Vena cava thrombosis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 51 (3.92%)
         occurrences all number
    1
    2
    Chest pain
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Chills
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Fatigue
         subjects affected / exposed
    37 / 52 (71.15%)
    39 / 51 (76.47%)
         occurrences all number
    54
    57
    General physical health deterioration
         subjects affected / exposed
    2 / 52 (3.85%)
    2 / 51 (3.92%)
         occurrences all number
    2
    3
    Influenza like illness
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Mucosal inflammation
         subjects affected / exposed
    6 / 52 (11.54%)
    8 / 51 (15.69%)
         occurrences all number
    7
    10
    Oedema
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    6 / 52 (11.54%)
    5 / 51 (9.80%)
         occurrences all number
    7
    5
    Pain
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 51 (5.88%)
         occurrences all number
    1
    3
    Pyrexia
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 51 (5.88%)
         occurrences all number
    2
    3
    Visceral oedema
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 51 (1.96%)
         occurrences all number
    3
    1
    Reproductive system and breast disorders
    Lung disorder
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Rectocele
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Vaginal prolapse
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 52 (13.46%)
    2 / 51 (3.92%)
         occurrences all number
    7
    2
    Dyspnoea
         subjects affected / exposed
    3 / 52 (5.77%)
    8 / 51 (15.69%)
         occurrences all number
    4
    9
    Epistaxis
         subjects affected / exposed
    4 / 52 (7.69%)
    1 / 51 (1.96%)
         occurrences all number
    4
    2
    Hiccups
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Nasal dryness
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 51 (3.92%)
         occurrences all number
    2
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Insomnia
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 51 (3.92%)
         occurrences all number
    1
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    3
    1
    Amylase increased
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 51 (1.96%)
         occurrences all number
    2
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 51 (5.88%)
         occurrences all number
    3
    3
    Blood creatinine increased
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Creatinine renal clearance increased
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Lipase increased
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Weight decreased
         subjects affected / exposed
    12 / 52 (23.08%)
    17 / 51 (33.33%)
         occurrences all number
    15
    20
    White blood cell count decreased
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Nasal injury
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Rib fracture
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Skin injury
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Atrial fibrillation
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    8 / 52 (15.38%)
    8 / 51 (15.69%)
         occurrences all number
    13
    9
    Dizziness
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Head discomfort
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 51 (1.96%)
         occurrences all number
    4
    1
    Paraesthesia
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    2 / 52 (3.85%)
    2 / 51 (3.92%)
         occurrences all number
    2
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    11 / 52 (21.15%)
    16 / 51 (31.37%)
         occurrences all number
    16
    17
    Radial nerve palsy
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Tremor
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    28 / 52 (53.85%)
    31 / 51 (60.78%)
         occurrences all number
    39
    40
    Febrile neutropenia
         subjects affected / exposed
    3 / 52 (5.77%)
    4 / 51 (7.84%)
         occurrences all number
    3
    4
    Leukopenia
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 51 (5.88%)
         occurrences all number
    2
    4
    Lymphopenia
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Neutropenia
         subjects affected / exposed
    21 / 52 (40.38%)
    35 / 51 (68.63%)
         occurrences all number
    47
    87
    Thrombocytopenia
         subjects affected / exposed
    15 / 52 (28.85%)
    10 / 51 (19.61%)
         occurrences all number
    24
    19
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    2
    Vertigo
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 51 (3.92%)
         occurrences all number
    1
    2
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Blindness
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Cataract
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Diplopia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Lacrimation increased
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 51 (1.96%)
         occurrences all number
    2
    1
    Vision blurred
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 52 (9.62%)
    8 / 51 (15.69%)
         occurrences all number
    9
    11
    Abdominal pain upper
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Aphthous ulcer
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Anal ulcer
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Ascites
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    2
    Constipation
         subjects affected / exposed
    7 / 52 (13.46%)
    12 / 51 (23.53%)
         occurrences all number
    8
    12
    Diarrhoea
         subjects affected / exposed
    33 / 52 (63.46%)
    24 / 51 (47.06%)
         occurrences all number
    63
    38
    Dyspepsia
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 51 (5.88%)
         occurrences all number
    2
    4
    Dry mouth
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    3 / 52 (5.77%)
    9 / 51 (17.65%)
         occurrences all number
    4
    12
    Flatulence
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    2
    9
    Eructation
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Gastric ulcer
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal pain
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Melaena
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    31 / 52 (59.62%)
    28 / 51 (54.90%)
         occurrences all number
    52
    65
    Odynophagia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Oesophageal pain
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Oesophagitis
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Pneumoperitoneum
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    9 / 52 (17.31%)
    17 / 51 (33.33%)
         occurrences all number
    12
    24
    Vomiting
         subjects affected / exposed
    24 / 52 (46.15%)
    21 / 51 (41.18%)
         occurrences all number
    39
    39
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    4 / 52 (7.69%)
    4 / 51 (7.84%)
         occurrences all number
    4
    4
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    14 / 52 (26.92%)
    25 / 51 (49.02%)
         occurrences all number
    14
    25
    Dermatitis acneiform
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Dry skin
         subjects affected / exposed
    2 / 52 (3.85%)
    2 / 51 (3.92%)
         occurrences all number
    3
    2
    Erythema
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Rash erythematous
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Nail toxicity
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Skin reaction
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Bladder discomfort
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Dysuria
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    2
    Renal impairment
         subjects affected / exposed
    5 / 52 (9.62%)
    5 / 51 (9.80%)
         occurrences all number
    6
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 51 (1.96%)
         occurrences all number
    5
    1
    Bone pain
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Groin pain
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Muscular weakness
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 51 (1.96%)
         occurrences all number
    3
    2
    Musculoskeletal stiffness
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Neck pain
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 52 (7.69%)
    3 / 51 (5.88%)
         occurrences all number
    5
    3
    Conjunctivitis
         subjects affected / exposed
    1 / 52 (1.92%)
    4 / 51 (7.84%)
         occurrences all number
    1
    4
    Fungal oesophagitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Herpes zoster
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Infection
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Lip infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal fungal infection
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Oral fungal infection
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Pharyngitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Sepsis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Tonsillitis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    33 / 52 (63.46%)
    21 / 51 (41.18%)
         occurrences all number
    43
    32
    Dehydration
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    2
    Hypermagnesaemia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    2
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 51 (5.88%)
         occurrences all number
    2
    3
    Hypocalcaemia
         subjects affected / exposed
    4 / 52 (7.69%)
    2 / 51 (3.92%)
         occurrences all number
    6
    2
    Hypokalaemia
         subjects affected / exposed
    7 / 52 (13.46%)
    3 / 51 (5.88%)
         occurrences all number
    10
    3
    Hypomagnesaemia
         subjects affected / exposed
    8 / 52 (15.38%)
    5 / 51 (9.80%)
         occurrences all number
    11
    8
    Hyponatraemia
         subjects affected / exposed
    2 / 52 (3.85%)
    2 / 51 (3.92%)
         occurrences all number
    4
    2
    Hypophosphataemia
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 51 (1.96%)
         occurrences all number
    5
    1
    Metabolic disorder
         subjects affected / exposed
    7 / 52 (13.46%)
    10 / 51 (19.61%)
         occurrences all number
    8
    13
    Vitamin D deficiency
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1

    More information

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

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

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

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