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    Clinical Trial Results:
    Essai de phase II randomisé multicentrique évaluant l’efficacité d’une chimiothérapie seule ou combinée à l’AMG 102 ou au panitumumab en traitement de première ligne chez des patients atteints d’adénocarcinome œsogastrique localement avancé (non résécable) ou métastatique.

    Summary
    EudraCT number
    		 2009-012797-12
    Trial protocol
    		 FR  
    Global end of trial date
    01 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACCORD 20/0904 - Prodige 17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01443065
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UNICANCER
    Sponsor organisation address
    101 rue de Tolbiac, Paris, France, 75013
    Public contact
    Nourredine AIT-RAHMOUNE, Unicancer, 33 1 71 93 67 04,, n.ait-rahmoune@unicancer.fr
    Scientific contact
    Laure Monard, Unicancer, 33 1 73 79 73 09, l-monard@unicancer.fr
    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
    03 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the progression-free survival rate at 4 months.
    Protection of trial subjects
    This study was conducted in accordance with the Declaration of Helsinki (1964) and subsequent amendments, ICH Good Clinical Practice (GCP) Guidelines (CPMP/ICH/135/95), the European Directive (2001/20/CE) and the applicable local regulatory requirements and laws. Furthermore, independent Ethics Committees reviewed and gave favorable opinions to the study documents, including the initial protocol and all subsequent amendments, and all information and documents provided to subjects/patients. Written informed consent was obtained from all patients prior to enrollment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 162
    Worldwide total number of subjects
    162
    EEA total number of subjects
    162
    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)
    83
    From 65 to 84 years
    77
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Prodige 17 – Accord 20 was designed as a phase II, randomized, multicentric, open, three-arm study in patients with locally advance (unresectable) or metastatic adenocarcinoma of the stomach, oesphagus, or cadia.

    Pre-assignment
    Screening details
    		 The study consisted of a 7-day screening phase to establish patients' eligibility and document baseline measurements, a treatment phase (14-day cycle till disease progression), and a long-term follow-up to monitor the progression-free survival, overall survival, time to progression, overall response rate, tumour control rate, and safety

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 mFOLFOX6
    Arm description
    		 Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg/m² on day 1 every 14 days

    Investigational medicinal product name
    Folinic acid/Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravascular use
    Dosage and administration details
    400 mg/m² (racemate) or 200 mg/m² (L-folinic acid) on day 1 every 14 days

    Investigational medicinal product name
    5-fluoro-uracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m² bolus on day 1 then 2400 mg/m² infusion over 46 h every 14 days.

    Arm title
    		 mFOLFOX6 + panitumumab
    Arm description
    		 Panitumumab (6 mg/kg) IV over 60 min (±15 min) before Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg/m² on day 1 every 14 days

    Investigational medicinal product name
    Folinic acid/Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravascular use
    Dosage and administration details
    400 mg/m² (racemate) or 200 mg/m² (L-folinic acid) on day 1 every 14 days

    Investigational medicinal product name
    5-fluoro-uracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m² bolus on day 1 then 2400 mg/m² infusion over 46 h every 14 days.

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg on day 1 every 14 days

    Arm title
    		 mFOLFOX6 + rilotumumab
    Arm description
    		 Rilotumumab (10 mg/kg) IV over 60 min (±15 min) before Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg/m² on day 1 every 14 days

    Investigational medicinal product name
    Folinic acid/Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravascular use
    Dosage and administration details
    400 mg/m² (racemate) or 200 mg/m² (L-folinic acid) on day 1 every 14 days

    Investigational medicinal product name
    5-fluoro-uracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m² bolus on day 1 then 2400 mg/m² infusion over 46 h every 14 days.

    Investigational medicinal product name
    Rilotumumab
    Investigational medicinal product code
    Other name
    AMG 102
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    10 mg/kg on day 1 every 14 days

    Number of subjects in period 1
    		mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab
    Started
    56
    49
    57
    Completed
    0
    0
    1
    Not completed
    56
    49
    56
         Physician decision
    11
    6
    7
         Patient decision
    3
    4
    5
         Disease progression
    33
    21
    31
         Exceeding the treatment deferral
    1
    -
    -
         Adverse event, non-fatal
    3
    9
    4
         Death
    3
    7
    7
         Surgery
    1
    1
    2
         Radiotherapy
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    mFOLFOX6
    Reporting group description
    		 Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.

    Reporting group title
    mFOLFOX6 + panitumumab
    Reporting group description
    		 Panitumumab (6 mg/kg) IV over 60 min (±15 min) before Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.

    Reporting group title
    mFOLFOX6 + rilotumumab
    Reporting group description
    		 Rilotumumab (10 mg/kg) IV over 60 min (±15 min) before Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.

    Reporting group values
    		 mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab Total
    Number of subjects
    		 56 49 57 162
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 64 (38 to 87) 64 (23 to 83) 65 (32 to 83) -
    Gender categorical
    Units: Subjects
        Female
    		 17 16 20 53
        Male
    		 39 33 37 109
    ECOG
    Units: Subjects
        PS 0
    		 20 16 17 53
        PS 1
    		 36 33 39 108
        Missing
    		 0 0 1 1
    Primary tumour localisation
    Units: Subjects
        Esophagus
    		 12 12 8 32
        Cardia
    		 17 13 19 49
        Stomach
    		 26 24 30 80
        Cardia and Stomach
    		 1 0 0 1
    Disease type
    Units: Subjects
        Locally advanced
    		 3 0 2 5
        Metastatic
    		 53 49 55 157
    Dealy from primary tumour diagnosis to randomisation
    Units: month
        median (full range (min-max))
    		 1.1 (0.3 to 65.8) 1.0 (0.1 to 46.8) 1.1 (0.1 to 55.4) -
    Delay from diagnosis of metastasis to randomisation
    Units: month
        median (full range (min-max))
    		 0.9 (0 to 26.1) 0.7 (0 to 2.8) 0.7 (0 to 29.3) -

    End points

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    End points reporting groups
    Reporting group title
    mFOLFOX6
    Reporting group description
    		 Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.

    Reporting group title
    mFOLFOX6 + panitumumab
    Reporting group description
    		 Panitumumab (6 mg/kg) IV over 60 min (±15 min) before Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.

    Reporting group title
    mFOLFOX6 + rilotumumab
    Reporting group description
    		 Rilotumumab (10 mg/kg) IV over 60 min (±15 min) before Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.

    Primary: 4-month PFS

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    End point title
    		 4-month PFS [1]
    End point description
    Progression-free survival (PFS) was evaluated using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). PFS was defined as the time from randomisation to the date of progression or death from any cause, whichever occurred first. The patients alive without progression were censored at the date of the last tumour evaluation and with a maximum of 4 months.
    End point type
    Primary
    End point timeframe
    4 months.
    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: The 4-month PFS rate was the proportion of patients alive without progression at 4 months. In the experimental arms (mFOLFOX6 + panitumumab and mFOLFOX6 + rilotumumab), the decision limits were set at, at least 26 successes observed in 51 patients (4-month PFS ≥51%) to conclude to efficacy, and more than 26 disease progressions or deaths observed in 51 patients (4-month PFS <51%) to conclude to inefficacy. There were no statistical comparisons between groups.
    End point values
    		 mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab
    Number of subjects analysed
    56
    49
    57
    Units: percent
        median (confidence interval 95%)
    71 (57 to 82)
    63 (48 to 77)
    63 (48 to 75)
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Progression-free survival (PFS) was evaluated using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). PFS was defined as the time from randomisation to the date of progression or death from any cause, whichever occurred first. The patients alive without progression were censored at the date of the last tumour evaluation and with a maximum of 5 years.
    End point type
    Secondary
    End point timeframe
    At baseline then every 8 weeks until disease progression, up to 5 years.
    End point values
    		 mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab
    Number of subjects analysed
    56
    49
    57
    Units: month
        median (confidence interval 95%)
    5.8 (5.2 to 7.3)
    5.2 (3.7 to 7.6)
    7.6 (4.0 to 9.0)
    No statistical analyses for this end point

    Secondary: Time to progression

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    End point title
    		 Time to progression
    End point description
    Time to progression was defined as the time from randomisation to disease progression or death from disease progression. The patients alive without disease progression were censored at the date of last tumour evaluation. The patients who died without disease progression were censored at the date of death irrespective of cause.
    End point type
    Secondary
    End point timeframe
    From randomisation to progression or death from diseaase progression, up to 5 years.
    End point values
    		 mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab
    Number of subjects analysed
    56
    49
    57
    Units: month
        median (confidence interval 95%)
    5.9 (5.3 to 7.3)
    5.2 (3.7 to 7.6)
    7.6 (4.0 to 9.0)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall survival was defined as the time from randomisation to death from any cause. The patients alive were censored at the date of last known status.
    End point type
    Secondary
    End point timeframe
    From randomisation to death, up to 5 years.
    End point values
    		 mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab
    Number of subjects analysed
    56
    49
    57
    Units: month
        median (confidence interval 95%)
    13.1 (8.7 to 16.9)
    8.3 (6.2 to 13.2)
    11.5 (7.9 to 17.1)
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    The objective response rate is the proportion of patients with a complete response or partial response. The patients with symptoms of disease progression were evaluated at the tumour level at time of occurrence of the symptoms.
    End point type
    Secondary
    End point timeframe
    At baseline then every 8 weeks, up to 5 years.
    End point values
    		 mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab
    Number of subjects analysed
    56
    49
    57
    Units: percent
        number (not applicable)
    52
    43
    49
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    		 Duration of response
    End point description
    The duration of response was the time from objective tumour response to the date of relapse or progression.
    End point type
    Secondary
    End point timeframe
    Every 8 weeks, up to 5 years.
    End point values
    		 mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab
    Number of subjects analysed
    56
    49
    57
    Units: percent
        number (not applicable)
    73
    78
    81
    No statistical analyses for this end point

    Secondary: Tumour control rate

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    End point title
    		 Tumour control rate
    End point description
    The tumour control rate is the proportion of patients with an objective response (complete or partial response) or a stable disease. Dead patients without disease progression were censored at the date of death.
    End point type
    Secondary
    End point timeframe
    At baseline then every 8 weeks, up to 5 years.
    End point values
    		 mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab
    Number of subjects analysed
    56
    49
    57
    Units: month
        median (confidence interval 95%)
    5.7 (3.8 to 7.8)
    6.4 (3.8 to 11.3)
    8.0 (3.9 to 10.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion until 30 days after end of treatment (up to 5 years).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    mFOLFOX6
    Reporting group description
    		 Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.

    Reporting group title
    mFOLFOX6 + panitumumab
    Reporting group description
    		 Panitumumab (6 mg/kg) IV over 60 min (±15 min) before Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.

    Reporting group title
    mFOLFOX6 + rilotumumab
    Reporting group description
    		 Rilotumumab (10 mg/kg) IV over 60 min (±15 min) before Oxaliplatin (85 mg/m²) IV over 2h, and simultaneous leucovorin/folinic acid (400 mg/m² [racemic] or 200 mg/m² [L-folinic acid]) IV over 2h, followed by 5-FU (400mg/m²) bolus, then 5-FU (2400 mg/m²) by IV perfusion over 46h every 14 days.

    Serious adverse events
    		 mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 54 (68.52%)
    43 / 48 (89.58%)
    57 / 57 (100.00%)
         number of deaths (all causes)
    54
    48
    57
         number of deaths resulting from adverse events
    4
    11
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplastic meningitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Vascular disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic tumor necrosis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolemic shock
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 54 (1.85%)
    5 / 48 (10.42%)
    6 / 57 (10.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Thrombosis of leg deep venous
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Surgical and medical procedures
    Gastrectomy
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiofrequency ablation
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Anasarca
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    3 / 54 (5.56%)
    3 / 48 (6.25%)
    8 / 57 (14.04%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 3
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema aggravated
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 48 (4.17%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    4 / 54 (7.41%)
    4 / 48 (8.33%)
    4 / 57 (7.02%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Hyperthermia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Unknown cause of death
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Immune system disorders
    Localised skin reaction
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Quincke's edema
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash urticarial
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 48 (6.25%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Specific allergy (drug)
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Distress respiratory
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydropneumothorax
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Interstitial pneumonitis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung fibrosis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumopathy
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alkaline phosphatase increased
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 48 (4.17%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    6 / 54 (11.11%)
    2 / 48 (4.17%)
    3 / 57 (5.26%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin low
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzymes increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Phosphatase alkaline increased
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 48 (4.17%)
    3 / 57 (5.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight loss
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Movement of device from original site
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction acute
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Amnesia transient
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropathy
         subjects affected / exposed
    4 / 54 (7.41%)
    2 / 48 (4.17%)
    6 / 57 (10.53%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurotoxicity
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paresthesia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    4 / 57 (7.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral neuropathy NOS
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    3 / 57 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 48 (2.08%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sensory neuropathy
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 48 (0.00%)
    3 / 57 (5.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient hemiparesis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
         subjects affected / exposed
    1 / 54 (1.85%)
    5 / 48 (10.42%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile aplasia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoglobinaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 48 (4.17%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphocytopenia
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 48 (6.25%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    14 / 54 (25.93%)
    13 / 48 (27.08%)
    16 / 57 (28.07%)
         occurrences causally related to treatment / all
    5 / 19
    2 / 16
    16 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombopenia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Visual field defect
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 48 (2.08%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute pancreatitis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aphagia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites infection
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bowel obstruction
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis, enteritis, and gastroenteritis of presumed infectious origin
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 48 (6.25%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 54 (3.70%)
    6 / 48 (12.50%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 2
    7 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    3 / 54 (5.56%)
    4 / 48 (8.33%)
    4 / 57 (7.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Esophageal stenosis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric pain
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric perforation
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Hematemesis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 48 (8.33%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Melena
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mucositis oral
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 48 (4.17%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea and vomiting
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 48 (4.17%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prolapsed hemorrhoid
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyloric stenosis nos
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subocclusive syndrome
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 48 (2.08%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cytolysis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinemia
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminemia
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Abscesses of skin
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dry skin
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial rash
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Folliculitis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intertrigo
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin fissura
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin xerosis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute renal insufficiency
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephropathy tubular
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal insufficiency
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Diabetes
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc space narrowing
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Ascites infection
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Catheter infection
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 48 (8.33%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Central line infection
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection NOS
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Folliculitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 48 (4.17%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural infection bacterial
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septicemia due to escherichia coli (e. Coli)
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary infection
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 48 (4.17%)
    7 / 57 (12.28%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 48 (4.17%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypernatremia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypocalcemia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalemia
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 48 (8.33%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatremia
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 48 (2.08%)
    3 / 57 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypophosphatemia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 48 (4.17%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 mFOLFOX6 mFOLFOX6 + panitumumab mFOLFOX6 + rilotumumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 54 (98.15%)
    48 / 48 (100.00%)
    57 / 57 (100.00%)
    Investigations
    Bilirubin
         subjects affected / exposed
    1 / 54 (1.85%)
    5 / 48 (10.42%)
    8 / 57 (14.04%)
         occurrences all number
    2
    25
    10
    Alanine aminotransferase
         subjects affected / exposed
    25 / 54 (46.30%)
    18 / 48 (37.50%)
    37 / 57 (64.91%)
         occurrences all number
    74
    44
    165
    Aspartate aminotransferase
         subjects affected / exposed
    30 / 54 (55.56%)
    22 / 48 (45.83%)
    37 / 57 (64.91%)
         occurrences all number
    140
    67
    206
    Alkaline phosphatase
         subjects affected / exposed
    29 / 54 (53.70%)
    28 / 48 (58.33%)
    36 / 57 (63.16%)
         occurrences all number
    150
    110
    199
    Plasma magnesium
         subjects affected / exposed
    4 / 54 (7.41%)
    18 / 48 (37.50%)
    12 / 57 (21.05%)
         occurrences all number
    8
    64
    19
    Plasma calcium
         subjects affected / exposed
    13 / 54 (24.07%)
    21 / 48 (43.75%)
    41 / 57 (71.93%)
         occurrences all number
    41
    57
    210
    Uremia
         subjects affected / exposed
    9 / 54 (16.67%)
    7 / 48 (14.58%)
    12 / 57 (21.05%)
         occurrences all number
    14
    15
    30
    Creatine
         subjects affected / exposed
    6 / 54 (11.11%)
    9 / 48 (18.75%)
    7 / 57 (12.28%)
         occurrences all number
    23
    12
    18
    Gamma-glutamyl transferase
         subjects affected / exposed
    19 / 54 (35.19%)
    22 / 48 (45.83%)
    27 / 57 (47.37%)
         occurrences all number
    99
    96
    93
    Hypoalbuminemia
         subjects affected / exposed
    18 / 54 (33.33%)
    13 / 48 (27.08%)
    23 / 57 (40.35%)
         occurrences all number
    54
    35
    91
    Hyponatremia
         subjects affected / exposed
    10 / 54 (18.52%)
    8 / 48 (16.67%)
    9 / 57 (15.79%)
         occurrences all number
    33
    13
    14
    Hypokalemia
         subjects affected / exposed
    7 / 54 (12.96%)
    11 / 48 (22.92%)
    8 / 57 (14.04%)
         occurrences all number
    11
    14
    10
    Lactate dehydrogenase
         subjects affected / exposed
    6 / 54 (11.11%)
    4 / 48 (8.33%)
    5 / 57 (8.77%)
         occurrences all number
    8
    15
    9
    Hyperglycaemia
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 48 (6.25%)
    6 / 57 (10.53%)
         occurrences all number
    5
    4
    17
    Cardiac disorders
    Venous thromboembolism
         subjects affected / exposed
    5 / 54 (9.26%)
    2 / 48 (4.17%)
    9 / 57 (15.79%)
         occurrences all number
    11
    2
    22
    Nervous system disorders
    Peripheral neuropathy
         subjects affected / exposed
    43 / 54 (79.63%)
    39 / 48 (81.25%)
    49 / 57 (85.96%)
         occurrences all number
    320
    249
    473
    Blood and lymphatic system disorders
    Haemoglobin
         subjects affected / exposed
    49 / 54 (90.74%)
    45 / 48 (93.75%)
    49 / 57 (85.96%)
         occurrences all number
    290
    256
    359
    Leucophils
         subjects affected / exposed
    24 / 54 (44.44%)
    16 / 48 (33.33%)
    26 / 57 (45.61%)
         occurrences all number
    96
    65
    68
    Neutrophils
         subjects affected / exposed
    35 / 54 (64.81%)
    30 / 48 (62.50%)
    38 / 57 (66.67%)
         occurrences all number
    117
    84
    144
    Platelets
         subjects affected / exposed
    27 / 54 (50.00%)
    24 / 48 (50.00%)
    42 / 57 (73.68%)
         occurrences all number
    131
    111
    240
    Lymphocytes
         subjects affected / exposed
    15 / 54 (27.78%)
    11 / 48 (22.92%)
    9 / 57 (15.79%)
         occurrences all number
    51
    53
    17
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    42 / 54 (77.78%)
    39 / 48 (81.25%)
    49 / 57 (85.96%)
         occurrences all number
    187
    153
    268
    Anorexia
         subjects affected / exposed
    23 / 54 (42.59%)
    20 / 48 (41.67%)
    21 / 57 (36.84%)
         occurrences all number
    40
    40
    56
    Weight loss
         subjects affected / exposed
    21 / 54 (38.89%)
    22 / 48 (45.83%)
    17 / 57 (29.82%)
         occurrences all number
    32
    61
    50
    Oedema
         subjects affected / exposed
    5 / 54 (9.26%)
    6 / 48 (12.50%)
    22 / 57 (38.60%)
         occurrences all number
    8
    9
    104
    Fever without neutropenia
         subjects affected / exposed
    6 / 54 (11.11%)
    12 / 48 (25.00%)
    16 / 57 (28.07%)
         occurrences all number
    13
    17
    25
    Dysgeusia
         subjects affected / exposed
    6 / 54 (11.11%)
    8 / 48 (16.67%)
    11 / 57 (19.30%)
         occurrences all number
    16
    28
    39
    Dysphagia
         subjects affected / exposed
    13 / 54 (24.07%)
    10 / 48 (20.83%)
    10 / 57 (17.54%)
         occurrences all number
    28
    22
    24
    Dyspnoea
         subjects affected / exposed
    9 / 54 (16.67%)
    5 / 48 (10.42%)
    7 / 57 (12.28%)
         occurrences all number
    21
    8
    12
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    23 / 54 (42.59%)
    28 / 48 (58.33%)
    28 / 57 (49.12%)
         occurrences all number
    92
    81
    64
    Nausea
         subjects affected / exposed
    32 / 54 (59.26%)
    33 / 48 (68.75%)
    43 / 57 (75.44%)
         occurrences all number
    84
    106
    167
    Vomiting
         subjects affected / exposed
    17 / 54 (31.48%)
    20 / 48 (41.67%)
    26 / 57 (45.61%)
         occurrences all number
    33
    54
    73
    Constipation
         subjects affected / exposed
    16 / 54 (29.63%)
    19 / 48 (39.58%)
    26 / 57 (45.61%)
         occurrences all number
    35
    49
    88
    Mucositis
         subjects affected / exposed
    20 / 54 (37.04%)
    21 / 48 (43.75%)
    17 / 57 (29.82%)
         occurrences all number
    60
    43
    36
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    6 / 54 (11.11%)
    5 / 48 (10.42%)
    8 / 57 (14.04%)
         occurrences all number
    25
    17
    11
    Rash
         subjects affected / exposed
    5 / 54 (9.26%)
    38 / 48 (79.17%)
    15 / 57 (26.32%)
         occurrences all number
    6
    183
    35
    Hand-foot syndrome
         subjects affected / exposed
    7 / 54 (12.96%)
    9 / 48 (18.75%)
    6 / 57 (10.53%)
         occurrences all number
    13
    15
    15
    Paronychia
         subjects affected / exposed
    1 / 54 (1.85%)
    9 / 48 (18.75%)
    1 / 57 (1.75%)
         occurrences all number
    2
    19
    1
    Infections and infestations
    Febrile neutropenia
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 48 (6.25%)
    1 / 57 (1.75%)
         occurrences all number
    0
    3
    1
    Infection without neutropenia
         subjects affected / exposed
    3 / 54 (5.56%)
    4 / 48 (8.33%)
    6 / 57 (10.53%)
         occurrences all number
    5
    4
    8
    Blood phosphorus
         subjects affected / exposed
    5 / 54 (9.26%)
    17 / 48 (35.42%)
    15 / 57 (26.32%)
         occurrences all number
    15
    57
    31

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Apr 2011
    The inclusions were suspended from March 2011 till June 2011: UNICANCER was notified by the manufacturer that glass fragments were found in the vials containing rilotumumab (AMG 102). The manufacturer suggested that a filter be used during the administration of the product. At the time of notification, three patients had been included: one patient in Arm AMG 102. UNICANCER decided to suspend inclusions, as well as, the administration of the product to patient N°2 until further information was available.
    17 Jun 2011
    Updated the study documents to include the use of a filter during the administration of rilotumumab.
    11 Sep 2013
    On the 27 May 2013, the independent data committee (IDMC) concluded that the treatment in Arm mFOLFOX6 + panitumumab was possibly not efficacious. Furthermore, more patients died in this Arm compared to Arms mFOLFOX6 and Arm mFOLFOX6 + rilotumumab. The IDMC recommended that inclusions in Arm mFOLFOX6 + panitumumab be stopped. On the 24 June 2013, UNICANCER decided to stop the inclusions in Arm mFOLFOX6 + panitumumab. At this time, 150 patients had been included: 50 patients in Arm mFOLFOX6, 49 in Arm mFOLFOX6 + panitumumab, and 51 in Arm mFOLFOX6 + rilotumumab. The last patient randomized to Arm mFOLFOX6 + panitumumab was on the 24 May 2013.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Mar 2011
    The inclusions were suspended from March 2011 till June 2011: UNICANCER was notified by the manufacturer that glass fragments were found in the vials containing rilotumumab (AMG 102). The manufacturer suggested that a filter be used during the administration of the product. At the time of notification, three patients had been included: one in Arm AMG 102. UNICANCER decided to suspend inclusions, as well as, the administration of the product to this patient until further information was available.
    17 Jun 2011

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    No standard first-line chemotherapy existed for treating advanced gastric cancers; however, platinum-based combination chemotherapy was frequently used. In this study, mFOLFOX6 was selected due to its known activity and acceptable safety profile.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31129386
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