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    Clinical Trial Results:
    A Phase III randomized study evaluating gemcitabine and paclitaxel versus gemcitabine alone after FOLFIRINOX failure or intolerance in Metastatic Pancreatic Ductal Adenocarcinoma.

    Summary
    EudraCT number
    		 2018-002886-21
    Trial protocol
    		 FR  
    Global end of trial date
    11 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2025
    First version publication date
    05 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UC-0110/1809
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03943667
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UNICANCER
    Sponsor organisation address
    101 rue de Tolbiac, Paris, France, 75015
    Public contact
    Nourredine AIT RAHMOUNE,, UNICANCER, 33 0171936704, n.ait-rahmoune@unicancer.fr
    Scientific contact
    Nourredine AIT RAHMOUNE,, UNICANCER, 33 0171936704, n.ait-rahmoune@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
    10 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the superiority in terms Overall Survival (OS) of gemcitabine + solvent-based (sb)-paclitaxel over gemcitabine alone in metastatic pancreatic ductal adenocarcinoma after FOLFIRINOX failure or intolerance.
    Protection of trial subjects
    UNICANCER, the trial sponsor, certifies that the trial GEMPAX will be conducted in compliance with the protocol described in this document, and in accordance with the French national regulatory requirements: - Declaration of Helsinki, as modified in 2008, - Loi n°2012-300 du 5 mars 2012 relative aux recherches impliquant la personne humaine, as modified in 2016 - Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) - Loi Informatique et Libertés n°78-17 du 6 janvier 1978 modifiée, relative à la protection des personnes physiques à l'égard des traitements de données à caractère personnel, - Loi n° 2004-800 du 6 août 2004 modifiée, relative à la bioéthique, - Décision du 24 novembre 2006 fixant les règles de Bonnes Pratiques Cliniques pour les recherches biomédicales portant sur des médicaments à usage humain - Arrêté du 24 mai 2006 relatif au contenu et aux modalités de présentation d’un protocole de recherche biomédicale portant sur un médicament à usage humain - Good Manufacturing Practices, in particular, Annex 13 on investigational medicinal products. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the ethics committee (EC) for review and approval. Approval of both the protocol and the consent form will be obtained before any participant is included. Any amendment to the protocol will require review and approval by the EC before the changes are implemented in the study. In addition, all changes to the consent form will be EC-approved. Depending on the consent form modifications a decision will be made whether a new consent is required for patients who have already given consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jun 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 211
    Worldwide total number of subjects
    211
    EEA total number of subjects
    211
    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)
    109
    From 65 to 84 years
    101
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between June 2019 and March 2021, 211 patients were included by 31 French centers.

    Pre-assignment
    Screening details
    		 The study consisted of screening phase to establish patients' eligibility and document baseline measurements,Patients participating in the trial complied for a total number of 12 months after randomization, including an estimate of 6 months of treatment and 6 months of follow-up.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 The patients randomized in this arm received: - Paclitaxel 80 mg/m² in IV infusion over 60 minutes at D1, D8 and D15 followed by 1 week of rest, every 28 days. - Gemcitabine 1000 mg/m² in IV infusion over 30-40 minutes at D1, D8, D15 followed by 1 week of rest, every 28 days. A premedication to prevent hypersensitivity reactions (e.g., dexamethasone, diphenhydramine, H2 blockers) was applied according to the Summary of Products Characteristics. Initial antiemetic prophylaxis was also recommended. Secondary prophylaxis of neutropenia (G-CSF) for weekly chemotherapy was not planned in EORTC recommendations. Center’s practices was applied. Of note, the coordinator of the study was used to prescribe successfully pegylated G-CSF (pegfilgastrim=Neulasta®) on D1 and D15 of each cycle according to other published experience for weekly chemotherapy schedules. At each infusion day, paclitaxel was administered before gemcitabine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The patients received Paclitaxel 80 mg/m² in IV infusion over 60 minutes at D1, D8 and D15 followed by 1 week of rest, every 28 days.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The patients received Gemcitabine 1000 mg/m² in IV infusion over 30-40 minutes at D1, D8, D15 followed by 1 week of rest, every 28 days.

    Arm title
    		 Arm B
    Arm description
    		 The patients randomized in this arm received Gemcitabine 1000 mg/m² in IV infusion over 30-40 minutes at D1, D8, D15 followed by 1 week of rest, every 28 days.
    Arm type
    		 Control groupe

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The patients received Gemcitabine 1000 mg/m² in IV infusion over 30-40 minutes at D1, D8, D15 followed by 1 week of rest, every 28 days.

    Number of subjects in period 1
    		Arm A Arm B
    Started
    140
    71
    Completed
    0
    0
    Not completed
    140
    71
         Consent withdrawn by subject
    1
    -
         Death
    131
    68
         Sponsor decision
    8
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 The patients randomized in this arm received: - Paclitaxel 80 mg/m² in IV infusion over 60 minutes at D1, D8 and D15 followed by 1 week of rest, every 28 days. - Gemcitabine 1000 mg/m² in IV infusion over 30-40 minutes at D1, D8, D15 followed by 1 week of rest, every 28 days. A premedication to prevent hypersensitivity reactions (e.g., dexamethasone, diphenhydramine, H2 blockers) was applied according to the Summary of Products Characteristics. Initial antiemetic prophylaxis was also recommended. Secondary prophylaxis of neutropenia (G-CSF) for weekly chemotherapy was not planned in EORTC recommendations. Center’s practices was applied. Of note, the coordinator of the study was used to prescribe successfully pegylated G-CSF (pegfilgastrim=Neulasta®) on D1 and D15 of each cycle according to other published experience for weekly chemotherapy schedules. At each infusion day, paclitaxel was administered before gemcitabine.

    Reporting group title
    Arm B
    Reporting group description
    		 The patients randomized in this arm received Gemcitabine 1000 mg/m² in IV infusion over 30-40 minutes at D1, D8, D15 followed by 1 week of rest, every 28 days.

    Reporting group values
    		 Arm A Arm B Total
    Number of subjects
    		 140 71 211
    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)
    		 72 37 109
        From 65-84 years
    		 67 34 101
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 65 (39 to 86) 64 (30 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 53 28 81
        Male
    		 87 43 130
    ECOG at baseline
    Units: Subjects
        ECOG 0-1
    		 122 63 185
        ECOG 2
    		 18 8 26
    ECOG PS at baseline
    Units: Subjects
        ECOG PS 0-1
    		 124 63 187
        ECOG PS 2
    		 16 8 24
    PFS duration at first line therapy
    Units: Subjects
        Inferior to 6 months
    		 59 33 92
        Superior or equal to 6 months
    		 81 38 119
    CA 19-9 level at baseline
    Units: Subjects
        Inferior to 59XULN
    		 76 37 113
        Superior or equal to 59XULN
    		 64 34 98
    NLR at baseline
    Units: Subjects
        Inferior to 5
    		 98 49 147
        Superior or equal to 5
    		 42 22 64

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 The patients randomized in this arm received: - Paclitaxel 80 mg/m² in IV infusion over 60 minutes at D1, D8 and D15 followed by 1 week of rest, every 28 days. - Gemcitabine 1000 mg/m² in IV infusion over 30-40 minutes at D1, D8, D15 followed by 1 week of rest, every 28 days. A premedication to prevent hypersensitivity reactions (e.g., dexamethasone, diphenhydramine, H2 blockers) was applied according to the Summary of Products Characteristics. Initial antiemetic prophylaxis was also recommended. Secondary prophylaxis of neutropenia (G-CSF) for weekly chemotherapy was not planned in EORTC recommendations. Center’s practices was applied. Of note, the coordinator of the study was used to prescribe successfully pegylated G-CSF (pegfilgastrim=Neulasta®) on D1 and D15 of each cycle according to other published experience for weekly chemotherapy schedules. At each infusion day, paclitaxel was administered before gemcitabine.

    Reporting group title
    Arm B
    Reporting group description
    		 The patients randomized in this arm received Gemcitabine 1000 mg/m² in IV infusion over 30-40 minutes at D1, D8, D15 followed by 1 week of rest, every 28 days.

    Primary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    The primary endpoint of the study is overall survival defined as the time from the date of randomization to the date of death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive.
    End point type
    Primary
    End point timeframe
    From the date of randomization to the date of death due to any cause.
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    140
    71
    Units: Months
        median (confidence interval 95%)
    6.4 (5.2 to 7.4)
    5.9 (4.6 to 6.9)
    Statistical analysis title
    		 OS analysis
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4095
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.2

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    Progression Free Survival (PFS) is defined as the time from randomization until the date of event defined as the first documented progression, according to investigator assessment of RECIST version 1.1, or death (by any cause in the absence of progression). Patients who have not progressed or died at the time of analysis are censored at the time of the latest date of assessment from their last evaluable RECIST assessment.
    End point type
    Secondary
    End point timeframe
    From randomization until the date of event defined as the first documented progression, according to investigator assessment of RECIST version 1.1, or death (by any cause in the absence of progression)
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    140
    71
    Units: Months
        median (confidence interval 95%)
    3.1 (2.2 to 4.3)
    2.0 (1.9 to 2.3)
    Statistical analysis title
    		 PSF analysis
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0067
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 0.89

    Secondary: Objective response rate (ORR)

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    End point title
    		 Objective response rate (ORR)
    End point description
    Objective response rate (ORR) is defined as the proportion of patients with a complete or a partial response (CR or PR) as best overall response during the study.
    End point type
    Secondary
    End point timeframe
    Objective Response rate according to RECIST v1.1 criteria
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    137 [1]
    71
    Units: percent
        number (confidence interval 95%)
    17.5 (11.6 to 24.9)
    4.2 (0.9 to 11.9)
    Notes
    [1] - 3 missing data for objective response.
    Statistical analysis title
    		 ORR analysis
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Chi-2
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Start at the date of the signature of the informed consent form to 30 days after the last adminitsration of the investigational product.
    Adverse event reporting additional description
    For this study, the safety population consist of 208 patients: 138 in arm A (GEMPAX) and 70 in arm B (gemcitabine). For non serious adverse events only treatment-related adverse events (TRAEs) were available. The number of occurrence are not available and will be always noted "1"
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -

    Serious adverse events
    		 Arm A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    71 / 138 (51.45%)
    26 / 70 (37.14%)
         number of deaths (all causes)
    122
    65
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Peritoneal carcinomatosis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tumor progression
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Fever
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hyperthermia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mucositis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary edema
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COPD exacerbation
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cryptogenic organizing pneumonia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 138 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Interstitial lung disease
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusion
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Biliary stent occlusion
         subjects affected / exposed
    2 / 138 (1.45%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fractured wrist
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral fracture
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Angina syndrome
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Coma
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischemic stroke
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neurological impairment
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychomotor regression syndrome
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         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
    Anemia
         subjects affected / exposed
    6 / 138 (4.35%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    4 / 6
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Anemia post chemotherapy
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplasia bone marrow
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bicytopenia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (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
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombopenia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 138 (3.62%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Acute pancreatitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bleeding oesophageal varices
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal haemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric hemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric ulcer hemorrhage
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal bleeding
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrojejunal ulcer, acute with perforation
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemorrhage of digestive tract
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    6 / 138 (4.35%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subocclusive syndrome
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 138 (2.90%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute acalculous cholecystitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct obstruction
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiolitis
         subjects affected / exposed
    0 / 138 (0.00%)
    5 / 70 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    2 / 138 (1.45%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Function liver abnormal
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Icterus
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal insufficiency
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Biliary sepsis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Catheter infection
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    SARS-CoV-2 infection
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 138 (1.45%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary infection
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcemia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (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
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    138 / 138 (100.00%)
    69 / 70 (98.57%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    70 / 138 (50.72%)
    29 / 70 (41.43%)
         occurrences all number
    1
    1
    Fatigue
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    General physical health deterioration
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hyperthermia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypothermia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    4 / 138 (2.90%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    11 / 138 (7.97%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Oedema
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    0
    0
    Oedema peripheral
         subjects affected / exposed
    26 / 138 (18.84%)
    4 / 70 (5.71%)
         occurrences all number
    1
    1
    Pain
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    11 / 138 (7.97%)
    3 / 70 (4.29%)
         occurrences all number
    1
    1
    Xerosis
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypersensitivity
         subjects affected / exposed
    2 / 138 (1.45%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    3 / 138 (2.17%)
    2 / 70 (2.86%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    8 / 138 (5.80%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Hiccups
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Interstitial lung disease
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Laryngeal pain
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Organising pneumonia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 138 (4.35%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 138 (4.35%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    4 / 138 (2.90%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    8 / 138 (5.80%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Lymphocyte count increased
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Platelet count decreased
         subjects affected / exposed
    12 / 138 (8.70%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Serum ferritin decreased
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    2 / 138 (1.45%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    3 / 138 (2.17%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Aplasia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Cardiac failure
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dysaesthesia
         subjects affected / exposed
    2 / 138 (1.45%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Dysgeusia
         subjects affected / exposed
    10 / 138 (7.25%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    4 / 138 (2.90%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    60 / 138 (43.48%)
    3 / 70 (4.29%)
         occurrences all number
    1
    1
    Neurotoxicity
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Paraesthesia
         subjects affected / exposed
    16 / 138 (11.59%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Presyncope
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    78 / 138 (56.52%)
    18 / 70 (25.71%)
         occurrences all number
    1
    1
    Bicytopenia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Eosinophilia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Febrile neutropenia
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Leucocytosis
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Leucopenia
         subjects affected / exposed
    5 / 138 (3.62%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Lymphopenia
         subjects affected / exposed
    6 / 138 (4.35%)
    3 / 70 (4.29%)
         occurrences all number
    1
    1
    Neutropenia
         subjects affected / exposed
    39 / 138 (28.26%)
    13 / 70 (18.57%)
         occurrences all number
    1
    1
    Thrombocytopenia
         subjects affected / exposed
    66 / 138 (47.83%)
    18 / 70 (25.71%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Eye disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 138 (0.72%)
    2 / 70 (2.86%)
         occurrences all number
    1
    1
    Abdominal pain
         subjects affected / exposed
    8 / 138 (5.80%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Ascites
         subjects affected / exposed
    1 / 138 (0.72%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    Constipation
         subjects affected / exposed
    9 / 138 (6.52%)
    8 / 70 (11.43%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    38 / 138 (27.54%)
    9 / 70 (12.86%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    3 / 138 (2.17%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal toxicity
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    53 / 138 (38.41%)
    25 / 70 (35.71%)
         occurrences all number
    1
    1
    Odynophagia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia oral
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    10 / 138 (7.25%)
    2 / 70 (2.86%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    22 / 138 (15.94%)
    10 / 70 (14.29%)
         occurrences all number
    1
    1
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    3 / 138 (2.17%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Hepatic cytolysis
         subjects affected / exposed
    8 / 138 (5.80%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    45 / 138 (32.61%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Cutaneous symptom
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    5 / 138 (3.62%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Nail disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Night sweats
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Onycholysis
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    4 / 138 (2.90%)
    4 / 70 (5.71%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    6 / 138 (4.35%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Rash pruritic
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Skin disorder
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Skin fissures
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Skin toxicity
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Stasis dermatitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 138 (5.07%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Muscle spasms
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    7 / 138 (5.07%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Myositis
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Erysipelas
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Genital infection fungal
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    3 / 138 (2.17%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Localised infection
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Oral fungal infection
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Sepsis
         subjects affected / exposed
    0 / 138 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Appetite decreased
         subjects affected / exposed
    18 / 138 (13.04%)
    7 / 70 (10.00%)
         occurrences all number
    1
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    2 / 138 (1.45%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    3 / 138 (2.17%)
    1 / 70 (1.43%)
         occurrences all number
    1
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 138 (0.72%)
    0 / 70 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Dec 2019
    - Modification of inclusion criterion #4 to introduce a time margin in the definition of progression on FOLFIRINOX - Rewording of non-inclusion criterion #6 concerning previous treatment to include a limitation to prior treatment with gemcitabine - Changes to the Glasgow score calculation method and the frequency with which this score must be determined - Changes to the neurological examination schedule - Changes to the hematological and biological examination schedule - Update of the list of investigators - Update of the patient information notice and creation of an addendum to the patient information notice
    29 Jun 2020
    Letter to ANSM for informing of the suspension of study inclusiosn during the COVID 19 pandemic
    23 Jul 2020
    - Details for performing the Conjugated Bilirubin Assay (direct) - Modification of the schedule for clinical examinations, vital sign and performance index measurements performance index (ECOG-PS) - Correction of an error in the patient information notice, update of the schedule of visits, the section on data processing and creation of an addendum to the information notice - Update of the list of investigators
    17 Dec 2021
    - Addition of collection of archived tumour material for patients randomised in the trial - Update of the list of investigators - Creation of an addendum to the patient information notice

    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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