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    Clinical Trial Results:
    A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

    Summary
    EudraCT number
    		 2014-003510-82
    Trial protocol
    		 FR  
    Global end of trial date
    08 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    UC-0110/1405
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02539537
    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 01 71 93 67 04, n.a-rahmoune@unicancer.fr
    Scientific contact
    Nourredine AIT-RAHMOUNE, UNICANCER, 33 01 71 93 67 04, n.a-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
    06 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to compare the progression-free survival (PFS) of the disease in both arms of treatment.
    Protection of trial subjects
    This study was conducted in accordance with the French national regulatory requirements and 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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Mar 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 171
    Worldwide total number of subjects
    171
    EEA total number of subjects
    171
    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)
    62
    From 65 to 84 years
    109
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From 23-Mar-2015 to 12-Jan-2022, 171 patients were randomized in 1:1 ratio in the NEOPAN study across 30 sites. Thus, 86 patients were allocated in the gemcitabine Arm A and 85 patients in the FOLFIRINOX Arm B.

    Pre-assignment
    Screening details
    		 The main criteria for inclusion : patients with locally adenocarcinoma of the pancreas, confirmed through a histologic or cytological examination and inoperable nature confirmed after a multi-discipline discussion involving a surgeon and radiologist.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: Gemcitabine
    Arm description
    		 Gemcitabine was administered at a dose of 1,000 mg/m2, by intravenous infusion (strictly) over 30 minutes. It could be administered on an outpatient basis (day hospital), but not at the patient's home. Gemcitabine administration had to be repeated once a week for 3 consecutive weeks (D1, D8 and D15 of a cycle), followed by a week without injection (1 cycle = 4 weeks) except during the first cycle, which includes an additional infusion of Gemcitabine on D22. Doses were adjusted before each administration of chemotherapy, depending on the patient's weight and individual tolerance to gemcitabine. The dose of gemcitabine was recalculated if the weight change was ≥ 10%. Gemcitabine treatment was continued for 24 weeks (19 injections and 6 cycles).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received 1,000 mg/m² on a 30-minute drip for 3 weeks (D1, D8, D15) on each cycle, followed by a week of rest, except for the first cycle which included an additional administration at D22 (19 administrations, 6 cycles, 24 weeks).

    Arm title
    		 Arm B: FOLFIRINOX
    Arm description
    		 Treatment started with oxaliplatin 85 mg/m2 as a 2-hour IV infusion, followed by simultaneous administration (via Y-line) of folinic acid 400 mg/m2 (racemic) (or 200 mg/m2 if L-folinic acid) as a 2-hour IV infusion, and then irinotecan 180 mg/m2 as a 90-min IV infusion. The irinotecan infusion was started 30 minutes after the start of the folinic acid infusion. 5-FU (2400 mg/m2/h) was administered as a continuous IV infusion over 46 hours after the end of the folinic acid infusion, i.e. 1200 mg/m2/day for the 2 days. The next cycle started on D15. Treatment could be given on an outpatient basis (day hospital), but not at the patient's home. Treatment was continued for 24 weeks (12 cycles).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received 400 mg/m² on 2-hour IV drip.

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received 180 mg/m² on D1 for 90 minutes, begin 30 minutes after starting the folinic acid drip.

    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
    Patients received 85 mg/m² on D1 for 2 hours.

    Investigational medicinal product name
    5-Fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received 2,400 mg/m² IV in IV drip continuous for 48 hours (1,200 mg/m²/day).

    Number of subjects in period 1
    		Arm A: Gemcitabine Arm B: FOLFIRINOX
    Started
    86
    85
    Completed
    51
    55
    Not completed
    35
    30
         Physician decision
    1
    -
         Patient decision
    1
    1
         Disease progression
    19
    21
         Death
    6
    1
         Adverse event
    7
    6
         Not treated
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: Gemcitabine
    Reporting group description
    		 Gemcitabine was administered at a dose of 1,000 mg/m2, by intravenous infusion (strictly) over 30 minutes. It could be administered on an outpatient basis (day hospital), but not at the patient's home. Gemcitabine administration had to be repeated once a week for 3 consecutive weeks (D1, D8 and D15 of a cycle), followed by a week without injection (1 cycle = 4 weeks) except during the first cycle, which includes an additional infusion of Gemcitabine on D22. Doses were adjusted before each administration of chemotherapy, depending on the patient's weight and individual tolerance to gemcitabine. The dose of gemcitabine was recalculated if the weight change was ≥ 10%. Gemcitabine treatment was continued for 24 weeks (19 injections and 6 cycles).

    Reporting group title
    Arm B: FOLFIRINOX
    Reporting group description
    		 Treatment started with oxaliplatin 85 mg/m2 as a 2-hour IV infusion, followed by simultaneous administration (via Y-line) of folinic acid 400 mg/m2 (racemic) (or 200 mg/m2 if L-folinic acid) as a 2-hour IV infusion, and then irinotecan 180 mg/m2 as a 90-min IV infusion. The irinotecan infusion was started 30 minutes after the start of the folinic acid infusion. 5-FU (2400 mg/m2/h) was administered as a continuous IV infusion over 46 hours after the end of the folinic acid infusion, i.e. 1200 mg/m2/day for the 2 days. The next cycle started on D15. Treatment could be given on an outpatient basis (day hospital), but not at the patient's home. Treatment was continued for 24 weeks (12 cycles).

    Reporting group values
    		 Arm A: Gemcitabine Arm B: FOLFIRINOX Total
    Number of subjects
    		 86 85 171
    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)
    		 32 30 62
        From 65-84 years
    		 54 55 109
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 68 (43 to 81) 68 (42 to 84) -
    Gender categorical
    Units: Subjects
        Female
    		 46 40 86
        Male
    		 40 45 85
    ECOG performance status
    Units: Subjects
        ECOG 0
    		 38 37 75
        ECOG 1
    		 47 48 95
        Missing
    		 1 0 1
    Head of pancreas tumor
    Units: Subjects
        No
    		 37 41 78
        Yes
    		 49 44 93

    End points

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    End points reporting groups
    Reporting group title
    Arm A: Gemcitabine
    Reporting group description
    		 Gemcitabine was administered at a dose of 1,000 mg/m2, by intravenous infusion (strictly) over 30 minutes. It could be administered on an outpatient basis (day hospital), but not at the patient's home. Gemcitabine administration had to be repeated once a week for 3 consecutive weeks (D1, D8 and D15 of a cycle), followed by a week without injection (1 cycle = 4 weeks) except during the first cycle, which includes an additional infusion of Gemcitabine on D22. Doses were adjusted before each administration of chemotherapy, depending on the patient's weight and individual tolerance to gemcitabine. The dose of gemcitabine was recalculated if the weight change was ≥ 10%. Gemcitabine treatment was continued for 24 weeks (19 injections and 6 cycles).

    Reporting group title
    Arm B: FOLFIRINOX
    Reporting group description
    		 Treatment started with oxaliplatin 85 mg/m2 as a 2-hour IV infusion, followed by simultaneous administration (via Y-line) of folinic acid 400 mg/m2 (racemic) (or 200 mg/m2 if L-folinic acid) as a 2-hour IV infusion, and then irinotecan 180 mg/m2 as a 90-min IV infusion. The irinotecan infusion was started 30 minutes after the start of the folinic acid infusion. 5-FU (2400 mg/m2/h) was administered as a continuous IV infusion over 46 hours after the end of the folinic acid infusion, i.e. 1200 mg/m2/day for the 2 days. The next cycle started on D15. Treatment could be given on an outpatient basis (day hospital), but not at the patient's home. Treatment was continued for 24 weeks (12 cycles).

    Primary: The progression-free survival (PFS)

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    End point title
    		 The progression-free survival (PFS)
    End point description
    PFS was defined as the time elapsed between the randomization date and the tumor progression date or death (from any cause) or the date of the last study visit (for alive patients that do not present tumor progression). The progression was defined as follow: - An increase of at least 20% in the sum of target lesion diameters compared to the smallest sum of target lesions during the trial, including the reference assessment (baseline) with an absolute increase in the sum of at least 5 mm (RECIST 1.1). - Appearance of new lesions (RECIST 1.1).
    End point type
    Primary
    End point timeframe
    From randomization until disease progression or date of death, assessed up until to 128 weeks.
    End point values
    		 Arm A: Gemcitabine Arm B: FOLFIRINOX
    Number of subjects analysed
    85
    83
    Units: Months
        median (confidence interval 95%)
    7.7 (6.2 to 9.2)
    9.7 (7.0 to 11.7)
    Statistical analysis title
    		 PFS analysis
    Comparison groups
    Arm A: Gemcitabine v Arm B: FOLFIRINOX
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0243
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 0.95

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    The OS was defined as the time elapsed between the randomization date and date of death (or the last monitoring visit for alive patients).
    End point type
    Secondary
    End point timeframe
    Until death, assessed up 128 weeks after randomization
    End point values
    		 Arm A: Gemcitabine Arm B: FOLFIRINOX
    Number of subjects analysed
    86
    84
    Units: Months
        median (confidence interval 95%)
    15.4 (11.7 to 18.6)
    15.7 (11.9 to 20.4)
    No statistical analyses for this end point

    Secondary: Modality of PFS events

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    End point title
    		 Modality of PFS events
    End point description
    The failure modality were events such as distant progression (metastases) or loco-regional progression or death without progression.
    End point type
    Secondary
    End point timeframe
    Until Disease Progression, assessed uo until 128 weeks after randomization.
    End point values
    		 Arm A: Gemcitabine Arm B: FOLFIRINOX
    Number of subjects analysed
    85 [1]
    83 [2]
    Units: percent
    number (not applicable)
        Local relapse
    41.18
    48.19
        Metastatic relapse
    44.71
    43.37
        Death without progression
    14.12
    8.43
    Notes
    [1] - 85 out of the 86 randomized patients experienced a progression event in arm A.
    [2] - 83 out of the 84 randomized patients experienced a progression event in arm B.
    No statistical analyses for this end point

    Secondary: Curative surgery

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    End point title
    		 Curative surgery
    End point description
    Percentage of patients who were undergo excision of their pancreatic tumor, with R0 resection confirmed by an anatomo-pathologist.
    End point type
    Secondary
    End point timeframe
    Until surgery, if applicable, up until 128 weeks after randomization
    End point values
    		 Arm A: Gemcitabine Arm B: FOLFIRINOX
    Number of subjects analysed
    86
    85
    Units: percent
        number (confidence interval 95%)
    4.7 (1.3 to 11.0)
    5.9 (1.9 to 13.0)
    No statistical analyses for this end point

    Secondary: Tumor response

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    End point title
    		 Tumor response
    End point description
    The objective response rate (ORR) was defined as the percentage of patients with a complete response (CR) or partial response (PR) as assessed by the investigator using RECIST 1.1
    End point type
    Secondary
    End point timeframe
    Until disease progression or date of death, assessed up until 128 weeks after randomization.
    End point values
    		 Arm A: Gemcitabine Arm B: FOLFIRINOX
    Number of subjects analysed
    86
    85
    Units: percent
    number (confidence interval 95%)
        Objective response
    15.1 (8.3 to 24.5)
    42.4 (31.7 to 53.6)
        Disease control
    88.4 (79.7 to 94.3)
    82.4 (72.6 to 89.8)
        Complete Response
    2.3 (0.3 to 8.1)
    9.4 (4.2 to 17.7)
        Partial Response
    12.8 (6.6 to 21.7)
    32.9 (23.1 to 44)
        Stable Disease
    73.3 (62.6 to 82.2)
    40 (29.5 to 51.2)
        Progressive Disease
    11.6 (5.7 to 20.3)
    17.6 (10.2 to 27.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Toxicity was evaluated during treatment, at the end of study visit (3-5 weeks after the last chemotherapy cycle) and at follow-up visits (every 8 weeks after chemotherapy for 2 years then every 12 weeks for the following 3 years.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Arm A: Gemcitabine
    Reporting group description
    		 Gemcitabine was administered at a dose of 1,000 mg/m2, by intravenous infusion (strictly) over 30 minutes. It could be administered on an outpatient basis (day hospital), but not at the patient's home. Gemcitabine administration had to be repeated once a week for 3 consecutive weeks (D1, D8 and D15 of a cycle), followed by a week without injection (1 cycle = 4 weeks) except during the first cycle, which includes an additional infusion of Gemcitabine on D22. Doses were adjusted before each administration of chemotherapy, depending on the patient's weight and individual tolerance to gemcitabine. The dose of gemcitabine was recalculated if the weight change was ≥ 10%. Gemcitabine treatment was continued for 24 weeks (19 injections and 6 cycles).

    Reporting group title
    Arm B: FOLFIRINOX
    Reporting group description
    		 Treatment started with oxaliplatin 85 mg/m2 as a 2-hour IV infusion, followed by simultaneous administration (via Y-line) of folinic acid 400 mg/m2 (racemic) (or 200 mg/m2 if L-folinic acid) as a 2-hour IV infusion, and then irinotecan 180 mg/m2 as a 90-min IV infusion. The irinotecan infusion was started 30 minutes after the start of the folinic acid infusion. 5-FU (2400 mg/m2/h) was administered as a continuous IV infusion over 46 hours after the end of the folinic acid infusion, i.e. 1200 mg/m2/day for the 2 days. The next cycle started on D15. Treatment could be given on an outpatient basis (day hospital), but not at the patient's home. Treatment was continued for 24 weeks (12 cycles).

    Serious adverse events
    		 Arm A: Gemcitabine Arm B: FOLFIRINOX
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 85 (35.29%)
    35 / 84 (41.67%)
         number of deaths (all causes)
    81
    79
         number of deaths resulting from adverse events
    1
    1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thrombosis multiple
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Extravasation of drug
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile reaction
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    4 / 85 (4.71%)
    3 / 84 (3.57%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyperthermia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 85 (0.00%)
    2 / 84 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Biliary stent occlusion
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood electrolytes decreased
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endoscopic retrograde cholangiopancreatography
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Loss of consciousness
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neurological disorder NOS
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischemic attack
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         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
    1 / 85 (1.18%)
    0 / 84 (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
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile aplasia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syndrome hemolytic uremic
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Thrombotic microangiopathy
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 85 (2.35%)
    2 / 84 (2.38%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowel obstruction
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhea
         subjects affected / exposed
    1 / 85 (1.18%)
    6 / 84 (7.14%)
         occurrences causally related to treatment / all
    1 / 1
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal obstruction
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fecal impaction (causing obstruction)
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric hemorrhage
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemorrhage of digestive tract
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemorrhoidal bleeding
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melena
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction colon
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain abdominal
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 85 (2.35%)
    4 / 84 (4.76%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute cholecystitis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    3 / 85 (3.53%)
    3 / 84 (3.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dilatation biliary tract
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrenous cholecystitis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cytolysis
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive jaundice
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute retention of urine
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal insufficiency
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Infections and infestations
    Acute pyelonephritis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial translocation
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Obstructive pyelonephritis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARS-CoV-2 infection
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (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
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food intolerance
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyperglycemia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalemia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 85 (0.00%)
    2 / 84 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Arm A: Gemcitabine Arm B: FOLFIRINOX
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 85 (100.00%)
    82 / 84 (97.62%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Hypertensive crisis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Embolism
         subjects affected / exposed
    5 / 85 (5.88%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Hypertension
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Hematoma
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Venous thrombosis
         subjects affected / exposed
    3 / 85 (3.53%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Deep vein thrombosis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Cataract surgery
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Pacemaker implantation
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 85 (5.88%)
    7 / 84 (8.33%)
         occurrences all number
    1
    1
    Pain
         subjects affected / exposed
    3 / 85 (3.53%)
    2 / 84 (2.38%)
         occurrences all number
    1
    1
    General physical health deterioration
         subjects affected / exposed
    5 / 85 (5.88%)
    3 / 84 (3.57%)
         occurrences all number
    1
    1
    Extravasation at perfusion site
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    72 / 85 (84.71%)
    66 / 84 (78.57%)
         occurrences all number
    1
    1
    Chills
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Hyperthermia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Inflammation
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Catheter site inflammation
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    6 / 85 (7.06%)
    15 / 84 (17.86%)
         occurrences all number
    1
    1
    Malaise
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Oedema
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Face oedema
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Peripheral oedema
         subjects affected / exposed
    13 / 85 (15.29%)
    4 / 84 (4.76%)
         occurrences all number
    1
    1
    influenza-like syndrome
         subjects affected / exposed
    6 / 85 (7.06%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Ulcer
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Xerosis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Breast cyst
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Prostatitis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    4 / 85 (4.71%)
    2 / 84 (2.38%)
         occurrences all number
    1
    1
    Dyspnoea exertional
         subjects affected / exposed
    3 / 85 (3.53%)
    2 / 84 (2.38%)
         occurrences all number
    1
    1
    Pulmonary embolism
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Hiccups
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Laryngospasm
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Acute pulmonary edema
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 85 (0.00%)
    3 / 84 (3.57%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    2 / 85 (2.35%)
    3 / 84 (3.57%)
         occurrences all number
    1
    1
    Productive cough
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 85 (1.18%)
    4 / 84 (4.76%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 85 (2.35%)
    3 / 84 (3.57%)
         occurrences all number
    1
    1
    Depression
         subjects affected / exposed
    5 / 85 (5.88%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Mood altered
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    3 / 85 (3.53%)
    2 / 84 (2.38%)
         occurrences all number
    1
    1
    Libido disorder
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    64 / 85 (75.29%)
    55 / 84 (65.48%)
         occurrences all number
    1
    1
    Blood albumin decreased
         subjects affected / exposed
    14 / 85 (16.47%)
    10 / 84 (11.90%)
         occurrences all number
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    58 / 85 (68.24%)
    49 / 84 (58.33%)
         occurrences all number
    1
    1
    Blood chloride normal
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Creatinine renal clearance abnormal
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine abnormal
         subjects affected / exposed
    11 / 85 (12.94%)
    7 / 84 (8.33%)
         occurrences all number
    1
    1
    Blood creatine decreased
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Blood creatinine decreased
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Serum ferritin
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Blood fibrinogen
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    58 / 85 (68.24%)
    59 / 84 (70.24%)
         occurrences all number
    1
    1
    Blood glucose
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Blood lactate dehydrogenase
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Blood magnesium
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Blood magnesium decreased
         subjects affected / exposed
    4 / 85 (4.71%)
    4 / 84 (4.76%)
         occurrences all number
    1
    1
    Monocyte count increased
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Neutrophil count
         subjects affected / exposed
    51 / 85 (60.00%)
    39 / 84 (46.43%)
         occurrences all number
    1
    1
    Lymphocyte count
         subjects affected / exposed
    46 / 85 (54.12%)
    25 / 84 (29.76%)
         occurrences all number
    1
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    43 / 85 (50.59%)
    57 / 84 (67.86%)
         occurrences all number
    1
    1
    Platelet count
         subjects affected / exposed
    56 / 85 (65.88%)
    59 / 84 (70.24%)
         occurrences all number
    1
    1
    Weight decreased
         subjects affected / exposed
    40 / 85 (47.06%)
    42 / 84 (50.00%)
         occurrences all number
    1
    1
    Blood potassium increased
         subjects affected / exposed
    8 / 85 (9.41%)
    4 / 84 (4.76%)
         occurrences all number
    1
    1
    Blood potassium decreased
         subjects affected / exposed
    3 / 85 (3.53%)
    6 / 84 (7.14%)
         occurrences all number
    1
    1
    Blood sodium decreased
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Blood urea increased
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Blood urea decreased
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    6 / 85 (7.06%)
    3 / 84 (3.57%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Device defective
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Head injury
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Device occlusion
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Perfusion related reaction
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Aplasia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Cardiac disorders
    Heart failure
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Cardiac disorder
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Ageusia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Anosmia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Aphasia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Memory disorder
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    3 / 85 (3.53%)
    2 / 84 (2.38%)
         occurrences all number
    1
    1
    Dysesthesia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    7 / 85 (8.24%)
    12 / 84 (14.29%)
         occurrences all number
    1
    1
    Taste disorder
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Hypogeusia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Peripheral neuropathy
         subjects affected / exposed
    8 / 85 (9.41%)
    70 / 84 (83.33%)
         occurrences all number
    1
    1
    Paresthesia
         subjects affected / exposed
    0 / 85 (0.00%)
    4 / 84 (4.76%)
         occurrences all number
    0
    1
    Parosmia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    consciousness lost
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Syncope
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Cholinergic syndrome
         subjects affected / exposed
    0 / 85 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Essential tremor
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    speech disorder
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Nervous system disorder
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    75 / 85 (88.24%)
    66 / 84 (78.57%)
         occurrences all number
    1
    1
    Bone marrow aplasia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Hyperleucocytosis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Leucopenia
         subjects affected / exposed
    49 / 85 (57.65%)
    27 / 84 (32.14%)
         occurrences all number
    1
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Lymphopenia
         subjects affected / exposed
    3 / 85 (3.53%)
    2 / 84 (2.38%)
         occurrences all number
    1
    1
    Thrombotic microangiopathy
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Febrile neutropenia
         subjects affected / exposed
    2 / 85 (2.35%)
    3 / 84 (3.57%)
         occurrences all number
    1
    1
    Hemolytic syndrome
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Thrombopenia
         subjects affected / exposed
    0 / 85 (0.00%)
    4 / 84 (4.76%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Positional vertigo
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Visual field defect
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Eye haemorrhage
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
         subjects affected / exposed
    1 / 85 (1.18%)
    3 / 84 (3.57%)
         occurrences all number
    1
    1
    Constipation
         subjects affected / exposed
    28 / 85 (32.94%)
    25 / 84 (29.76%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    40 / 85 (47.06%)
    67 / 84 (79.76%)
         occurrences all number
    1
    1
    Abdominal distension
         subjects affected / exposed
    2 / 85 (2.35%)
    4 / 84 (4.76%)
         occurrences all number
    1
    1
    Abdominal pain
         subjects affected / exposed
    52 / 85 (61.18%)
    60 / 84 (71.43%)
         occurrences all number
    1
    1
    Upper abdominal pain
         subjects affected / exposed
    8 / 85 (9.41%)
    7 / 84 (8.33%)
         occurrences all number
    1
    1
    Tooth pain
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    2 / 85 (2.35%)
    4 / 84 (4.76%)
         occurrences all number
    1
    1
    Dysphagia
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Anal fistula
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Fecaloma
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Inguinal hernia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal hemorrhage
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Rectal hemorrhage
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Hemorrhoids
         subjects affected / exposed
    0 / 85 (0.00%)
    3 / 84 (3.57%)
         occurrences all number
    0
    1
    Pancreatic cyst
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    46 / 85 (54.12%)
    67 / 84 (79.76%)
         occurrences all number
    1
    1
    Duodenal occlusion
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Intestinal occlusion
         subjects affected / exposed
    2 / 85 (2.35%)
    2 / 84 (2.38%)
         occurrences all number
    1
    1
    Gingival oedema
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Proctalgia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Ptyalisme
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Gingival retraction
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    1 / 85 (1.18%)
    2 / 84 (2.38%)
         occurrences all number
    1
    1
    Aphthous ulcer
         subjects affected / exposed
    1 / 85 (1.18%)
    2 / 84 (2.38%)
         occurrences all number
    1
    1
    Duodenal ulcer
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    32 / 85 (37.65%)
    44 / 84 (52.38%)
         occurrences all number
    1
    1
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    3 / 85 (3.53%)
    2 / 84 (2.38%)
         occurrences all number
    1
    1
    Cholestasis
         subjects affected / exposed
    1 / 85 (1.18%)
    4 / 84 (4.76%)
         occurrences all number
    1
    1
    Cholecystitis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Acute cholecystitis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Hepatic cytolysis
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 85 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    0
    1
    Jaundice
         subjects affected / exposed
    4 / 85 (4.71%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Liver disorder
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Alopecia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Angioedema
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Skin fissures
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    8 / 85 (9.41%)
    3 / 84 (3.57%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    0 / 85 (0.00%)
    3 / 84 (3.57%)
         occurrences all number
    0
    1
    Maculo-papular rash
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Skin reaction
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Acral syndrome
         subjects affected / exposed
    1 / 85 (1.18%)
    9 / 84 (10.71%)
         occurrences all number
    1
    1
    Skin toxicity
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Skin ulcer
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Vesical dilatation
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Dysuria
         subjects affected / exposed
    3 / 85 (3.53%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Glycosuria
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Renal failure
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Nycturia
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Nephrolithiasis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Proteinuria
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Arthropathy
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Cervical pain
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    muscle contractions
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Dorsal pain
         subjects affected / exposed
    7 / 85 (8.24%)
    11 / 84 (13.10%)
         occurrences all number
    1
    1
    Jaw pain
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Flank pain
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Bone pain
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Hypercreatinaemia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    6 / 85 (7.06%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Sacral pain
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Trismus
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Infections and infestations
    Tooth abscess
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Liver abscess
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Cholecystitis infective
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    0 / 85 (0.00%)
    3 / 84 (3.57%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Infection
         subjects affected / exposed
    5 / 85 (5.88%)
    6 / 84 (7.14%)
         occurrences all number
    1
    1
    Injection site infection
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Catheter site infection
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 85 (2.35%)
    5 / 84 (5.95%)
         occurrences all number
    1
    1
    Genital infection
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Viral infection
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Oral mycosis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Pyelonephritis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Pyelonephritis acute
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Erysipelas
         subjects affected / exposed
    3 / 85 (3.53%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Synovial cyst
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Appetite decreased
         subjects affected / exposed
    39 / 85 (45.88%)
    39 / 84 (46.43%)
         occurrences all number
    1
    1
    Diabetes
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Iron deficiency
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Malnutrition
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Dehydration
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Hyperchloraemia
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Hyperglycaemia
         subjects affected / exposed
    28 / 85 (32.94%)
    30 / 84 (35.71%)
         occurrences all number
    1
    1
    Hypernatraemia
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    3 / 85 (3.53%)
    4 / 84 (4.76%)
         occurrences all number
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    9 / 85 (10.59%)
    10 / 84 (11.90%)
         occurrences all number
    1
    1
    Hypochloraemia
         subjects affected / exposed
    4 / 85 (4.71%)
    4 / 84 (4.76%)
         occurrences all number
    1
    1
    Hypoglycaemia
         subjects affected / exposed
    2 / 85 (2.35%)
    3 / 84 (3.57%)
         occurrences all number
    1
    1
    Hypokalaemia
         subjects affected / exposed
    9 / 85 (10.59%)
    8 / 84 (9.52%)
         occurrences all number
    1
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 85 (1.18%)
    3 / 84 (3.57%)
         occurrences all number
    1
    1
    Hyponatraemia
         subjects affected / exposed
    14 / 85 (16.47%)
    9 / 84 (10.71%)
         occurrences all number
    1
    1
    Hypoproteinaemia
         subjects affected / exposed
    0 / 85 (0.00%)
    3 / 84 (3.57%)
         occurrences all number
    0
    1
    Cell death
         subjects affected / exposed
    3 / 85 (3.53%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Feb 2015
    - Modification of the investigators list
    11 Feb 2016
    - Modification of the investigators list
    27 Sep 2016
    - Modification of the investigators list - Update of the protocol - Update of the information and consent form
    20 Feb 2017
    - Modification of the investigators list
    19 Apr 2017
    - Modification of the investigators list
    12 Mar 2018
    - Modification of the investigators list
    24 Apr 2019
    - Modification of the investigators list - Preventive measure against severe toxicities in the context of fluoropyrimidine-based treatment: Modification of inclusion criteria (addition of inclusion criterion no. 12 in the protocol). - Addition of information required by the GDPR in the information and consent forms.
    25 May 2020
    - The investigators list was modified - Inclusion period were extended
    09 Dec 2021
    - The investigators list was modified
    23 Nov 2023
    The sponsor UNICANCER had decided to stop monitoring the last patients on 25-Sep-2023 (i.e. a follow-up of approximately 2 years after the inclusion of the last patient instead of the 5-year follow-up initially planned). Since the recruitment took longer than initially planned, and the results obtained with data collected up to 25-Sep-2023 were complete to assess the protocol objectives, the study was stopped before its planned end.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    04 Apr 2024
    The NEOPAN study was terminated earlier than the planned date. The sponsor UNICANCER had decided to stop monitoring the last patients on 25-Sep-2023 (i.e. a follow-up of approximately 2 years after the inclusion of the last patient instead of the 5-year follow-up initially planned). Since the recruitment took longer than initially planned, and the results obtained with data collected up to 25-Sep-2023 were complete to assess the protocol objectives, the study was stopped before its planned end.
    -

    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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