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    Clinical Trial Results:
    CAO/ARO/AIO-12: Induction chemotherapy before or after preoperative chemoradiotherapy and surgery for locally advanced rectal cancer: A randomized phase II trial of the German Rectal Cancer Study Group

    Summary
    EudraCT number
    		 2011-006310-13
    Trial protocol
    		 DE  
    Global end of trial date
    16 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Mar 2024
    First version publication date
    11 Mar 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAO/ARO/AIO-12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02363374
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Goethe University
    Sponsor organisation address
    Theodor-Stern-Kai 7, Frankfurt, Germany,
    Public contact
    Dept. of Radiation Therapy and Oncology, Studiensekretariat, Goethe University Frankfurt, 0049 06963014655,
    Scientific contact
    Dept. of Radiation Therapy and Oncology, Studiensekretariat, Goethe University Frankfurt, 0049 06963014655,
    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
    16 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the efficacy of induction chemotherapy followed by chemoradiotherapy, or the other way round, before surgery in patients with locally advanced rectal cancer. As primary endpoint, the rate of patients with pathological complete remissions (pCR) will be compared exploratively between the treatment arms and to expectations derived from historical data.
    Protection of trial subjects
    A Data Safety and Monitoring Board with at least three members will be established, consisting of experts in medical, surgical or radiotherapeutic oncology specializing in rectal cancer, and a statistical expert. The DSMB will receive regular information on safety results of the trial, namely a list of reported SAEs/SUSARs.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 311
    Worldwide total number of subjects
    311
    EEA total number of subjects
    311
    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)
    194
    From 65 to 84 years
    117
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 – 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)

    Pre-assignment
    Screening details
    		 Patients diagnosed with rectal cancer have been screened

    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
    		 Control arm A
    Arm description
    		 The therapy starts with three induction chemotherapy cycles (Folinic acid: 400 mg/m^2, 2h-civ Oxaliplatin: 100 mg/m^2, 2h-civ, 5-FU: 2400 mg/m^2, 46h-civ) followed by chemoradiotherapy (Radiotherapy: 28 x 1.8 Gy; total 50.4 Gy, 5 fractions per week, 5-FU: 250 mg/m^2 per day, civ, on day 1-14, day 22-35 of radiotherapy, Oxaliplatin: 50 mg/m2, day 1, 8, 22, and 29 of radiotherapy) Accordingly, chemoradiotherapy should be finalized on day 81, if no delays are required. Surgery should be performed about 6 weeks later, i.e. around day 123.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for intraocular irrigation
    Routes of administration
    Intravenous use
    Dosage and administration details
    Oxaliplatin: 100 mg/m^2, 2h-civ on day 1, 15 and 29 + 50 mg/m2, day 1, 8, 22, and 29 of radiotherapy, total 500 mg/m2

    Investigational medicinal product name
    Fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2400 mg/m^2, 46h-civ on day 1, 15 and 29 + 250 mg/m^2 per day, civ, on day 1-14, day 22-35 of radiotherapy, total 14200 mg/m2

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m^2, 2h-civ on day 1, 15 and 29, total 1200 mg/m2

    Arm title
    		 Experimental arm B
    Arm description
    		 The therapy starts with chemoradiotherapy (Radiotherapy: 28 x 1.8 Gy; total 50.4 Gy, 5 fractions per week, 5-FU: 250 mg/m^2 per day, civ, on day 1-14, day 22-35 of radiotherapy, Oxaliplatin: 50 mg/m2, day 1, 8, 22, and 29 of radiotherapy) followed by three chemotherapy cycles (Folinic acid: 400 mg/m^2, 2h-civ Oxaliplatin: 100 mg/m^2, 2h-civ, 5-FU: 2400 mg/m^2, 46h-civ). Surgery should be performed about 6 weeks later, i.e. around day 123.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for intraocular irrigation
    Routes of administration
    Intravenous use
    Dosage and administration details
    Oxaliplatin: 50 mg/m2, day 1, 8, 22, and 29 of radiotherapy + 100 mg/m^2, 2h-civ on day on day 57, 71 and 85, total 500 mg/m2

    Investigational medicinal product name
    Fluorouracil
    Investigational medicinal product code
    Other name
    5-FU
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    250 mg/m^2 per day, civ, on day 1-14, day 22-35 of radiotherapy+ 2400 mg/m^2, 46h-civ on day 57, 71 and 85, total 14200 mg/m2

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m^2, 2h-civ on day 1, 15 and 29, total 1200 mg/m2

    Number of subjects in period 1 [1]
    		Control arm A Experimental arm B
    Started
    156
    150
    Completed
    142
    142
    Not completed
    14
    8
         Adverse event, serious fatal
    1
    1
         refused because of cCR
    6
    4
         unknown
    1
    2
         refused because of other reason
    -
    1
         No matching reasons found
    4
    -
         Lack of efficacy
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 311 patients were randomized but 5 patients were excluded because of constent withdrawel or protocol entry violation. All further analyses were performed within the 306 patients. [https://doi.org/10.1200/JCO.19.00308]

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control arm A
    Reporting group description
    		 The therapy starts with three induction chemotherapy cycles (Folinic acid: 400 mg/m^2, 2h-civ Oxaliplatin: 100 mg/m^2, 2h-civ, 5-FU: 2400 mg/m^2, 46h-civ) followed by chemoradiotherapy (Radiotherapy: 28 x 1.8 Gy; total 50.4 Gy, 5 fractions per week, 5-FU: 250 mg/m^2 per day, civ, on day 1-14, day 22-35 of radiotherapy, Oxaliplatin: 50 mg/m2, day 1, 8, 22, and 29 of radiotherapy) Accordingly, chemoradiotherapy should be finalized on day 81, if no delays are required. Surgery should be performed about 6 weeks later, i.e. around day 123.

    Reporting group title
    Experimental arm B
    Reporting group description
    		 The therapy starts with chemoradiotherapy (Radiotherapy: 28 x 1.8 Gy; total 50.4 Gy, 5 fractions per week, 5-FU: 250 mg/m^2 per day, civ, on day 1-14, day 22-35 of radiotherapy, Oxaliplatin: 50 mg/m2, day 1, 8, 22, and 29 of radiotherapy) followed by three chemotherapy cycles (Folinic acid: 400 mg/m^2, 2h-civ Oxaliplatin: 100 mg/m^2, 2h-civ, 5-FU: 2400 mg/m^2, 46h-civ). Surgery should be performed about 6 weeks later, i.e. around day 123.

    Reporting group values
    		 Control arm A Experimental arm B Total
    Number of subjects
    		 156 150 306
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 103 91 194
        From 65-84 years
    		 53 59 112
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (19 to 79) 61 (39 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 50 50 100
        Male
    		 106 100 206
    ECOG
    Units: Subjects
        ECOG 0
    		 118 100 218
        ECOG 1
    		 32 48 80
        Missing
    		 6 2 8
    clinical tumor category
    Units: Subjects
        cT2
    		 6 4 10
        cT3
    		 132 118 250
        cT4
    		 18 27 45
        missing
    		 0 1 1
    clinical node stage
    Units: Subjects
        cN0
    		 16 14 30
        cN1-2
    		 134 135 269
        missing
    		 6 1 7
    clinical disease stage
    Units: Subjects
        Stage II
    		 16 14 30
        Stage III
    		 134 135 269
        missing
    		 6 1 7
    Distance of tumor to mesorectal fascia
    Units: Subjects
        less or equal 1mm
    		 48 33 81
        more than 1mm
    		 108 117 225
        Missing
    		 0 0 0
    Location from anal verge, cm
    Units: Subjects
        0-5
    		 64 62 126
        6-10
    		 67 73 140
        11 or higher
    		 15 11 26
        missing
    		 10 4 14
    Histology
    Units: Subjects
        Adenocarcinoma
    		 152 143 295
        Mucinous adenocarcinoma
    		 1 5 6
        Singet-ring cell adenocarcinoma
    		 1 0 1
        other
    		 2 2 4
    Tumor differentiation
    Units: Subjects
        Well
    		 6 12 18
        moderatly
    		 125 113 238
        poorly
    		 11 8 19
        missing
    		 14 17 31
    Subject analysis sets

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    306 patients, five excluded because withdrawal of consent or protocol entry violation

    Subject analysis sets values
    		 Intention to treat
    Number of subjects
    306
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    194
        From 65-84 years
    112
    Age continuous
    Units: years
        median (full range (min-max))
    61 (19 to 81)
    Gender categorical
    Units: Subjects
        Female
    100
        Male
    206
    ECOG
    Units: Subjects
        ECOG 0
    218
        ECOG 1
    80
        Missing
    8
    clinical tumor category
    Units: Subjects
        cT2
    10
        cT3
    250
        cT4
    45
        missing
    1
    clinical node stage
    Units: Subjects
        cN0
    30
        cN1-2
    269
        missing
    7
    clinical disease stage
    Units: Subjects
        Stage II
    30
        Stage III
    269
        missing
    7
    Distance of tumor to mesorectal fascia
    Units: Subjects
        less or equal 1mm
    81
        more than 1mm
    225
        Missing
    0
    Location from anal verge, cm
    Units: Subjects
        0-5
    126
        6-10
    140
        11 or higher
    26
        missing
    14
    Histology
    Units: Subjects
        Adenocarcinoma
    295
        Mucinous adenocarcinoma
    6
        Singet-ring cell adenocarcinoma
    1
        other
    4
    Tumor differentiation
    Units: Subjects
        Well
    18
        moderatly
    238
        poorly
    19
        missing
    31

    End points

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    End points reporting groups
    Reporting group title
    Control arm A
    Reporting group description
    		 The therapy starts with three induction chemotherapy cycles (Folinic acid: 400 mg/m^2, 2h-civ Oxaliplatin: 100 mg/m^2, 2h-civ, 5-FU: 2400 mg/m^2, 46h-civ) followed by chemoradiotherapy (Radiotherapy: 28 x 1.8 Gy; total 50.4 Gy, 5 fractions per week, 5-FU: 250 mg/m^2 per day, civ, on day 1-14, day 22-35 of radiotherapy, Oxaliplatin: 50 mg/m2, day 1, 8, 22, and 29 of radiotherapy) Accordingly, chemoradiotherapy should be finalized on day 81, if no delays are required. Surgery should be performed about 6 weeks later, i.e. around day 123.

    Reporting group title
    Experimental arm B
    Reporting group description
    		 The therapy starts with chemoradiotherapy (Radiotherapy: 28 x 1.8 Gy; total 50.4 Gy, 5 fractions per week, 5-FU: 250 mg/m^2 per day, civ, on day 1-14, day 22-35 of radiotherapy, Oxaliplatin: 50 mg/m2, day 1, 8, 22, and 29 of radiotherapy) followed by three chemotherapy cycles (Folinic acid: 400 mg/m^2, 2h-civ Oxaliplatin: 100 mg/m^2, 2h-civ, 5-FU: 2400 mg/m^2, 46h-civ). Surgery should be performed about 6 weeks later, i.e. around day 123.

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    306 patients, five excluded because withdrawal of consent or protocol entry violation

    Primary: Pathological complete response

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    End point title
    		 Pathological complete response [1]
    End point description
    The primary end point, pathologic complete response (pCR), was defined as ypT0N0 after surgery.
    End point type
    Primary
    End point timeframe
    Start of treatment up to surgery
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical procedure is described in detail in the original publication, https://doi.org/10.1200/JCO.19.0030. It is too complex to add the analysis methods within this system.
    End point values
    		 Control arm A Experimental arm B Intention to treat
    Number of subjects analysed
    156
    150
    306
    Units: Patients
    27
    38
    65
    No statistical analyses for this end point

    Secondary: 3-year disease-free survival

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    End point title
    		 3-year disease-free survival
    End point description
    Regarding the definition of secondary endpoints, DFS was defined as the time between randomization and either macroscopically visible gross tumor after surgery (R2 resection), no resection due to tumor progression, locoregional recurrence after R0/1 resection of the primary tumor, distant metastases, or death from any cause, whichever occurred first; a local regrowth in patients with cCR and NOM was censored if salvage surgery resulted in a R0/1 resection, as recently recommended.
    End point type
    Secondary
    End point timeframe
    Time from randomization to any event listed below.
    End point values
    		 Control arm A Experimental arm B Intention to treat
    Number of subjects analysed
    156
    150
    306
    Units: Events
    46
    43
    89
    Statistical analysis title
    		 Cox regression
    Comparison groups
    Experimental arm B v Control arm A
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.45
    Variability estimate
    Standard deviation

    Secondary: 3-year cumulative incidence of locoregional recurrence

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    End point title
    		 3-year cumulative incidence of locoregional recurrence
    End point description
    The cumulative incidence of locoregional recurrence and distant metastases was defined as the time between randomization and occurrence of any locoregional recurrence (after R0/1 resection of the primary tumor) and distant metastases, respectively, irrespective of whether this was a first event or not.
    End point type
    Secondary
    End point timeframe
    Time from randomization to event listed below.
    End point values
    		 Control arm A Experimental arm B Intention to treat
    Number of subjects analysed
    156
    150
    306
    Units: Events
    9
    7
    16
    Statistical analysis title
    		 Cox regression
    Comparison groups
    Experimental arm B v Control arm A
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 2.18

    Secondary: 3-year distant metastasis

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    End point title
    		 3-year distant metastasis
    End point description
    The cumulative incidence of locoregional recurrence and distant metastases was defined as the time between randomization and occurrence of any locoregional recurrence (after R0/1 resection of the primary tumor) and distant metastases, respectively, irrespective of whether this was a first event or not.
    End point type
    Secondary
    End point timeframe
    Time from randomization to event listed below
    End point values
    		 Control arm A Experimental arm B Intention to treat
    Number of subjects analysed
    156
    150
    306
    Units: Events
    31
    25
    56
    Statistical analysis title
    		 Cox regression
    Comparison groups
    Experimental arm B v Control arm A
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.43

    Secondary: 3-year Overall survival

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    End point title
    		 3-year Overall survival
    End point description
    Overall survival (OS) was defined as time from randomization to death from any cause.
    End point type
    Secondary
    End point timeframe
    Time from randomization to death
    End point values
    		 Control arm A Experimental arm B Intention to treat
    Number of subjects analysed
    156
    150
    306
    Units: Events
    14
    15
    29
    Statistical analysis title
    		 Cox regression
    Comparison groups
    Experimental arm B v Control arm A
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 2.27

    Secondary: Acute Adverse Effects during chemoradiotherapy

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    End point title
    		 Acute Adverse Effects during chemoradiotherapy
    End point description
    End point type
    Secondary
    End point timeframe
    During chemoradiotherapy
    End point values
    		 Control arm A Experimental arm B Intention to treat
    Number of subjects analysed
    151 [2]
    149 [3]
    300 [4]
    Units: Events
        Grade 1-2
    94
    107
    201
        Grade 3
    51
    36
    87
        Grade 4
    4
    4
    8
        Grade 5
    1
    1
    2
    Notes
    [2] - patients started CRT
    [3] - patients started CRT
    [4] - patients started CRT
    No statistical analyses for this end point

    Secondary: Acute Adverse Effects during chemotherapy

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    End point title
    		 Acute Adverse Effects during chemotherapy
    End point description
    End point type
    Secondary
    End point timeframe
    during chemotherapy
    End point values
    		 Control arm A Experimental arm B Intention to treat
    Number of subjects analysed
    156
    140 [5]
    296 [6]
    Units: Events
        Grade 1-2
    117
    112
    229
        Grade 3
    33
    25
    58
        Grade 4
    1
    5
    6
        Grade 5
    0
    0
    0
    Notes
    [5] - patients who started chemotherapy
    [6] - patients who start chemotherapy
    No statistical analyses for this end point

    Secondary: Chronic toxicity after 36 months

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    End point title
    		 Chronic toxicity after 36 months
    End point description
    End point type
    Secondary
    End point timeframe
    Chronic toxicity 36 months after completion of treatment
    End point values
    		 Control arm A Experimental arm B Intention to treat
    Number of subjects analysed
    85 [7]
    66 [8]
    151
    Units: Events
        Grade 1-2
    43
    52
    95
        Grade 3-4
    10
    8
    18
    Notes
    [7] - available patients
    [8] - available patients
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any such occurrence or worsening of a pre-existing medical condition from the time that a subject has received the first dose of study treatment until the End of Treatment Visit or 30 days after the last dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    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
    69 / 156 (44.23%)
    45 / 150 (30.00%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Thromboembololic event
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 156 (1.92%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aneurysm
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 156 (1.28%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visceral arterial ischemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         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
    General physical health deterioration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 156 (2.56%)
    3 / 150 (2.00%)
         occurrences causally related to treatment / all
    6 / 6
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fever
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 156 (1.28%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extravasation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergic reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 156 (1.28%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Epididymitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Mania
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Neutropenia
    Additional description: Panzytopenia
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    creatinine increased
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         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
    Small intestinal perforation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    car incident
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal anastomotic leak
    Additional description: Post-OP
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 156 (6.41%)
    9 / 150 (6.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 156 (3.85%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal stoma leak
    Additional description: Post-OP
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative hemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 156 (1.28%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Venous injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Nervous system disorders
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stroke
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paresis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anemia
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 156 (1.28%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 156 (1.28%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 156 (1.28%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 156 (5.77%)
    4 / 150 (2.67%)
         occurrences causally related to treatment / all
    9 / 9
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
    Additional description: Post-OP
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 156 (1.28%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucositis management
    Additional description: Mucositis oral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 156 (1.28%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal hemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 156 (1.28%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal stenosis
    Additional description: Post-OP
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
    Additional description: Post-OP
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stomach pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
    Additional description: Post-OP
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    esophagitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ileus perforation
    Additional description: Post-OP
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Keratosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary tract obstruction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
    Additional description: Post-OP
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess soft tissue
    Additional description: Post-OP
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess intestinal
    Additional description: Post-OP
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    3 / 150 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    2 / 150 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 150 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    156 / 156 (100.00%)
    149 / 150 (99.33%)
    Investigations
    Leukocytes decreased
         subjects affected / exposed
    80 / 156 (51.28%)
    94 / 150 (62.67%)
         occurrences all number
    99
    132
    Neutrophil count decreased
         subjects affected / exposed
    37 / 156 (23.72%)
    40 / 150 (26.67%)
         occurrences all number
    44
    53
    Platelet count decreased
         subjects affected / exposed
    75 / 156 (48.08%)
    58 / 150 (38.67%)
         occurrences all number
    85
    76
    Dysgeusia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 156 (7.05%)
    4 / 150 (2.67%)
         occurrences all number
    11
    4
    Injury, poisoning and procedural complications
    Dermatitis radiation
         subjects affected / exposed
    63 / 156 (40.38%)
    57 / 150 (38.00%)
         occurrences all number
    71
    62
    Anastomotic leak
    Additional description: not further specified
         subjects affected / exposed [1]
    16 / 142 (11.27%)
    16 / 142 (11.27%)
         occurrences all number
    16
    16
    Urinary retention postoperative
         subjects affected / exposed [2]
    21 / 142 (14.79%)
    14 / 142 (9.86%)
         occurrences all number
    21
    14
    Erectile dysfunction
         subjects affected / exposed [3]
    6 / 96 (6.25%)
    5 / 95 (5.26%)
         occurrences all number
    6
    5
    Ileus
         subjects affected / exposed [4]
    8 / 142 (5.63%)
    12 / 142 (8.45%)
         occurrences all number
    8
    12
    postoperative hemorrhage
    Additional description: not further specified
         subjects affected / exposed [5]
    4 / 142 (2.82%)
    5 / 142 (3.52%)
         occurrences all number
    4
    5
    Wound complication sacral
         subjects affected / exposed [6]
    15 / 142 (10.56%)
    16 / 142 (11.27%)
         occurrences all number
    15
    16
    Wound complication abdominal
         subjects affected / exposed [7]
    16 / 142 (11.27%)
    8 / 142 (5.63%)
         occurrences all number
    16
    8
    Postoperative pain
    alternative assessment type: Non-systematic
         subjects affected / exposed [8]
    9 / 142 (6.34%)
    9 / 142 (6.34%)
         occurrences all number
    9
    9
    Polyneuropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed [9]
    7 / 142 (4.93%)
    7 / 142 (4.93%)
         occurrences all number
    7
    7
    Nervous system disorders
    Paresthesia
         subjects affected / exposed
    68 / 156 (43.59%)
    67 / 150 (44.67%)
         occurrences all number
    82
    80
    Oxaliplatin-induced paresthesia
    Additional description: Wassermann Score
         subjects affected / exposed
    113 / 156 (72.44%)
    103 / 150 (68.67%)
         occurrences all number
    126
    132
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 156 (5.13%)
    11 / 150 (7.33%)
         occurrences all number
    8
    11
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    102 / 156 (65.38%)
    99 / 150 (66.00%)
         occurrences all number
    136
    148
    Fever
         subjects affected / exposed
    19 / 156 (12.18%)
    11 / 150 (7.33%)
         occurrences all number
    24
    11
    Pain
    Additional description: not further specified
         subjects affected / exposed
    89 / 156 (57.05%)
    75 / 150 (50.00%)
         occurrences all number
    113
    93
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    105 / 156 (67.31%)
    98 / 150 (65.33%)
         occurrences all number
    137
    135
    Immune system disorders
    Allergic reaction to excipient
         subjects affected / exposed
    10 / 156 (6.41%)
    10 / 150 (6.67%)
         occurrences all number
    11
    13
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    129 / 156 (82.69%)
    101 / 150 (67.33%)
         occurrences all number
    163
    120
    Vomiting
         subjects affected / exposed
    34 / 156 (21.79%)
    28 / 150 (18.67%)
         occurrences all number
    40
    31
    Mucositis oral
         subjects affected / exposed
    51 / 156 (32.69%)
    33 / 150 (22.00%)
         occurrences all number
    64
    38
    Constipation
         subjects affected / exposed
    44 / 156 (28.21%)
    37 / 150 (24.67%)
         occurrences all number
    57
    43
    Procitis
         subjects affected / exposed
    66 / 156 (42.31%)
    65 / 150 (43.33%)
         occurrences all number
    73
    78
    Nausea
         subjects affected / exposed
    98 / 156 (62.82%)
    86 / 150 (57.33%)
         occurrences all number
    137
    113
    Anorexia
    Additional description: Loss of appetite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 156 (5.77%)
    4 / 150 (2.67%)
         occurrences all number
    9
    4
    Rectal haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 156 (7.05%)
    6 / 150 (4.00%)
         occurrences all number
    11
    6
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    24 / 156 (15.38%)
    17 / 150 (11.33%)
         occurrences all number
    29
    23
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 156 (3.85%)
    1 / 150 (0.67%)
         occurrences all number
    6
    1
    Renal and urinary disorders
    Cystitis noninfective
         subjects affected / exposed
    33 / 156 (21.15%)
    33 / 150 (22.00%)
         occurrences all number
    38
    42
    Urinary urgency
         subjects affected / exposed
    42 / 156 (26.92%)
    36 / 150 (24.00%)
         occurrences all number
    46
    44
    Acute kidney injury
         subjects affected / exposed
    31 / 156 (19.87%)
    16 / 150 (10.67%)
         occurrences all number
    34
    18
    Infections and infestations
    Infection
    Additional description: not specified
         subjects affected / exposed
    20 / 156 (12.82%)
    19 / 150 (12.67%)
         occurrences all number
    24
    21
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number exposed includes only patients who underwent surgery (284).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number exposed includes only patients who underwent surgery (284).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number exposed includes only patients who underwent surgery (284).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number exposed includes only patients who underwent surgery (284).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number exposed includes only patients who underwent surgery (284).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number exposed includes only patients who underwent surgery (284).
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number exposed includes only patients who underwent surgery (284).
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number exposed includes only patients who underwent surgery (284).
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number exposed includes only patients who underwent surgery (284).

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Oct 2016
    Amendment 1: Extension if recruitment period, Staff changes
    11 Jul 2019
    Amendment 2: Change of the CRO

    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.
    Our trial has limitations. First, there was no central pathology evaluation. Second, because pCR constituted the primary end point of the study, long-term clinical outcome was not evaluated but will be reported in the future when mature follow-up dat

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31150315
    http://www.ncbi.nlm.nih.gov/pubmed/34792531
    For support, Contact us.
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