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    Clinical Trial Results:
    Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.

    Summary
    EudraCT number
    		 2008-005798-36
    Trial protocol
    		 NL   BE  
    Global end of trial date
    04 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2024
    First version publication date
    12 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HOVON100ALL/EORTC06083
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HOVON
    Sponsor organisation address
    Dr. Molenwaterplein 40, Rotterdam, Netherlands,
    Public contact
    Clinical Trial Center, HDC, HOVON, +31 (0)107041560, hdc@erasmusmc.nl
    Scientific contact
    Clinical Trial Center, HDC, HOVON, +31 (0)107041560, hdc@erasmusmc.nl
    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
    23 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase II part - To determine the feasibility of adding i.v. clofarabine to standard prephase therapy (followed by induction chemotherapy) Phase III part - To improve EFS in adult ALL patients by the addition of i.v. clofarabine to the standard prephase and consolidation therapy
    Protection of trial subjects
    Monitoring and Insurance
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Oct 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 308
    Country: Number of subjects enrolled
    Belgium: 64
    Country: Number of subjects enrolled
    France: 4
    Worldwide total number of subjects
    376
    EEA total number of subjects
    376
    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)
    350
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All subjects gave written informed consent and were screened according to the inclusion- and exclusion criteria

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Predniso(lo)ne 60 mg/m2, divided in 2 daily doses p.o. 1-7

    Arm title
    		 Clofarabine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clofarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    At study start, patients are assigned to a dose level Clofarabine of 20 mg/m2 /day (x5), if randomized for arm B. If this dose is not feasible according to the decision rules as described in section 17, the dose of clofarabine to be randomized for will be reduced to 15 mg/m2 /day (x5). If the dose of 20 mg/m2 /day (x5) is feasible, the dose is increased to 30 mg/m2 /day (x5). Depending on the advice of the DSMB, the dose of clofarabine will be decreased or increased.

    Number of subjects in period 1
    		Control group Clofarabine
    Started
    187
    189
    Completed
    111
    101
    Not completed
    76
    88
         Adverse events, all combined
    13
    25
         Other
    12
    19
         At patients request
    1
    1
         Lack of efficacy
    50
    43

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 376 376
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 376 376
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 42 (18 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 151 151
        Male
    		 225 225

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 -

    Reporting group title
    Clofarabine
    Reporting group description
    		 -

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint [1]
    End point description
    End point type
    Primary
    End point timeframe
    See publication
    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: See attached chart/documents for results
    End point values
    		 Control group Clofarabine
    Number of subjects analysed
    187
    189
    Units: Whole
    187
    189
    Attachments
    		 Untitled (Filename: nonsaedata100-19Dec2023.pdf)
    Untitled (Filename: HO100_Statistical data section form publication_220222.pdf)
    Untitled (Filename: saedata100-19Dec2023.pdf)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1Z97X3840472674552Serious Adverse Events (SAEs) will be reported from the first study-related procedure until 30 days following the last protocol treatment or until the start of subsequent systemic therapy for the disease under study, if earlier.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 -

    Reporting group title
    Experimental clofarabine
    Reporting group description
    		 -

    Serious adverse events
    		 Control group Experimental clofarabine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    112 / 186 (60.22%)
    142 / 188 (75.53%)
         number of deaths (all causes)
    78
    72
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Admission based on ebv lymfoproliferative disorder
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Neoplasm malignant
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    EBV + lymphomatoid granulomatosis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Thromboembolic event, pulmonary embolism
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bleeding
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Collaps
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    2 / 186 (1.08%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prolonged clotting times (PT/aPTT)
    alternative dictionary used: MedDRA 3
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thromboembolic event
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    2 / 186 (1.08%)
    4 / 188 (2.13%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombus mass in the right jugular vein &inf vena subclavion
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cholecystectomy
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nefrectomy left
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         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
    Death
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Death nos
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Extravasation
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    9 / 186 (4.84%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    3 / 10
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever (not neutropenic)
         subjects affected / exposed
    2 / 186 (1.08%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever e.c.i
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of strength in both legs
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 186 (0.54%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    3 / 186 (1.61%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucositis
         subjects affected / exposed
    5 / 186 (2.69%)
    5 / 188 (2.66%)
         occurrences causally related to treatment / all
    5 / 6
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pain thorax
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Edema
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    AGvHD
         subjects affected / exposed
    2 / 186 (1.08%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    GHVD
         subjects affected / exposed
    5 / 186 (2.69%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Allergic reaction
         subjects affected / exposed
    0 / 186 (0.00%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GvHD skin
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         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
    Peri-engraftment respiratory distress syndrome
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonthorax
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (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
    3 / 186 (1.61%)
    3 / 188 (1.60%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory insufficiency
         subjects affected / exposed
    3 / 186 (1.61%)
    5 / 188 (2.66%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 5
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Lung embolism
         subjects affected / exposed
    0 / 186 (0.00%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary hemorrage
         subjects affected / exposed
    0 / 186 (0.00%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnea
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxemia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusion
         subjects affected / exposed
    2 / 186 (1.08%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mood alteration: depression
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychosis
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    ASAT/ALAT elevation
         subjects affected / exposed
    1 / 186 (0.54%)
    3 / 188 (1.60%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood/billirubin increased
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GGT increased
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Increased liver enzymes
         subjects affected / exposed
    1 / 186 (0.54%)
    3 / 188 (1.60%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme disorder
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases elevated
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Allergic reaction on trombocyte transfusion
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Morfine-intoxication
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporotic vertebral collapse
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Second osteoporotic fracture
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural hematoma bilateral
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CNS hemorrhage
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation pneumonitis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spontaneous rupture of the spleen
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcapital fracture left hip
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access complication
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocard infarction
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest seizure
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    CVA
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral thrombosis
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Consvulsive syncope
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Critical illness neuropathy (motor-neuropathy)
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug toxicity
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 186 (0.54%)
    7 / 188 (3.72%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischemia cerebrovascular
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorder transient cerebral dysfunction
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological symptoms
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 186 (1.08%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus thrombosis
         subjects affected / exposed
    2 / 186 (1.08%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasovagal episode
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute serotenergic syndrome
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insult
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Admission for dizziness
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CSF leak
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral encephalopathy
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cortical vein thrombosis (left)
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic cranial hypertension
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periferal motor tremor neuropathy (PNP)
         subjects affected / exposed
    0 / 186 (0.00%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    0 / 186 (0.00%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular syndrome
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stroke (heamorrhagic)
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Coagulopathy
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    11 / 186 (5.91%)
    14 / 188 (7.45%)
         occurrences causally related to treatment / all
    11 / 11
    14 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemolytic anemia
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic fever
         subjects affected / exposed
    7 / 186 (3.76%)
    10 / 188 (5.32%)
         occurrences causally related to treatment / all
    6 / 7
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subfebrile neutropenia
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anemia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile non-neutropenia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 186 (0.00%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal perforation
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pancreatitis
         subjects affected / exposed
    2 / 186 (1.08%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 186 (1.08%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis, infectious
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    3 / 186 (1.61%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhea
         subjects affected / exposed
    4 / 186 (2.15%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Distal ileitis
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hematemesis
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemorrhagic gastritis
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea vomiting
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea, throw up
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction colon
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral mucositis
         subjects affected / exposed
    2 / 186 (1.08%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral mucositis grade 3
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 186 (0.54%)
    3 / 188 (1.60%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 186 (1.61%)
    4 / 188 (2.13%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingivostomatitis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus/ileum
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomach antral vascular ectasia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug induced stomatitis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastro intestinal bleeding
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    High esophageal ulceration
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal mucositis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischemic colitis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left sacro ileitis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucocutaneous ulcer small intestine
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         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 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal reflux
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paralytic ileus
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post punctional pain
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis and ulcerative oesophagitis with herpes infection
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecycstitis (acalculeuze)
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    2 / 186 (1.08%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hepatic impairment
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic veno-occlusive disease
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function disorder
         subjects affected / exposed
    1 / 186 (0.54%)
    7 / 188 (3.72%)
         occurrences causally related to treatment / all
    1 / 1
    6 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug induced hepatitis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatoxicity
         subjects affected / exposed
    0 / 186 (0.00%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver failure
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash/desquamation
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         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 renal insufficiency
         subjects affected / exposed
    3 / 186 (1.61%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute renal toxicity
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney failure
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney stone
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction ureter urolithiase
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle pain
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Backpain
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 186 (0.00%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain hip
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain right flank
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Airway infection
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteremia (Enterobacter cloacae)
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CVL infection (Hickman)
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter related infection
         subjects affected / exposed
    2 / 186 (1.08%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter sepsis
         subjects affected / exposed
    2 / 186 (1.08%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis orbita sinistra
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental infection
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    E. Coli sepsis
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal infection
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastro enteritis
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HHV6 pneumonia
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Infection
         subjects affected / exposed
    2 / 186 (1.08%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection (CVC with normal ANC)
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection candida
         subjects affected / exposed
    1 / 186 (0.54%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection catheter related
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection - wound (retrosternal)
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection wound (retrosternal)
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection catheter related (CVC)
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection e.c.i.
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection gastrointestinal (norovirus)
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection grade 4 ANC
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection normal ANC
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection skin: erysipelas
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection with normal ANC general: blood and pleural
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection urinary tract
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Opportunistic infection (oesophagus)
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PJP infection
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 186 (2.15%)
    11 / 188 (5.85%)
         occurrences causally related to treatment / all
    4 / 5
    11 / 13
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pulmonal aspergillus infection
         subjects affected / exposed
    1 / 186 (0.54%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Respiratory infection
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rota virus infection
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis with pseudomonas aeruginosa
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    3 / 186 (1.61%)
    5 / 188 (2.66%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 6
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylodiscitis
         subjects affected / exposed
    2 / 186 (1.08%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory infection
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (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
         subjects affected / exposed
    2 / 186 (1.08%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection with grade 4 neutrophils
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perianal abscess
         subjects affected / exposed
    0 / 186 (0.00%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicular abcess
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CMV reactivation
         subjects affected / exposed
    0 / 186 (0.00%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CNS bacteriamia
         subjects affected / exposed
    0 / 186 (0.00%)
    3 / 188 (1.60%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    E coli urinary tract infection and e faecalis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    E.coli bacterimia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia coli sepsis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 186 (0.00%)
    4 / 188 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Herpes simplex infection
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection candidaemia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection central venous catheter
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection lung pneumocystis jirovecii
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucormycosis (zymycosis) of sinus
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pansinusitis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcus pneumonia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytical virus infection
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    S.aureus bacteremia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic arthritis at right sacroiliac joint
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcus epidermidis septicemia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral pulmonary infection
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glucose intolerance
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 186 (0.54%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatremia
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorexia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypesthesia lower body
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalemia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control group Experimental clofarabine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    177 / 186 (95.16%)
    182 / 188 (96.81%)
    Vascular disorders
    Vascular disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    55 / 186 (29.57%)
    50 / 188 (26.60%)
         occurrences all number
    68
    55
    Surgical and medical procedures
    Surgical and medical procedures
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    3 / 186 (1.61%)
    0 / 188 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    General disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    154 / 186 (82.80%)
    171 / 188 (90.96%)
         occurrences all number
    178
    187
    General disorders and adminstration site conditions
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    175 / 186 (94.09%)
    100 / 188 (53.19%)
         occurrences all number
    185
    202
    Immune system disorders
    Immune system disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    30 / 186 (16.13%)
    12 / 188 (6.38%)
         occurrences all number
    35
    15
    Reproductive system and breast disorders
    Reproductive system and breast disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    9 / 186 (4.84%)
    3 / 188 (1.60%)
         occurrences all number
    9
    5
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    41 / 186 (22.04%)
    36 / 188 (19.15%)
         occurrences all number
    56
    63
    Investigations
    Investigations
    Additional description: All combined, see non SAE chart for details
         subjects affected / exposed
    123 / 186 (66.13%)
    24 / 188 (12.77%)
         occurrences all number
    291
    28
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    68 / 186 (36.56%)
    41 / 188 (21.81%)
         occurrences all number
    69
    49
    Nervous system disorders
    Nervous system disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    90 / 186 (48.39%)
    99 / 188 (52.66%)
         occurrences all number
    167
    192
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    72 / 186 (38.71%)
    58 / 188 (30.85%)
         occurrences all number
    90
    81
    Ear and labyrinth disorders
    Ear and labyrinth disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    9 / 186 (4.84%)
    10 / 188 (5.32%)
         occurrences all number
    9
    10
    Eye disorders
    Eye disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    21 / 186 (11.29%)
    17 / 188 (9.04%)
         occurrences all number
    26
    17
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    126 / 186 (67.74%)
    133 / 188 (70.74%)
         occurrences all number
    323
    398
    Hepatobiliary disorders
    Hepatobiliary disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    130 / 186 (69.89%)
    122 / 188 (64.89%)
         occurrences all number
    584
    658
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    77 / 186 (41.40%)
    96 / 188 (51.06%)
         occurrences all number
    101
    111
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    18 / 186 (9.68%)
    28 / 188 (14.89%)
         occurrences all number
    22
    32
    Endocrine disorders
    Endocrine disorders
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    19 / 186 (10.22%)
    40 / 188 (21.28%)
         occurrences all number
    19
    40
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    25 / 186 (13.44%)
    31 / 188 (16.49%)
         occurrences all number
    35
    41
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    123 / 186 (66.13%)
    143 / 188 (76.06%)
         occurrences all number
    291
    419
    Metabolism and nutrition disorders
    Metabolims and nutrition disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    128 / 186 (68.82%)
    137 / 188 (72.87%)
         occurrences all number
    865
    1003

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Feb 2011
    Amendment nr. 4 was a substantial protocol amendment concerning: - small adjustments to the treatment - update of SAE chapter - addition of MRD time point
    30 Nov 2011
    Amendment nr. 6 was a substantial protocol amendment concerning: -addition of nadroparine prophylaxis to protocol treatment -- addition side study coagulation NL
    20 May 2014
    Amendment nr. 13 was a substantial protocol amendment concerning: - Change of PI prof. dr. J. Cornelissen to dr. A.W. Rijneveld - The designation of pharmaceuticals companies is adjusted - General clarifications of text throughout the protocol

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34883506
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