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    Clinical Trial Results:
    Subcutaneous Rituximab and Intravenous Bendamustine in very Elderly Patients or Elderly Medically Non Fit Patients("slow go") with Aggressive CD-20-positive B-cell Lymphoma Short tiltle: BRENDA

    Summary
    EudraCT number
    		 2010-024004-98
    Trial protocol
    		 DE  
    Global end of trial date
    02 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Aug 2020
    First version publication date
    06 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DSHNHL2010-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsmedizin der Georg-August-Universität Göttingen
    Sponsor organisation address
    Robert-Koch-Straße 40, Göttingen, Germany, 37075
    Public contact
    Kristina Wilhelm, iOMEDICO AG, 0049 76115242523, kristina.wilhelm@iomedico.com
    Scientific contact
    Kristina Wilhelm, iOMEDICO AG, 0049 76115242523, kristina.wilhelm@iomedico.com
    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
    02 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary aim is to determine the feasibility, toxicity and efficacy of RB in very elderly patients or elderly medically non fit patients As no standard treatment exists, a phase II trial is an appropriate approach to define safety and efficacy of rituximab and bendamustine. The evaluation of safety and toxicity includes the following:  Toxicity, graded according to NCI-CTC version 4.03.,  Adverse events,  Serious adverse events (SAE), and SUSAR  Protocol adherence Efficacy is determined according to the 2 year-rate of progression-free-survival. Secondary aims of this study are the determination of 2 year-rate of overall survival (OS), rate of complete (CR), partial remission (PR) and rate of primary progression (PRO), relapse rate, treatment-related deaths, 2 year-rate of event free survival EFS, safety, protocol adherence (according to 4.3.1.3) , ability for self-care and quality of life (QoL) assessed by a GA (geriatric assessment) and EORTC-QLQ-C30.
    Protection of trial subjects
    The aim of the B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of bendamustine and rituximab in old patients or in elderly patients with high comorbidity who do not qualify for a CHOP like treatment. However, most of the patients included in this clinical trial will die of disease progression within weeks of diagnosis. As the RB-regimens is less toxic than the R-CHOP regimen in patients with follicular lymphoma, it can be expected to be safer for non-fit patients with DLBCL. As it demonstrated some activity in patients with recurrent or relapsed aggressive lymphoma, the use in first line treatment is justified. Safety analysis will be performed on a regular basis. For the first patients treated in the main-phase of the study (patients 21 to 31), before signing the informed consent, the treating physicians has to check whether an inclusion of the patient is possible, as patient 21 to 31 will be included sequentially with a minimum of an one-week interval between each patient. In this phase of the trial, the centers will be informed by the sponsor regularly about the actual status of the study.
    Background therapy
    		 The trial treatment started with a pre-phase treatment including one application of intravenous rituximab, followed by 3 cycles of rituximab and bendamustine (BR) every 3 weeks. Thereafter, patients were restaged based on the treatment response.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 68
    Worldwide total number of subjects
    68
    EEA total number of subjects
    68
    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)
    1
    From 65 to 84 years
    50
    85 years and over
    17

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with a newly diagnosed CD20+ aggressive lymphoma aged ≽ 81 years as well as patients aged 61 to 80 with comorbidities not qualifying for CHOP chemotherapy, regardless of gender or disease stage. PS-ECOG <4 with life expectancy of at least 6 weeks, when lymphoma is treated. 24 German recruiting hospitals between July 2012 and Feb. 2016.

    Pre-assignment
    Screening details
    		 For the Run-in phase, 21 patients screened with one screening failure.

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

    Arms
    Arm title
    		 run-in and main phase
    Arm description
    		 Run-in phase Patients 1 to 20 Pre-phase: Prednisolone 100 mg absolute p.o. day -7 to -1 Rituximab 375 mg/m² body surface area IV d-3 Trial treatment: Cycles 1 to 7: Rituximab 375 mg /m² body surface area IV day 1, every 3 weeks Cycles 1 to 6: Bendamustine 90 mg /m² body surface area IV day 1 and 2 (or day 2 and 3 at investigators decision), every 3 weeks Main-Phase Patients 21 up to the end of recruitment (after the analysis of the Safety Data by the DSMB for the first 20 patients and of the Rituximab SC Data available from ongoing studies at that timepoint). The first 10 patients of the main-phase will be recruited sequentially on a minimal weekly basis Pre-phase: Prednisolone 100 mg absolute p.o. day -7 to -1 Rituximab 375 mg/m² body surface area IV d-3 Trial treatment: Cycles 1 to 7: Rituximab SC 1400 mg absolute day 1, every 3 weeks Cycles 1 to 6: Bendamustine 90 mg /m² body surface area IV day 1 and 2 (or day 2 and 3 at investigators decision), eve
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    LEVACT®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients receiving bendamustine will be administered at a dose of 90 mg/m². The recommended infusion time is 30 to 60 minutes. The prepared bendamustine solution should be administered as an intravenous infusion through a dedicated line. It should not be administered as an intravenous push or bolus.

    Investigational medicinal product name
    Rituximab IV
    Investigational medicinal product code
    Other name
    Mabthera i.v.®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients receiving rituximab IV will be administered a dose of 375 mg/m². The appropriate amount of solution should be withdrawn from the vial from the following calculation: Volume (ml) = BSA (m²) * dose (375 mg/m²) / concentration of reconstituted solution mg/ml (100 mg/10 ml and/or 500 mg/50 ml) The recommended initial rate for infusion is 50 mg/hour; after the first 30 minutes, it can be escalated in 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hour. Subsequent doses of rituximab IV can be infused at an initial rate of 100 mg/hour, and increased by 100 mg/hour increments at 30 minutes intervals, to a maximum of 400 mg/hour. The prepared rituximab IV solution should be administered as an intravenous infusion through a dedicated line. It should not be administered as an intravenous push or bolus

    Investigational medicinal product name
    Rituximab s.c.
    Investigational medicinal product code
    Other name
    MabThera SC, Rituxan SC
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Main-Phase Patients 21 up to the end of recruitment (after the analysis of the Safety Data by the DSMB for the first 20 patients and of the Rituximab SC Data available from ongoing studies at that timepoint). The first 10 patients of the main-phase will be recruited sequentially on a minimal weekly basis Pre-phase: Prednisolone 100 mg absolute p.o. day -7 to -1 Rituximab 375 mg/m² body surface area IVd-3 Trial treatment: Cycles 1 to 7: Rituximab SC 1400 mg absolute day 1, every 3 weeks Cycles 1 to 6: Bendamustine 90 mg /m² body surface area IV day 1 and 2 (or day 2 and 3 at investigators decision), every 3 weeks G-CSF according to ASCO/ESMO guidelines

    Number of subjects in period 1
    		run-in and main phase
    Started
    68
    Completed
    68

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 Patients 1 to 20 Pre-phase: Prednisolone 100 mg absolute p.o. day -7 to -1 Rituximab 375 mg/m2 body surface area IV d-3 Trial treatment: Cycles 1 to 7: Rituximab 375 mg /m2 body surface area IV day 1, every 3 weeks Cycles 1 to 6: Bendamustine 90 mg /m2 body surface area IV day 1 and 2 (or day 2 and 3 at investigators decision), every 3 weeks Main-Phase Patients 21 to 68. The first 10 patients of the main-phase will be recruited sequentially on a minimal weekly basis Pre-phase: Prednisolone 100 mg absolute p.o. day -7 to -1 Rituximab 375 mg/m² body surface area IV d-3 Trial treatment: Cycles 1 to 7: Rituximab SC 1400 mg absolute day 1, every 3 weeks Cycles 1 to 6: Bendamustine 90 mg /m² body surface area IV day 1 and 2 (or day 2 and 3 at investigators decision), every 3 weeks G-CSF according to ASCO/ESMO guidelines

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 68 68
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 50 50
        85 years and over
    		 17 17
    Gender categorical
    Units: Subjects
        Female
    		 46 46
        Male
    		 22 22
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all registered patients

    Subject analysis set title
    FAS-I
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    patients > 80 years

    Subject analysis set title
    FAS-II
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    patients 61 - 80 years

    Subject analysis set title
    Per Protocol Set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from FAS with fulfilled inclusion criteria and reference pathology according to protocol and at least on dose Rituximab and/or Bendamustine.

    Subject analysis set title
    PPS-I
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    patients > 80 years

    Subject analysis set title
    PPS-II
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    patients 61 - 80 years

    Subject analysis sets values
    		 Full Analysis Set (FAS) FAS-I FAS-II Per Protocol Set (PPS) PPS-I PPS-II
    Number of subjects
    68
    39
    29
    57
    34
    23
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    1
    0
    1
    1
    0
    1
        From 65-84 years
    50
    22
    28
    40
    18
    22
        85 years and over
    17
    17
    0
    16
    16
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    46
    28
    18
    38
    24
    14
        Male
    22
    11
    11
    19
    10
    9

    End points

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    End points reporting groups
    Reporting group title
    run-in and main phase
    Reporting group description
    		 Run-in phase Patients 1 to 20 Pre-phase: Prednisolone 100 mg absolute p.o. day -7 to -1 Rituximab 375 mg/m² body surface area IV d-3 Trial treatment: Cycles 1 to 7: Rituximab 375 mg /m² body surface area IV day 1, every 3 weeks Cycles 1 to 6: Bendamustine 90 mg /m² body surface area IV day 1 and 2 (or day 2 and 3 at investigators decision), every 3 weeks Main-Phase Patients 21 up to the end of recruitment (after the analysis of the Safety Data by the DSMB for the first 20 patients and of the Rituximab SC Data available from ongoing studies at that timepoint). The first 10 patients of the main-phase will be recruited sequentially on a minimal weekly basis Pre-phase: Prednisolone 100 mg absolute p.o. day -7 to -1 Rituximab 375 mg/m² body surface area IV d-3 Trial treatment: Cycles 1 to 7: Rituximab SC 1400 mg absolute day 1, every 3 weeks Cycles 1 to 6: Bendamustine 90 mg /m² body surface area IV day 1 and 2 (or day 2 and 3 at investigators decision), eve

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all registered patients

    Subject analysis set title
    FAS-I
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    patients > 80 years

    Subject analysis set title
    FAS-II
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    patients 61 - 80 years

    Subject analysis set title
    Per Protocol Set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients from FAS with fulfilled inclusion criteria and reference pathology according to protocol and at least on dose Rituximab and/or Bendamustine.

    Subject analysis set title
    PPS-I
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    patients > 80 years

    Subject analysis set title
    PPS-II
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    patients 61 - 80 years

    Primary: 2 years progression-free survival

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    End point title
    		 2 years progression-free survival
    End point description
    End point type
    Primary
    End point timeframe
    until 2 years after end-of-treatment
    End point values
    		 run-in and main phase Full Analysis Set (FAS) FAS-I FAS-II Per Protocol Set (PPS) PPS-I PPS-II
    Number of subjects analysed
    68
    68
    39
    29
    57
    34
    23
    Units: number of patients
    68
    29
    18
    11
    23
    16
    7
    Statistical analysis title
    		 overall study analysis
    Comparison groups
    run-in and main phase v Full Analysis Set (FAS) v FAS-I v FAS-II v Per Protocol Set (PPS) v PPS-I v PPS-II
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 multivariante analysis
    Confidence interval

    Primary: therapy-associated deaths

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    End point title
    		 therapy-associated deaths
    End point description
    End point type
    Primary
    End point timeframe
    until end-of-study
    End point values
    		 run-in and main phase Full Analysis Set (FAS) FAS-I FAS-II Per Protocol Set (PPS) PPS-I PPS-II
    Number of subjects analysed
    68
    68
    39
    29
    57
    34
    23
    Units: number of patients
    68
    10
    5
    5
    9
    4
    5
    Statistical analysis title
    		 overall study analysis
    Comparison groups
    run-in and main phase v Full Analysis Set (FAS) v FAS-I v FAS-II v Per Protocol Set (PPS) v PPS-I v PPS-II
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 multivariante analysis
    Confidence interval

    Primary: frequency of grade 3 to 5 adverse events and SAEs

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    End point title
    		 frequency of grade 3 to 5 adverse events and SAEs
    End point description
    End point type
    Primary
    End point timeframe
    until end of study
    End point values
    		 run-in and main phase Full Analysis Set (FAS) FAS-I FAS-II
    Number of subjects analysed
    68
    68
    39
    29
    Units: number
    68
    137
    76
    61
    Statistical analysis title
    		 overall study analysis
    Comparison groups
    run-in and main phase v Full Analysis Set (FAS) v FAS-I v FAS-II
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 multivariante analysis
    Confidence interval

    Primary: adherence to the protocol

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    End point title
    		 adherence to the protocol
    End point description
    End point type
    Primary
    End point timeframe
    until end-of-treatment
    End point values
    		 run-in and main phase Full Analysis Set (FAS) FAS-I FAS-II
    Number of subjects analysed
    68
    68
    39
    29
    Units: number of patients
    68
    33
    22
    11
    Statistical analysis title
    		 overall study analysis
    Comparison groups
    run-in and main phase v Full Analysis Set (FAS) v FAS-I v FAS-II
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 multivariante analysis
    Confidence interval

    Secondary: 2 years overall survival (OS)

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    End point title
    		 2 years overall survival (OS)
    End point description
    End point type
    Secondary
    End point timeframe
    until end-of-trial
    End point values
    		 run-in and main phase Full Analysis Set (FAS) FAS-I FAS-II Per Protocol Set (PPS) PPS-I PPS-II
    Number of subjects analysed
    68
    68
    39
    29
    57
    34
    23
    Units: number of patients
    68
    33
    20
    13
    25
    17
    8
    Statistical analysis title
    		 overall study analysis
    Comparison groups
    run-in and main phase v Full Analysis Set (FAS) v FAS-I v FAS-II v Per Protocol Set (PPS) v PPS-I v PPS-II
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 multivariante analysis
    Confidence interval

    Secondary: event-free-survival (EFS)

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    End point title
    		 event-free-survival (EFS)
    End point description
    End point type
    Secondary
    End point timeframe
    until end-of-trial
    End point values
    		 run-in and main phase Full Analysis Set (FAS) FAS-I FAS-II Per Protocol Set (PPS) PPS-I PPS-II
    Number of subjects analysed
    68
    68
    39
    29
    57
    34
    23
    Units: number of patients
    68
    16
    13
    3
    15
    12
    3
    Statistical analysis title
    		 overall study analysis
    Comparison groups
    run-in and main phase v Full Analysis Set (FAS) v FAS-I v FAS-II v Per Protocol Set (PPS) v PPS-I v PPS-II
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 multivariante analysis
    Confidence interval

    Secondary: complete remission rate (CR)

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    End point title
    		 complete remission rate (CR)
    End point description
    End point type
    Secondary
    End point timeframe
    until end-of-trial
    End point values
    		 run-in and main phase Full Analysis Set (FAS) FAS-I FAS-II Per Protocol Set (PPS) PPS-I PPS-II
    Number of subjects analysed
    68
    68
    39
    29
    57
    34
    23
    Units: number of patients
    21
    21
    18
    3
    20
    17
    3
    Statistical analysis title
    		 overall study analysis
    Comparison groups
    run-in and main phase v Full Analysis Set (FAS) v FAS-I v FAS-II v Per Protocol Set (PPS) v PPS-I v PPS-II
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 multivariante analysis
    Confidence interval

    Secondary: partial remission rate (PR)

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    End point title
    		 partial remission rate (PR)
    End point description
    End point type
    Secondary
    End point timeframe
    until end-of-study
    End point values
    		 run-in and main phase Full Analysis Set (FAS) FAS-I FAS-II Per Protocol Set (PPS) PPS-I PPS-II
    Number of subjects analysed
    68
    68
    39
    29
    57
    34
    23
    Units: number of patients
    68
    7
    2
    5
    5
    2
    3
    Statistical analysis title
    		 overall study analysis
    Comparison groups
    run-in and main phase v Full Analysis Set (FAS) v FAS-I v FAS-II v Per Protocol Set (PPS) v PPS-I v PPS-II
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 multivariante analysis
    Confidence interval

    Secondary: rate of primary progression (PD)

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    End point title
    		 rate of primary progression (PD)
    End point description
    End point type
    Secondary
    End point timeframe
    until end-of-study
    End point values
    		 run-in and main phase Full Analysis Set (FAS) FAS-I FAS-II Per Protocol Set (PPS) PPS-I PPS-II
    Number of subjects analysed
    68
    68
    39
    29
    57
    34
    23
    Units: number of patients
    68
    13
    5
    8
    9
    3
    6
    Statistical analysis title
    		 overall study analysis
    Comparison groups
    run-in and main phase v Full Analysis Set (FAS) v FAS-I v FAS-II v Per Protocol Set (PPS) v PPS-I v PPS-II
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 multivariante analysis
    Confidence interval

    Secondary: relapse rate at end of therapy

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    End point title
    		 relapse rate at end of therapy
    End point description
    End point type
    Secondary
    End point timeframe
    until end-of-study
    End point values
    		 run-in and main phase Full Analysis Set (FAS) FAS-I FAS-II Per Protocol Set (PPS) PPS-I PPS-II
    Number of subjects analysed
    68
    21
    18
    3
    20
    17
    3
    Units: number
    68
    2
    2
    0
    2
    2
    0
    Statistical analysis title
    		 overall study analysis
    Comparison groups
    run-in and main phase v Full Analysis Set (FAS) v FAS-I v FAS-II v Per Protocol Set (PPS) v PPS-I v PPS-II
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 ≤ 0.05
    Method
    		 multivariante analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    complete study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTC
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    complete study
    Reporting group description
    		 -

    Serious adverse events
    		 complete study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    47 / 68 (69.12%)
         number of deaths (all causes)
    35
         number of deaths resulting from adverse events
    15
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal cancer
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    fever
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    General physical condition abnormal
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Multi-organ disorder
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Dyspnoea
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Creatinine urine increased
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ventricular failure
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac dysfunction
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    Nervous system disorders
    Syncope
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Cytopenia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroparesis postoperative
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Perforation
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Obstruction
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Obstruction
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    2 / 3
    Infection
         subjects affected / exposed
    6 / 68 (8.82%)
         occurrences causally related to treatment / all
    5 / 7
         deaths causally related to treatment / all
    0 / 2
    Pneumonia
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences causally related to treatment / all
    6 / 12
         deaths causally related to treatment / all
    0 / 3
    Cystitis
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anorexia nervosa
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 complete study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    68 / 68 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    7 / 68 (10.29%)
         occurrences all number
    10
    hypertensive crisis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    hypotension
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Thrombophlebitis
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences all number
    3
    haematoma coccyx
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Hematoma Abdomen
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    hematoma
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    deep vein thrombosis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    lymphedema face
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    phlebitis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    11 / 68 (16.18%)
         occurrences all number
    27
    fever
         subjects affected / exposed
    12 / 68 (17.65%)
         occurrences all number
    18
    edema
         subjects affected / exposed
    7 / 68 (10.29%)
         occurrences all number
    23
    weakness
         subjects affected / exposed
    6 / 68 (8.82%)
         occurrences all number
    8
    reduced general condition
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    4
    Pain
         subjects affected / exposed
    8 / 68 (11.76%)
         occurrences all number
    15
    Paravasat
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    7
    Mucositis
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    5
    Malaise
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Hematoma at port
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Chills
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences all number
    8
    infusion site extravasation
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    port infection
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    bleeding ulcus
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    tumefaction on injection site
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Gait disturbance
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Immune system disorders
    allergic reaction
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences all number
    3
    Reproductive system and breast disorders
    pain in breast
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    BPH
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences all number
    5
    Dyspnoea
         subjects affected / exposed
    8 / 68 (11.76%)
         occurrences all number
    20
    Cough
         subjects affected / exposed
    7 / 68 (10.29%)
         occurrences all number
    12
    sore throat
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Shortness of breath
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    throat pain
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    Bronchospasmus
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    rhinorrhea
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences all number
    13
    Confusion
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    4
    Restlessness
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    5
    Depression
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences all number
    3
    Anxiety
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    disorientation
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Agitation
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    disorders of sleep
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    halluzination
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    aggression due to steroide
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    discomposure
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Investigations
    creatinine increased
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    Weight loss
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    9
    LDH increased
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    increase of hypertension
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    GGT increased
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    Vitamin D shortage
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    PTT increased
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    AP increased
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    C-reactive protein increase
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Erythrocyte sedimentation rate increased
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    CRP increase
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences all number
    7
    Fracture
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    4
    biceps tendon rupture
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    pain (intermittent, after fall)
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Cardiac disorders
    Tachyarrhythmia
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences all number
    3
    Tachycardia
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    5
    Atrial fibrillation
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    3
    Bradycardia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    pectangiose pain
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    cardiac decompensation
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    left ventricular systolic dysfunction
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    pericardial effusion
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    paroxysmal atrial flutter
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    palpitations
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    NYHA
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    heart pain
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    TAA
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    cardiac disorders
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    15
    Syncope
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    Paresthesia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    trembling
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Polyneuropathy
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    Loss of the smell
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Taste alteration
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    anomia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Tingling in the lower legs and feet
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    foot flexor paresis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    balance disorder
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    giddiness
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    6 / 68 (8.82%)
         occurrences all number
    7
    Leucopenia
         subjects affected / exposed
    6 / 68 (8.82%)
         occurrences all number
    42
    Anaemia
         subjects affected / exposed
    6 / 68 (8.82%)
         occurrences all number
    29
    Thrombocytopenia
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    7
    Lymphocytopenia
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    4
    Pancytopenia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Coagulation disorder
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences all number
    5
    Aural disturbances
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    hypakousis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    hearing impaired
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Eye disorders
    reduced visus
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    sight disorder
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    decreased vision
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    eye fibrillation
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Gastrointestinal disorders
    Obstipation
         subjects affected / exposed
    6 / 68 (8.82%)
         occurrences all number
    8
    Nausea
         subjects affected / exposed
    11 / 68 (16.18%)
         occurrences all number
    42
    Vomiting
         subjects affected / exposed
    8 / 68 (11.76%)
         occurrences all number
    19
    Diarrhoea
         subjects affected / exposed
    12 / 68 (17.65%)
         occurrences all number
    24
    Constipation
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences all number
    11
    Abdominal pain
         subjects affected / exposed
    9 / 68 (13.24%)
         occurrences all number
    11
    Colitis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    Stomatitis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    Gastritis
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences all number
    3
    low-grade inflammation in mouth
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    flatulence
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    heartburn
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    emesis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    oesophagitis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Fecal incontinence
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Dry mouth
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Hernia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    Dysphagia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    incomplete intestinal obstruction
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    sweat
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    5
    suggilation
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    erythema
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    itching
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Exanthema due to medication
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Ulcus right lower leg
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Petechiae
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    itching small-sized scaling Eczema left mamma
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    alopecia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    rash intermittent
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    suspected Dermal eczema
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Renal and urinary disorders
    prerenal kidney failure
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    urinary tract obstruction
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    Incontinence
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    acute renal failure
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Pollakiuria
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    nykturia
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    leukocyturia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Dysuria
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    light burining while urination
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Renal Toxicity
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Endocrine disorders
    Hyperthyreose
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    hyperthyreodism
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Hypothyroidism
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    6 / 68 (8.82%)
         occurrences all number
    16
    Osteoporosis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    weakness
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    3
    muscle hypothrophy
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    swollen joint
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    gonarthrosis right
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Joint range of motion decreased - left shoulder
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    7 / 68 (10.29%)
         occurrences all number
    15
    bronchitis
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    3
    Infection
         subjects affected / exposed
    6 / 68 (8.82%)
         occurrences all number
    13
    Herpes
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences all number
    5
    soor
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    4
    Cold
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Mycosis
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences all number
    3
    Gastroenteritis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Erysipelas
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    Candida infection
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    10 / 68 (14.71%)
         occurrences all number
    30
    loss of appetite
         subjects affected / exposed
    5 / 68 (7.35%)
         occurrences all number
    12
    Anorexia
         subjects affected / exposed
    4 / 68 (5.88%)
         occurrences all number
    9
    tumorlysis syndrom
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    exsiccosis
         subjects affected / exposed
    3 / 68 (4.41%)
         occurrences all number
    5
    Dehydration
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    cancer cachexia - weight loss
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    tumor lysis syndrom
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Hypocalcaemia
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    hypovitaminosis
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    electrolyte imbalance
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    malnutrition
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    lack of protein
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    2
    Hyperuricaemia
         subjects affected / exposed
    2 / 68 (2.94%)
         occurrences all number
    2
    Hyponatraemia
         subjects affected / exposed
    1 / 68 (1.47%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2013
    Changes for the main phase 2 of the trial (from patient 21) due to additional requested information by the Ethic committee during approval process
    20 Apr 2015
    - Reduction of planned number of patients (from 100 to 77 patients) to recruit for the study - Prolongation of recruitment time - Number of sites reduced
    18 Aug 2017
    Deletion of the interim analysis, due to premature termination of recruitment.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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