Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCT

    Summary
    EudraCT number
    		 2013-003621-28
    Trial protocol
    		 GB   BE   SE   ES   IT   DE   NL   FR  
    Global end of trial date
    08 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Oct 2021
    First version publication date
    01 Oct 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CA209-139
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    19 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the clinical benefit of nivolumab, as measured by independent radiologic review committee (IRRC) assessed objective response rate (ORR) in subjects with Diffuse Large B-Cell Lymphoma (DLBCL) who are refractory or have relapsed following Autologous Stem Cell Transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in ASCT ineligible patients.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 2014
    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
    Australia: 11
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Netherlands: 14
    Country: Number of subjects enrolled
    Singapore: 5
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    United States: 39
    Worldwide total number of subjects
    121
    EEA total number of subjects
    48
    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)
    67
    From 65 to 84 years
    52
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 121 participants entered the treatment period.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Nivolumab 3mg/kg
    Arm description
    		 Nivolumab 3mg/kg IV Q2W for participants who failed autologous stem cell transplant (ASCT) or who were ineligible for ASCT
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-936558-01 Solution for Injection
    Investigational medicinal product code
    Other name
    Nivolumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/Kg Q2W

    Number of subjects in period 1
    		Nivolumab 3mg/kg
    Started
    121
    Completed
    0
    Not completed
    121
         Participant request to discontinue treatment
    2
         Disease progression
    104
         Study drug toxicity
    6
         Adverse event unrelated to study drug
    6
         Other reasons
    2
         Lost to follow-up
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Nivolumab 3mg/kg
    Reporting group description
    		 Nivolumab 3mg/kg IV Q2W for participants who failed autologous stem cell transplant (ASCT) or who were ineligible for ASCT

    Reporting group values
    		 Nivolumab 3mg/kg Total
    Number of subjects
    		 121 121
    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)
    		 67 67
        From 65-84 years
    		 52 52
        85 years and over
    		 2 2
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.1 ( 11.96 ) -
    Sex: Female, Male
    Units:
        Female
    		 44 44
        Male
    		 77 77
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 12 12
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 5 5
        White
    		 102 102
        More than one race
    		 0 0
        Unknown or Not Reported
    		 2 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 3 3
        Not Hispanic or Latino
    		 64 64
        Unknown or Not Reported
    		 54 54
    Subject analysis sets

    Subject analysis set title
    ASCT-failed
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W

    Subject analysis set title
    ASCT-ineligible
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W

    Subject analysis sets values
    		 ASCT-failed ASCT-ineligible
    Number of subjects
    87
    34
    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)
    56
    11
        From 65-84 years
    31
    21
        85 years and over
    0
    2
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    59.1 ( 10.94 )
    66.4 ( 12.98 )
    Sex: Female, Male
    Units:
        Female
    31
    13
        Male
    56
    21
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
    0
        Asian
    11
    1
        Native Hawaiian or Other Pacific Islander
    0
    0
        Black or African American
    3
    2
        White
    71
    31
        More than one race
    0
    0
        Unknown or Not Reported
    2
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    2
    1
        Not Hispanic or Latino
    44
    20
        Unknown or Not Reported
    41
    13

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Nivolumab 3mg/kg
    Reporting group description
    		 Nivolumab 3mg/kg IV Q2W for participants who failed autologous stem cell transplant (ASCT) or who were ineligible for ASCT

    Subject analysis set title
    ASCT-failed
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W

    Subject analysis set title
    ASCT-ineligible
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W

    Primary: Objective Response Rate (ORR) per Independent Radiologic Review Committee (IRRC) assessment

    		 Close Top of page
    End point title
    		 Objective Response Rate (ORR) per Independent Radiologic Review Committee (IRRC) assessment [1]
    End point description
    ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites
    End point type
    Primary
    End point timeframe
    From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months)
    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: No statistical analyses were performed for this endpoint.
    End point values
    		 ASCT-failed ASCT-ineligible
    Number of subjects analysed
    87
    34
    Units: Percentage of participants
        number (confidence interval 95%)
    10.3 (4.8 to 18.7)
    2.9 (0.1 to 15.3)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

    		 Close Top of page
    End point title
    		 Duration of Response (DOR)
    End point description
    DOR is defined as the time from first response (Complete Response (CR) or Partial Response (PR)) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites.
    End point type
    Secondary
    End point timeframe
    From date of first response to the date of documented disease progression or death, whichever occurs first (up to approximately 18 months)
    End point values
    		 ASCT-failed ASCT-ineligible
    Number of subjects analysed
    9
    1
    Units: Months
        median (confidence interval 95%)
    11.43 (2.53 to 17.15)
    8.34 (8.34 to 99999)
    No statistical analyses for this end point

    Secondary: Complete Remission Rate

    		 Close Top of page
    End point title
    		 Complete Remission Rate
    End point description
    Complete Remission Rate is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan.
    End point type
    Secondary
    End point timeframe
    From date of first dose to study completion (up to approximately 78 months)
    End point values
    		 ASCT-failed ASCT-ineligible
    Number of subjects analysed
    87
    34
    Units: Percent of participants
        number (confidence interval 95%)
    3.4 (0.7 to 9.7)
    0 (0 to 10.3)
    No statistical analyses for this end point

    Secondary: Partial Remission Rate

    		 Close Top of page
    End point title
    		 Partial Remission Rate
    End point description
    Partial Remission rate is defined as the percentage of participants with a Best Overall Response (BOR) of Partial Response (PR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. PR= Regression of measurable disease and no emergence of new sites.
    End point type
    Secondary
    End point timeframe
    From date of first dose to study completion (up to approximately 78 months)
    End point values
    		 ASCT-failed ASCT-ineligible
    Number of subjects analysed
    87
    34
    Units: Percent of participants
        number (confidence interval 95%)
    6.9 (2.6 to 14.4)
    2.9 (0.1 to 15.3)
    No statistical analyses for this end point

    Secondary: Duration of Complete Remission

    		 Close Top of page
    End point title
    		 Duration of Complete Remission
    End point description
    The duration of Complete Remission is defined as the time from first documentation of Complete Response (CR) (which is the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow [if required], whichever occurs later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan.
    End point type
    Secondary
    End point timeframe
    From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (up approximately 14 months)
    End point values
    		 ASCT-failed ASCT-ineligible
    Number of subjects analysed
    3
    0 [2]
    Units: Months
        median (full range (min-max))
    99999 (99999 to 99999)
    ( to )
    Notes
    [2] - No subject achieved Complete Response in this cohort
    No statistical analyses for this end point

    Secondary: Duration of Partial Remission

    		 Close Top of page
    End point title
    		 Duration of Partial Remission
    End point description
    Duration of Partial Remission is defined as the time from first documentation of Partial Response (PR) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. PR= Regression of measurable disease and no emergence of new sites.
    End point type
    Secondary
    End point timeframe
    From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (up to approximately 12 months)
    End point values
    		 ASCT-failed ASCT-ineligible
    Number of subjects analysed
    6
    1
    Units: Months
        median (full range (min-max))
    6.64 (2.4 to 11.4)
    8.34 (8.34 to 8.34)
    No statistical analyses for this end point

    Secondary: Progression Free Survival

    		 Close Top of page
    End point title
    		 Progression Free Survival
    End point description
    Progression Free Survival (PFS) is defined as the time from first dosing date to the date of the first documented progression, as determined by an Independent Radiology Review Committee (IRRC) according to the 2007 revised IWG Criteria for Malignant Lymphoma, or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (up to approximately 2 months)
    End point values
    		 ASCT-failed ASCT-ineligible
    Number of subjects analysed
    87
    34
    Units: Months
        median (confidence interval 95%)
    1.87 (1.71 to 1.87)
    1.41 (1.15 to 1.81)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR) per Investigator assessment

    		 Close Top of page
    End point title
    		 Objective Response Rate (ORR) per Investigator assessment
    End point description
    ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), according to investigator assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites.
    End point type
    Secondary
    End point timeframe
    From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 28 months)
    End point values
    		 ASCT-failed ASCT-ineligible
    Number of subjects analysed
    87
    34
    Units: Percent of participants
        number (confidence interval 95%)
    19.5 (11.8 to 29.4)
    2.9 (0.1 to 15.3)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    AEs collected were reported between first dose and 100 days after last dose of study therapy.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    ASCT Ineligible
    Reporting group description
    		 Subjects who failed at least two prior multi-agent chemotherapy regimens were administered with Nivolumab 3 mg/kg solution IV every 2 weeks until progression or unacceptable toxicity.

    Reporting group title
    ASCT Failed
    Reporting group description
    		 Subjects who failed Autologous Stem Cell Transplant (ASCT) were administered with Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until progression or unacceptable toxicity.

    Serious adverse events
    		 ASCT Ineligible ASCT Failed
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 34 (79.41%)
    56 / 87 (64.37%)
         number of deaths (all causes)
    34
    64
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    5 / 34 (14.71%)
    3 / 87 (3.45%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    10 / 34 (29.41%)
    20 / 87 (22.99%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 21
         deaths causally related to treatment / all
    0 / 8
    0 / 14
    Malignant pleural effusion
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Neoplasm progression
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial pain
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Localised oedema
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dyspnoea
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung disorder
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Tibia fracture
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (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
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IIIrd nerve paralysis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Abdominal lymphadenopathy
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 34 (8.82%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye swelling
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 87 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 34 (0.00%)
    3 / 87 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal obstruction
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal perforation
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash erythematous
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 34 (2.94%)
    4 / 87 (4.60%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         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
    Back pain
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone lesion
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Morphoea
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    0 / 34 (0.00%)
    7 / 87 (8.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypercalcaemia
         subjects affected / exposed
    3 / 34 (8.82%)
    3 / 87 (3.45%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ASCT Ineligible ASCT Failed
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 34 (91.18%)
    83 / 87 (95.40%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 34 (11.76%)
    4 / 87 (4.60%)
         occurrences all number
    9
    5
    Blood creatinine increased
         subjects affected / exposed
    3 / 34 (8.82%)
    10 / 87 (11.49%)
         occurrences all number
    5
    14
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 34 (8.82%)
    3 / 87 (3.45%)
         occurrences all number
    7
    6
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 34 (8.82%)
    2 / 87 (2.30%)
         occurrences all number
    8
    2
    Blood bilirubin increased
         subjects affected / exposed
    3 / 34 (8.82%)
    0 / 87 (0.00%)
         occurrences all number
    4
    0
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 87 (3.45%)
         occurrences all number
    2
    6
    Lipase increased
         subjects affected / exposed
    0 / 34 (0.00%)
    6 / 87 (6.90%)
         occurrences all number
    0
    16
    Platelet count decreased
         subjects affected / exposed
    3 / 34 (8.82%)
    2 / 87 (2.30%)
         occurrences all number
    5
    4
    Weight decreased
         subjects affected / exposed
    0 / 34 (0.00%)
    5 / 87 (5.75%)
         occurrences all number
    0
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 34 (8.82%)
    11 / 87 (12.64%)
         occurrences all number
    3
    14
    Dizziness
         subjects affected / exposed
    1 / 34 (2.94%)
    5 / 87 (5.75%)
         occurrences all number
    1
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 34 (20.59%)
    25 / 87 (28.74%)
         occurrences all number
    19
    57
    Neutropenia
         subjects affected / exposed
    4 / 34 (11.76%)
    13 / 87 (14.94%)
         occurrences all number
    13
    22
    Thrombocytopenia
         subjects affected / exposed
    5 / 34 (14.71%)
    15 / 87 (17.24%)
         occurrences all number
    22
    37
    Leukopenia
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 87 (1.15%)
         occurrences all number
    5
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 34 (5.88%)
    6 / 87 (6.90%)
         occurrences all number
    2
    7
    Fatigue
         subjects affected / exposed
    13 / 34 (38.24%)
    36 / 87 (41.38%)
         occurrences all number
    15
    53
    Oedema peripheral
         subjects affected / exposed
    7 / 34 (20.59%)
    10 / 87 (11.49%)
         occurrences all number
    10
    13
    Pyrexia
         subjects affected / exposed
    7 / 34 (20.59%)
    22 / 87 (25.29%)
         occurrences all number
    7
    28
    Influenza like illness
         subjects affected / exposed
    0 / 34 (0.00%)
    6 / 87 (6.90%)
         occurrences all number
    0
    6
    Mucosal inflammation
         subjects affected / exposed
    0 / 34 (0.00%)
    5 / 87 (5.75%)
         occurrences all number
    0
    5
    Pain
         subjects affected / exposed
    3 / 34 (8.82%)
    3 / 87 (3.45%)
         occurrences all number
    3
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    7 / 34 (20.59%)
    10 / 87 (11.49%)
         occurrences all number
    8
    18
    Constipation
         subjects affected / exposed
    8 / 34 (23.53%)
    19 / 87 (21.84%)
         occurrences all number
    11
    21
    Diarrhoea
         subjects affected / exposed
    2 / 34 (5.88%)
    23 / 87 (26.44%)
         occurrences all number
    4
    30
    Dry mouth
         subjects affected / exposed
    2 / 34 (5.88%)
    5 / 87 (5.75%)
         occurrences all number
    2
    5
    Nausea
         subjects affected / exposed
    13 / 34 (38.24%)
    28 / 87 (32.18%)
         occurrences all number
    18
    36
    Stomatitis
         subjects affected / exposed
    1 / 34 (2.94%)
    6 / 87 (6.90%)
         occurrences all number
    1
    6
    Vomiting
         subjects affected / exposed
    3 / 34 (8.82%)
    20 / 87 (22.99%)
         occurrences all number
    4
    26
    Abdominal discomfort
         subjects affected / exposed
    0 / 34 (0.00%)
    5 / 87 (5.75%)
         occurrences all number
    0
    5
    Dysphagia
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 87 (2.30%)
         occurrences all number
    4
    2
    Abdominal distension
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 87 (1.15%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 34 (2.94%)
    21 / 87 (24.14%)
         occurrences all number
    1
    30
    Dyspnoea
         subjects affected / exposed
    2 / 34 (5.88%)
    17 / 87 (19.54%)
         occurrences all number
    3
    21
    Dyspnoea exertional
         subjects affected / exposed
    2 / 34 (5.88%)
    4 / 87 (4.60%)
         occurrences all number
    2
    4
    Pleural effusion
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 87 (2.30%)
         occurrences all number
    2
    2
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    2 / 34 (5.88%)
    6 / 87 (6.90%)
         occurrences all number
    2
    7
    Pruritus
         subjects affected / exposed
    4 / 34 (11.76%)
    5 / 87 (5.75%)
         occurrences all number
    4
    7
    Rash
         subjects affected / exposed
    2 / 34 (5.88%)
    14 / 87 (16.09%)
         occurrences all number
    3
    18
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 34 (2.94%)
    8 / 87 (9.20%)
         occurrences all number
    1
    9
    Insomnia
         subjects affected / exposed
    1 / 34 (2.94%)
    10 / 87 (11.49%)
         occurrences all number
    1
    10
    Confusional state
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 87 (2.30%)
         occurrences all number
    2
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 34 (17.65%)
    13 / 87 (14.94%)
         occurrences all number
    6
    19
    Back pain
         subjects affected / exposed
    4 / 34 (11.76%)
    9 / 87 (10.34%)
         occurrences all number
    6
    12
    Pain in extremity
         subjects affected / exposed
    4 / 34 (11.76%)
    9 / 87 (10.34%)
         occurrences all number
    4
    10
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 34 (0.00%)
    5 / 87 (5.75%)
         occurrences all number
    0
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 34 (0.00%)
    7 / 87 (8.05%)
         occurrences all number
    0
    10
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 34 (0.00%)
    9 / 87 (10.34%)
         occurrences all number
    0
    10
    Urinary tract infection
         subjects affected / exposed
    2 / 34 (5.88%)
    4 / 87 (4.60%)
         occurrences all number
    2
    4
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    3 / 34 (8.82%)
    6 / 87 (6.90%)
         occurrences all number
    3
    11
    Decreased appetite
         subjects affected / exposed
    5 / 34 (14.71%)
    18 / 87 (20.69%)
         occurrences all number
    5
    19
    Hyperglycaemia
         subjects affected / exposed
    3 / 34 (8.82%)
    6 / 87 (6.90%)
         occurrences all number
    9
    21
    Hypokalaemia
         subjects affected / exposed
    3 / 34 (8.82%)
    7 / 87 (8.05%)
         occurrences all number
    9
    14
    Hypomagnesaemia
         subjects affected / exposed
    1 / 34 (2.94%)
    7 / 87 (8.05%)
         occurrences all number
    1
    10
    Hypoalbuminaemia
         subjects affected / exposed
    3 / 34 (8.82%)
    3 / 87 (3.45%)
         occurrences all number
    7
    4
    Dehydration
         subjects affected / exposed
    2 / 34 (5.88%)
    4 / 87 (4.60%)
         occurrences all number
    2
    4
    Hyponatraemia
         subjects affected / exposed
    3 / 34 (8.82%)
    2 / 87 (2.30%)
         occurrences all number
    7
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jul 2016
    Safety management algorithms updated

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 09 18:11:45 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA