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    Clinical Trial Results:
    An Open Label, Phase 2 Study to Evaluate Efficacy and Safety of Daratumumab in Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

    Summary
    EudraCT number
    		 2014-005299-26
    Trial protocol
    		 BE   NL  
    Global end of trial date
    01 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jun 2018
    First version publication date
    13 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    54767414LYM2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02413489
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International N.V, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International N.V, ClinicalTrialsEU@its.jnj.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
    01 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives were to assess overall response rate (ORR), including complete response (CR) and partial response (PR), of daratumumab in subjects with non-Hodgkin’s lymphoma (NHL) and to evaluate association between ORR and CD38 expression level in order to determine a threshold for CD38 expression level in each NHL subtype, above which daratumumab activity is enhanced.
    Protection of trial subjects
    Safety evaluations included adverse event monitoring, physical examinations, electrocardiogram (ECG) monitoring, clinical laboratory parameters (hematology, urinalysis and chemistry), vital sign measurements, and Eastern Cooperative Oncology Group (ECOG) performance status.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Turkey: 5
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    36
    EEA total number of subjects
    15
    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)
    18
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In total 36 subjects were treated (15 subjects in the diffuse large B-cell lymphoma {DLBCL} cohort, 16 subjects in the follicular lymphoma {FL} cohort, and 5 subjects in the mantle cell lymphoma {MCL} cohort).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Diffuse Large B-cell Lymphoma (DLBCL)
    Arm description
    		 Subjects received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received daratumumab 16 mg/kg as intravenous infusion.

    Arm title
    		 Follicular Lymphoma (FL)
    Arm description
    		 Subjects received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received daratumumab 16 mg/kg as intravenous infusion.

    Arm title
    		 Mantle Cell Lymphoma (MCL)
    Arm description
    		 Subjects received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received daratumumab 16 mg/kg as intravenous infusion.

    Number of subjects in period 1
    		Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
    Started
    15
    16
    5
    Completed
    0
    0
    0
    Not completed
    15
    16
    5
         Consent withdrawn by subject
    2
    -
    -
         Death
    11
    3
    4
         Study terminated by sponsor
    2
    13
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Diffuse Large B-cell Lymphoma (DLBCL)
    Reporting group description
    		 Subjects received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

    Reporting group title
    Follicular Lymphoma (FL)
    Reporting group description
    		 Subjects received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

    Reporting group title
    Mantle Cell Lymphoma (MCL)
    Reporting group description
    		 Subjects received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

    Reporting group values
    		 Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL) Total
    Number of subjects
    		 15 16 5 36
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 5 9 4 18
        From 65 to 84 years
    		 10 7 1 18
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.7 ( 11.88 ) 62.3 ( 9.77 ) 59.8 ( 6.69 ) -
    Title for Gender
    Units: subjects
        Female
    		 6 5 0 11
        Male
    		 9 11 5 25
    CD38 expression value
    The expression levels of CD38 were used to do diagnosis of MCL, DLBCL, or FL and measurable disease.
    Units: Percentage of CD38 expression
        arithmetic mean (standard deviation)
    		 76.3 ( 18.07 ) 70.3 ( 16.78 ) 64 ( 8.22 ) -

    End points

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    End points reporting groups
    Reporting group title
    Diffuse Large B-cell Lymphoma (DLBCL)
    Reporting group description
    		 Subjects received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

    Reporting group title
    Follicular Lymphoma (FL)
    Reporting group description
    		 Subjects received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

    Reporting group title
    Mantle Cell Lymphoma (MCL)
    Reporting group description
    		 Subjects received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

    Primary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR) [1]
    End point description
    ORR was defined as the percentage of subjects who achieved complete response (CR) or partial response (PR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), or Magnetic resonance imaging (MRI) scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a > 50 % decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites. The analysis population was all subjects that were treated with daratumumab. Here “99999” indicates data was not estimable as no subjects had response.
    End point type
    Primary
    End point timeframe
    After the first dose until disease progression, withdrawal of consent from study participation, or the end of study (approximately 1.9 years)
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
    Number of subjects analysed
    15
    16
    5
    Units: Percentage of subjects
        number (confidence interval 95%)
    6.7 (0.2 to 31.9)
    12.5 (1.6 to 38.3)
    0 (0 to 99999)
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of response was the duration from the date of the initial documentation of a response to the date of first documented evidence of progressive disease (PD). PD is defined as any new lesion >1.5 centimeter (cm) in any axis or >=50% increase in previously involved sites. The analysis population was all subjects that were treated with daratumumab and who achieved overall response There was insufficient data to perform Kaplan Meier analysis, therefore individual data for each evaluable subject was reported.
    End point type
    Secondary
    End point timeframe
    Approximately 1.9 years
    End point values
    		 Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
    Number of subjects analysed
    1
    2
    0 [2]
    Units: Months
    number (not applicable)
        Subject 1
    1.6
    0.7
        Subject 2
    0
    7.4
    Notes
    [2] - None of subjects achieved response for this particular arm.
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS was defined as the duration from the date of the first daratumumab dose to the date of Progression or death, whichever comes first. The analysis population was all subjects that were treated with daratumumab.
    End point type
    Secondary
    End point timeframe
    Approximately 1.9 years
    End point values
    		 Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
    Number of subjects analysed
    15
    16
    5
    Units: Months
        number (confidence interval 95%)
    1.2 (0.6 to 1.7)
    3.3 (1.9 to 3.8)
    1.3 (0.5 to 1.9)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival was defined as the duration from the date of the first daratumumab dose to the date of death. The analysis population was all subjects that were treated with daratumumab. Here "99999" upper limit of CI was not estimable due to less number of subjects with events and "99999" for MCL group indicates that Upper limit of CI could not be estimated due to less number of subjects analyzed.
    End point type
    Secondary
    End point timeframe
    Approximately 1.9 years
    End point values
    		 Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
    Number of subjects analysed
    15
    16
    5
    Units: Months
        number (confidence interval 95%)
    4.9 (2.1 to 9.0)
    17.2 (15.0 to 99999)
    4.8 (1.7 to 99999)
    No statistical analyses for this end point

    Secondary: Time to Response

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    End point title
    		 Time to Response
    End point description
    Time to response was defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR) is first documented. The analysis population was all subjects that were treated with daratumumab and who achieved overall response There was insufficient data to perform Kaplan Meier analysis, therefore individual data for each evaluable subject was reported.
    End point type
    Secondary
    End point timeframe
    Approximately 1.9 years
    End point values
    		 Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
    Number of subjects analysed
    1
    2
    0 [3]
    Units: Months
    number (not applicable)
        Subject 1
    1.9
    2.3
        Subject 2
    0
    1.9
    Notes
    [3] - None of subjects achieved response for this particular arm.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 1.9 years
    Adverse event reporting additional description
    Analysis set included all subjects who received at least 1 dose of study treatment, and contributed any safety data after the start of study treatment.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Diffuse Large B-cell Lymphoma (DLBCL)
    Reporting group description
    		 Subjects received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

    Reporting group title
    Follicular Lymphoma (FL)
    Reporting group description
    		 Subjects received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

    Reporting group title
    Mantle Cell Lymphoma (MCL)
    Reporting group description
    		 Subjects received daratumumab 16 mg/kg as intravenous infusion once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.

    Serious adverse events
    		 Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 15 (40.00%)
    6 / 16 (37.50%)
    3 / 5 (60.00%)
         number of deaths (all causes)
    11
    3
    4
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Spinal Fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile Neutropenia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    2 / 5 (40.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain Lower
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Kidney Disease
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumonia Cytomegaloviral
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    16 / 16 (100.00%)
    5 / 5 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2
    1
    Hot Flush
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Hypertension
         subjects affected / exposed
    2 / 15 (13.33%)
    3 / 16 (18.75%)
    0 / 5 (0.00%)
         occurrences all number
    2
    3
    0
    Hypotension
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Catheter Site Erythema
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Catheter Site Inflammation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Chest Discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Chills
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    1
    Fatigue
         subjects affected / exposed
    4 / 15 (26.67%)
    3 / 16 (18.75%)
    1 / 5 (20.00%)
         occurrences all number
    4
    4
    1
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza Like Illness
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Malaise
         subjects affected / exposed
    3 / 15 (20.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    4
    1
    0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Oedema Peripheral
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 16 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    1
    2
    3
    Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    2 / 15 (13.33%)
    4 / 16 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    6
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 15 (46.67%)
    6 / 16 (37.50%)
    4 / 5 (80.00%)
         occurrences all number
    7
    9
    5
    Dysphonia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 16 (12.50%)
    2 / 5 (40.00%)
         occurrences all number
    1
    2
    3
    Hiccups
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoxia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Laryngeal Oedema
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal Congestion
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 16 (18.75%)
    1 / 5 (20.00%)
         occurrences all number
    0
    4
    1
    Oropharyngeal Discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngeal Oedema
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Pleural Effusion
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Productive Cough
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    5
    0
    Rales
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory Failure
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Sinus Congestion
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Sneezing
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Throat Irritation
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    3
    Upper-Airway Cough Syndrome
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    Delirium
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Depressed Mood
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Insomnia
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 16 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    3
    3
    1
    Product issues
    Thrombosis in Device
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    1
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    C-Reactive Protein Increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Cytomegalovirus Test Positive
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Oxygen Saturation Decreased
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Prostatic Specific Antigen Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Weight Decreased
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    3
    2
    0
    Weight Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Hip Fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Skin Abrasion
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Sinus Bradycardia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
         occurrences all number
    1
    2
    1
    Dysarthria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 15 (0.00%)
    5 / 16 (31.25%)
    1 / 5 (20.00%)
         occurrences all number
    0
    6
    1
    Nerve Compression
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Neuralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Post Herpetic Neuralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Sensory Disturbance
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    5 / 16 (31.25%)
    1 / 5 (20.00%)
         occurrences all number
    1
    8
    1
    Leukopenia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Lymph Node Pain
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    2
    4
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphocytosis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphopenia
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    8
    0
    Neutropenia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
         occurrences all number
    1
    4
    2
    Thrombocytopenia
         subjects affected / exposed
    3 / 15 (20.00%)
    3 / 16 (18.75%)
    1 / 5 (20.00%)
         occurrences all number
    4
    7
    4
    Ear and labyrinth disorders
    Ear Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema of Eyelid
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid Oedema
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Ocular Hyperaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Visual Acuity Reduced
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal Pain
         subjects affected / exposed
    2 / 15 (13.33%)
    5 / 16 (31.25%)
    1 / 5 (20.00%)
         occurrences all number
    2
    5
    1
    Abdominal Pain Lower
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Anal Incontinence
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 16 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    2
    2
    1
    Dental Caries
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    2
    0
    Dry Mouth
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    5 / 15 (33.33%)
    1 / 16 (6.25%)
    2 / 5 (40.00%)
         occurrences all number
    7
    1
    3
    Paraesthesia Oral
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Swollen Tongue
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    4 / 15 (26.67%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    5
    0
    2
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Blister
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    Erythema
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    2
    Night Sweats
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    2
    0
    Pain of Skin
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    3
    3
    0
    Pruritus
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    0
    1
    Rash
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Skin Burning Sensation
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 15 (6.67%)
    3 / 16 (18.75%)
    0 / 5 (0.00%)
         occurrences all number
    2
    3
    0
    Renal and urinary disorders
    Chronic Kidney Disease
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary Tract Obstruction
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Urine Flow Decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    3
    0
    Back Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    4 / 16 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    5
    1
    Flank Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Mobility Decreased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle Spasms
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    2 / 5 (40.00%)
         occurrences all number
    0
    3
    2
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal Pain
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    2
    0
    Pain in Extremity
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 16 (18.75%)
    1 / 5 (20.00%)
         occurrences all number
    0
    4
    1
    Pain in Jaw
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Peripheral Arthritis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Fungal Skin Infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Genital Herpes
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Groin Infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes Zoster
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    1
    Pneumonia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 15 (6.67%)
    3 / 16 (18.75%)
    0 / 5 (0.00%)
         occurrences all number
    1
    3
    0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    Vitamin B12 Deficiency
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jan 2015
    The main reason of this amendment was to Optimization of candidate screening potential, elaboration on Indirect Antiglobulin (Coombs) Testing (IAT) during the Screening Phase due to the risk of daratumumab interference with IAT, as well as updates throughout the protocol to align with the other daratumumab protocols, and some minor editorial changes.

    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.
    The study was terminated due to 2 non-Hodgkin’s lymphoma (NHL) subtypes ([DLBCL] and FL cohorts) meeting the futility criteria defined in the protocol, and the cell lymphoma (MCL) cohort not having adequate recruitment.
    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.

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