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    Clinical Trial Results:
    An Open-Label Treatment Use Protocol for Daratumumab in Subjects with Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and an Immunomodulatory Agent) or are Double Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent

    Summary
    EudraCT number
    2015-002993-19
    Trial protocol
    GB   ES   IT  
    Global end of trial date
    02 Aug 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Aug 2019
    First version publication date
    22 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    54767414MMY3010
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02477891
    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
    15 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to provide early access to daratumumab treatment and collect additional safety data while the medication was not yet commercially available for subjects with multiple myeloma who had received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an Immunomodulatory agent (IMiD) or whose disease was double refractory to both a PI and an IMiD.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety was evaluated based on the following variables: Adverse events, Clinical laboratory tests (hematology, serum chemistry, and urinalysis), Vital sign measurements, Physical examinations, and Eastern Cooperative Oncology Group (ECOG) performance status.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Jun 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
    Spain: 73
    Country: Number of subjects enrolled
    United Kingdom: 98
    Country: Number of subjects enrolled
    United States: 348
    Country: Number of subjects enrolled
    Brazil: 49
    Country: Number of subjects enrolled
    Italy: 72
    Country: Number of subjects enrolled
    Japan: 2
    Country: Number of subjects enrolled
    Russian Federation: 50
    Worldwide total number of subjects
    692
    EEA total number of subjects
    243
    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)
    338
    From 65 to 84 years
    348
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 692 subjects were analyzed in this study.

    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
    DARATUMUMAB 16 mg/kg
    Arm description
    Subjects received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion on Days 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Days 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing) until disease progression, unacceptable toxicity, subject was no longer receiving clinical benefit, or the end of study. Each cycle was of 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received daratumumab 16 mg/kg on Days 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Days 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing).

    Number of subjects in period 1
    DARATUMUMAB 16 mg/kg
    Started
    692
    Completed
    18
    Not completed
    674
         Progressive disease
    333
         Adverse event, serious non-fatal
    1
         Lack of efficacy
    2
         Consent withdrawn by subject
    15
         Disease relapse
    7
         Adverse event, serious fatal
    38
         Physician decision
    7
         Adverse event
    27
         Adverse event - other
    1
         Non-compliance with study drug
    1
         Market authorization/reimbursement
    231
         Unspecified
    7
         Lost to follow-up
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DARATUMUMAB 16 mg/kg
    Reporting group description
    Subjects received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion on Days 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Days 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing) until disease progression, unacceptable toxicity, subject was no longer receiving clinical benefit, or the end of study. Each cycle was of 28 days.

    Reporting group values
    DARATUMUMAB 16 mg/kg Total
    Number of subjects
    692 692
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    338 338
        From 65 to 84 years
    348 348
        85 years and over
    6 6
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    64.2 ± 9.82 -
    Title for Gender
    Units: subjects
        Female
    306 306
        Male
    386 386

    End points

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    End points reporting groups
    Reporting group title
    DARATUMUMAB 16 mg/kg
    Reporting group description
    Subjects received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion on Days 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Days 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing) until disease progression, unacceptable toxicity, subject was no longer receiving clinical benefit, or the end of study. Each cycle was of 28 days.

    Primary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

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    End point title
    Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non investigational) product and does not necessarily have a causal relationship with treatment. TEAEs are defined as any AE with onset date and time on or after that of first dose through 30 days after last study drug administration, or any AE that is considered related to (very likely, probably, or possibly related) study medication regardless of start date of event. Serious TEAEs was an AE that resulted in any of the following outcomes: death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, suspected transmission of any infectious agent via a medicinal product. All treated analysis population includes subjects who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 3.1 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
    DARATUMUMAB 16 mg/kg
    Number of subjects analysed
    692
    Units: Subjects
        TEAEs
    561
        Serious TEAEs
    283
    No statistical analyses for this end point

    Primary: Number of Subjects With Grade 3 or 4 TEAEs

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    End point title
    Number of Subjects With Grade 3 or 4 TEAEs [2]
    End point description
    TEAEs are defined as any AE with onset date and time on or after that of the first dose through 30 days after the last study drug administration, or any AE that is considered related to (very likely, probably, or possibly related) study medication regardless of the start date of the event. Subjects with grade 3 or 4 TEAEs were assessed.
    End point type
    Primary
    End point timeframe
    Up to 3.1 years
    Notes
    [2] - 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
    DARATUMUMAB 16 mg/kg
    Number of subjects analysed
    692
    Units: Subjects
    372
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 3.1 Years
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    DARATUMUMAB
    Reporting group description
    Subjects received daratumumab 16 milligram per kilogram (mg/kg) as intravenous infusion on Days 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Days 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing) until disease progression, unacceptable toxicity, subject was no longer receiving clinical benefit, or the end of study. Each cycle was of 28 days.

    Serious adverse events
    DARATUMUMAB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    283 / 692 (40.90%)
         number of deaths (all causes)
    60
         number of deaths resulting from adverse events
    Vascular disorders
    Arterial Stenosis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    6 / 692 (0.87%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    1 / 1
    Hypertension
         subjects affected / exposed
    7 / 692 (1.01%)
         occurrences causally related to treatment / all
    5 / 7
         deaths causally related to treatment / all
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    4 / 692 (0.58%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    1 / 1
    Shock
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasma Cell Leukaemia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Plasma Cell Myeloma
         subjects affected / exposed
    4 / 692 (0.58%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    Plasmacytoma
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Squamous Cell Carcinoma of Skin
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Anaphylactic Reaction
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 692 (0.58%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Chest Pain
         subjects affected / exposed
    5 / 692 (0.72%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 2
    Chest Discomfort
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Chills
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Device Dislocation
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Condition Aggravated
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Fatigue
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Disease Progression
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General Physical Health Deterioration
         subjects affected / exposed
    11 / 692 (1.59%)
         occurrences causally related to treatment / all
    0 / 11
         deaths causally related to treatment / all
    0 / 10
    Infusion Site Reaction
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple Organ Dysfunction Syndrome
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Non-Cardiac Chest Pain
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    5 / 692 (0.72%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    Pyrexia
         subjects affected / exposed
    23 / 692 (3.32%)
         occurrences causally related to treatment / all
    9 / 25
         deaths causally related to treatment / all
    1 / 2
    Psychiatric disorders
    Confusional State
         subjects affected / exposed
    7 / 692 (1.01%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    Mental Status Changes
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Substance-Induced Psychotic Disorder
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Pelvic Pain
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Femur Fracture
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fracture
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hip Fracture
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pelvic Fracture
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infusion Related Reaction
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rib Fracture
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal Cord Injury Thoracic
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Spinal Fracture
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Sternal Fracture
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Thoracic Vertebral Fracture
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Blood Creatinine Increased
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ejection Fraction Decreased
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General Physical Condition Abnormal
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oxygen Saturation Decreased
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    Cardiac Failure Acute
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac Failure Congestive
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiopulmonary Failure
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiovascular Insufficiency
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Left Ventricular Dysfunction
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cough
         subjects affected / exposed
    5 / 692 (0.72%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    13 / 692 (1.88%)
         occurrences causally related to treatment / all
    6 / 14
         deaths causally related to treatment / all
    0 / 0
    Lung Disorder
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hypoxia
         subjects affected / exposed
    4 / 692 (0.58%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nasal Congestion
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Obstructive Airways Disorder
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    5 / 692 (0.72%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    Pleural Fibrosis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleuritic Pain
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Pulmonary Oedema
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Respiratory Failure
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Rhinorrhoea
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sneezing
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Throat Irritation
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Wheezing
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Throat Tightness
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    12 / 692 (1.73%)
         occurrences causally related to treatment / all
    3 / 12
         deaths causally related to treatment / all
    0 / 1
    Bone Marrow Failure
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    Febrile Neutropenia
         subjects affected / exposed
    13 / 692 (1.88%)
         occurrences causally related to treatment / all
    3 / 13
         deaths causally related to treatment / all
    1 / 2
    Hyperviscosity Syndrome
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    4 / 692 (0.58%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Neutropenia
         subjects affected / exposed
    4 / 692 (0.58%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    Thrombocytopenia
         subjects affected / exposed
    18 / 692 (2.60%)
         occurrences causally related to treatment / all
    7 / 29
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Central Nervous System Lesion
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cognitive Disorder
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Loss of Consciousness
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Posterior Reversible Encephalopathy Syndrome
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    Spinal Cord Compression
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Status Epilepticus
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Speech Disorder
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Subarachnoid Haemorrhage
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vith Nerve Paralysis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Eye Pruritus
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal Detachment
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Ear Haemorrhage
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    4 / 692 (0.58%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    6 / 692 (0.87%)
         occurrences causally related to treatment / all
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal Disorder
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal Perforation
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Oesophageal Ulcer
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral Pruritus
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    14 / 692 (2.02%)
         occurrences causally related to treatment / all
    2 / 14
         deaths causally related to treatment / all
    0 / 3
    Chronic Kidney Disease
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cystitis Noninfective
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal Disorder
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal Impairment
         subjects affected / exposed
    6 / 692 (0.87%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    Renal Failure
         subjects affected / exposed
    7 / 692 (1.01%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    0 / 3
    Hepatobiliary disorders
    Hepatic Failure
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    12 / 692 (1.73%)
         occurrences causally related to treatment / all
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    Arthralgia
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bone Pain
         subjects affected / exposed
    6 / 692 (0.87%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Fracture Pain
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Muscle Spasms
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Osteolysis
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pain in Extremity
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal Pain
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Diabetic Ketoacidosis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Failure to Thrive
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hypercalcaemia
         subjects affected / exposed
    24 / 692 (3.47%)
         occurrences causally related to treatment / all
    2 / 31
         deaths causally related to treatment / all
    0 / 2
    Malnutrition
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Adenovirus Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacteraemia
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bacterial Sepsis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Campylobacter Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium Difficile Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia Sepsis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia Bacteraemia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    5 / 692 (0.72%)
         occurrences causally related to treatment / all
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    Herpes Zoster Disseminated
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    11 / 692 (1.59%)
         occurrences causally related to treatment / all
    5 / 12
         deaths causally related to treatment / all
    0 / 1
    Lung Infection
         subjects affected / exposed
    6 / 692 (0.87%)
         occurrences causally related to treatment / all
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    Neutropenic Sepsis
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Parainfluenzae Virus Infection
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumococcal Bacteraemia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumococcal Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    31 / 692 (4.48%)
         occurrences causally related to treatment / all
    12 / 34
         deaths causally related to treatment / all
    0 / 1
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pneumonia Haemophilus
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia Streptococcal
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Post Procedural Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Sepsis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    7 / 692 (1.01%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    Rhinitis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rhinovirus Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    10 / 692 (1.45%)
         occurrences causally related to treatment / all
    4 / 10
         deaths causally related to treatment / all
    1 / 2
    Septic Shock
         subjects affected / exposed
    5 / 692 (0.72%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 3
    Sinusitis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Soft Tissue Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal Bacteraemia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tooth Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    8 / 692 (1.16%)
         occurrences causally related to treatment / all
    1 / 8
         deaths causally related to treatment / all
    0 / 1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    6 / 692 (0.87%)
         occurrences causally related to treatment / all
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    Viral Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    DARATUMUMAB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    373 / 692 (53.90%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    77 / 692 (11.13%)
         occurrences all number
    80
    Dyspnoea
         subjects affected / exposed
    68 / 692 (9.83%)
         occurrences all number
    71
    Nasal Congestion
         subjects affected / exposed
    47 / 692 (6.79%)
         occurrences all number
    48
    Throat Irritation
         subjects affected / exposed
    35 / 692 (5.06%)
         occurrences all number
    36
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    89 / 692 (12.86%)
         occurrences all number
    145
    Lymphopenia
         subjects affected / exposed
    47 / 692 (6.79%)
         occurrences all number
    70
    Neutropenia
         subjects affected / exposed
    67 / 692 (9.68%)
         occurrences all number
    117
    Thrombocytopenia
         subjects affected / exposed
    106 / 692 (15.32%)
         occurrences all number
    227
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    66 / 692 (9.54%)
         occurrences all number
    73
    Pyrexia
         subjects affected / exposed
    49 / 692 (7.08%)
         occurrences all number
    51
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    44 / 692 (6.36%)
         occurrences all number
    47

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Mar 2014
    The first amendment included following changes- addition of an exclusion criterion for subjects who had prior exposure to any anti-CD38 monoclonal antibody.
    15 Jul 2015
    The second amendment included following changes- addition of Exit Interviews, clarification of the administration of post-infusion treatment, and reduction in sample size.
    12 Oct 2015
    The third amendment included following changes- increase in the sample size to accommodate sites globally, adoption of the “End of Study definition” for enrollment and marketing authorization, modification of the term “Exit Interview” to “Subject Interview” and the addition of the PRO, European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Multiple Myeloma Module 20 (MY20) at selected sites.

    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.
    Number of subjects enrolled refers to the number of patients treated in this study. The "number of subjects completed / not-completed breakdown by reasons table" refers to subjects completed / discontinued the study.
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