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    Clinical Trial Results:
    Feasibility and Efficacy of dose adjusted Melphalan – Prednisone – Bortezomib (MPV) in elderly patients ≥ 75 years of age with newly diagnosed Multiple Myeloma; a nonrandomised phase II study

    Summary
    EudraCT number
    2013-000320-33
    Trial protocol
    NL  
    Global end of trial date
    29 Jun 2022

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

    Trial information

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    Trial identification
    Sponsor protocol code
    HOVON_123_MM
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    HOVON
    Sponsor organisation address
    De Boelelaan 1117, Amsterdam, Netherlands,
    Public contact
    HOVON Data Center, HOVON, +31 (0)107041560, hdc@erasmusmc.nl
    Scientific contact
    HOVON Data Center, HOVON, +31 (0)107041560, hdc@erasmusmc.nl
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the feasibility, defined as discontinuation rate, of a dose-adapted MPV scheme in MM patients ≥ 75 years of age
    Protection of trial subjects
    Monitoring and Insurance
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Jan 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 240
    Worldwide total number of subjects
    240
    EEA total number of subjects
    240
    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)
    0
    From 65 to 84 years
    212
    85 years and over
    28

    Subject disposition

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

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

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

    Arms
    Arm title
    Experimental
    Arm description
    Experimental
    Arm type
    Experimental

    Investigational medicinal product name
    Bortezomib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IMP: Bortezomib Duration of each cycle is 35 days (every 5 weeks). Total number of cycles is 9. dose/day: 1.3 mg/m2 Route of administration: s.c. days of administration: 1, 8, 15, 22

    Investigational medicinal product name
    Melphalan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    day 1-4 for a maximum of 9 cycles 6 mg/m2 milligram(s)/square meter/day

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    day 1 to 4 for a maximum of 9 cycles 30 mg/m2 milligram(s)/square meter/ day

    Number of subjects in period 1
    Experimental
    Started
    240
    Completed
    130
    Not completed
    110
         Adverse reactions
    39
         At patient's request
    24
         other
    15
         Lack of efficacy
    32

    Baseline characteristics

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

    Reporting group values
    Overall period Total
    Number of subjects
    240 240
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    212 212
        85 years and over
    28 28
    Age continuous
    Units: years
        median (full range (min-max))
    79 (75 to 91) -
    Gender categorical
    Units: Subjects
        Female
    116 116
        Male
    124 124

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    Experimental

    Primary: primary endpoint

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    End point title
    primary endpoint [1]
    End point description
    End point type
    Primary
    End point timeframe
    see publication
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See attached chart/documents for results
    End point values
    Experimental
    Number of subjects analysed
    201
    Units: whole
    201
    Attachments
    List of reported non-SAE's
    Statistical data section from publication
    List of reported SAE's
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs will be reported from the first study-related procedure until 30 days following the last dose of any drug from the protocol treatment schedule or until the start of subsequent systemic therapy for the disease under investigation, if earlier.
    Adverse event reporting additional description
    Adverse events occurring after 30 days should also be reported if considered at least possibly related to the investigational medicinal product by the investigator.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Experimental
    Reporting group description
    -

    Serious adverse events
    Experimental
    Total subjects affected by serious adverse events
         subjects affected / exposed
    132 / 234 (56.41%)
         number of deaths (all causes)
    179
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    AML
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Basal cell carcinoma
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Multiple myeloma progression
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Oesophagus carcinoma
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal carcinoma
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urotheelcelcarcinoma
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Cerebral ischemia
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Collapse(vasovagal episode)
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ruptured abdominal aneurysm
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vein thrombosis
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Venous thrombosis right leg
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Hip surgery
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgery
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Admission pain
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atypical thoracal/precordial pain
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Backpain
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Exacerbation pain
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    9 / 234 (3.85%)
         occurrences causally related to treatment / all
    8 / 14
         deaths causally related to treatment / all
    0 / 0
    Fever, unknown cause
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Malaise
         subjects affected / exposed
    4 / 234 (1.71%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Non-neutropenic fever
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Overall weakness
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Recurrent bleeding along catheter vena jugelaris
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sudden death NOS
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COPD exacerbatie
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnea
         subjects affected / exposed
    6 / 234 (2.56%)
         occurrences causally related to treatment / all
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Exp. COPD
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonitis
         subjects affected / exposed
    4 / 234 (1.71%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Relapse pleural effusion
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Confusion
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Delirium
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Increased CRP
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Weight loss
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fracture
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Cardiac failure
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congestive heart failure
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Decompensatio cordis
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Decompensation cardiac
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Flutter
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Heart failure
         subjects affected / exposed
    4 / 234 (1.71%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Mitralis insufficiency
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NSTEMI
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Right ventricular dysfunction
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    STEMI
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Unstable angina pectoris
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Admission because of dizziness
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    CVA
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Ischialgie
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neurological paralysis
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Stroke
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischemic attack
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    5 / 234 (2.14%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    Anemia / thrombocytopenia
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Neutropenic fever
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    Thrombopenia
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    (Symtomatic) Anemia
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    4 / 234 (1.71%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Diarrhea
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Emesis
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders other
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea and vomiting
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Rectal bleeding
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting and diarrhea
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Ulcer left foot
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Kidney failure
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    Pain right kidney area intermittent
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Progressive renal insufficiency
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal insufficiency
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary retention
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Backache
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bone pain
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Myopathy
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain back
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain due to MM
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Painfull hip
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Refered pain right leg
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Airway infection
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Catheter related infection
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis of her right leg
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastro
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection leg
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection pulmonary
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection urinarytract
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection without focus
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Phlebitis infective
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    26 / 234 (11.11%)
         occurrences causally related to treatment / all
    25 / 30
         deaths causally related to treatment / all
    1 / 2
    Pneumosepsis
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory infection
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    5 / 234 (2.14%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    5 / 234 (2.14%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Yeast infection
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    4 / 234 (1.71%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    Hyper calcemia
         subjects affected / exposed
    4 / 234 (1.71%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hyperglyceamia
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperkalemia
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hyponatremia
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Experimental
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    215 / 234 (91.88%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    4 / 234 (1.71%)
         occurrences all number
    4
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    17 / 234 (7.26%)
         occurrences all number
    18
    Surgical and medical procedures
    Surgical and medical procedures
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences all number
    2
    General disorders and administration site conditions
    General disorders and adminstration site conditions
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    90 / 234 (38.46%)
         occurrences all number
    127
    Immune system disorders
    Immune system disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    3 / 234 (1.28%)
         occurrences all number
    3
    Reproductive system and breast disorders
    Reproductive system and breast disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    1 / 234 (0.43%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    23 / 234 (9.83%)
         occurrences all number
    32
    Psychiatric disorders
    Psychiatric disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    14 / 234 (5.98%)
         occurrences all number
    18
    Investigations
    Investigations
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    90 / 234 (38.46%)
         occurrences all number
    294
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    5 / 234 (2.14%)
         occurrences all number
    6
    Cardiac disorders
    Cardiac disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    18 / 234 (7.69%)
         occurrences all number
    19
    Nervous system disorders
    Nervous system disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    127 / 234 (54.27%)
         occurrences all number
    211
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    52 / 234 (22.22%)
         occurrences all number
    92
    Ear and labyrinth disorders
    Ear and labyrinth disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 234 (0.85%)
         occurrences all number
    2
    Eye disorders
    Eye disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    15 / 234 (6.41%)
         occurrences all number
    18
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    86 / 234 (36.75%)
         occurrences all number
    143
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    21 / 234 (8.97%)
         occurrences all number
    23
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    21 / 234 (8.97%)
         occurrences all number
    25
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    45 / 234 (19.23%)
         occurrences all number
    68
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    60 / 234 (25.64%)
         occurrences all number
    76
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    46 / 234 (19.66%)
         occurrences all number
    70

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2015
    Expansion of study by 100 patients
    26 Feb 2016
    Update to the protocol due to an error in Appendix A

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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

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