Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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


    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST™ Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery

    Summary
    EudraCT number
    2013-002535-24
    Trial protocol
    GB  
    Global end of trial date
    22 Sep 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Mar 2016
    First version publication date
    26 Mar 2016
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    BIOS-13-005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ethicon, a Johnson & Johnson company
    Sponsor organisation address
    Route 22 West, Somerville, United States, NJ 08876-0151
    Public contact
    Clinical Development, Johnson & Johnson Medical Ltd., +44 1506594675, vjevans@its.jnj.com
    Scientific contact
    Clinical Development, Johnson & Johnson Medical Ltd., +44 1506594675, vjevans@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 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and hemostatic effectiveness of EVARREST Fibrin Sealant Patch versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
    Protection of trial subjects
    A DMC was established. The DMC was to be convened if a stopping rule for safety was met, however no such stopping rule requiring DMC review was met for this trial. In addition a Clinical Adjudication Committee was appointed to adjudicate adverse events or serious adverse events that were potentially related to target bleeding site bleeding or thrombotic events.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Oct 2013
    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
    United Kingdom: 30
    Country: Number of subjects enrolled
    United States: 36
    Country: Number of subjects enrolled
    Australia: 23
    Country: Number of subjects enrolled
    New Zealand: 13
    Worldwide total number of subjects
    102
    EEA total number of subjects
    30
    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)
    54
    From 65 to 84 years
    47
    85 years and over
    1

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Potentially eligible patients were reviewed and enrolled following the consent process. Screening involved a full history, physical examination, determination of full blood count, LFT's, coagulation studies and if appropriate, pregnancy test and occurred within 21 days of the surgical procedure.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    EVARREST
    Arm description
    EVARREST
    Arm type
    Experimental

    Investigational medicinal product name
    EVARREST
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sealant matrix
    Routes of administration
    Topical use
    Dosage and administration details
    Up to 4 units (10.2 x 10.2cm / 4x4 in) of EVARREST were permitted to be left in place at treatment sites per subjects randomized to treatment with EVARREST. After placement of EVARREST, firm manual compression sufficient to stem all bleeding was applied continuously and maintained until 4 minutes post randomization.

    Arm title
    Standard of care
    Arm description
    Standard of care
    Arm type
    Standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    EVARREST Standard of care
    Started
    50
    52
    Completed
    48
    49
    Not completed
    2
    3
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    EVARREST
    Reporting group description
    EVARREST

    Reporting group title
    Standard of care
    Reporting group description
    Standard of care

    Reporting group values
    EVARREST Standard of care Total
    Number of subjects
    50 52 102
    Age categorical
    Units: Subjects
        Adults 18-<50 years
    11 5 16
        Adults 50-<65 years
    15 23 38
        Adults 65-<75 years
    17 15 32
        Adults >=75
    7 9 16
    Gender categorical
    Units: Subjects
        Female
    20 20 40
        Male
    30 32 62

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    EVARREST
    Reporting group description
    EVARREST

    Reporting group title
    Standard of care
    Reporting group description
    Standard of care

    Subject analysis set title
    Safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety analysis set

    Subject analysis set title
    Intent to treat (ITT)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Intent to treat

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Per protocol

    Primary: Hemostasis at 4 mins and maintenance to wound closure

    Close Top of page
    End point title
    Hemostasis at 4 mins and maintenance to wound closure
    End point description
    End point type
    Primary
    End point timeframe
    4-minutes after randomization
    End point values
    EVARREST Standard of care
    Number of subjects analysed
    50
    52
    Units: Percentage of successes
    96
    46
    Statistical analysis title
    Primary efficacy endpoint
    Comparison groups
    EVARREST v Standard of care
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Chi-squared
    Confidence interval

    Secondary: Hemostasis at 10 mins and maintenance to wound closure

    Close Top of page
    End point title
    Hemostasis at 10 mins and maintenance to wound closure
    End point description
    End point type
    Secondary
    End point timeframe
    Hemostatic success at 10 minutes post randomization
    End point values
    EVARREST Standard of care
    Number of subjects analysed
    50
    52
    Units: Percentage of successes
    98
    81
    Statistical analysis title
    Secondary endpoint analysis
    Comparison groups
    EVARREST v Standard of care
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.1243 [2]
    Method
    Logistic model
    Confidence interval
    Notes
    [1] - Secondary endpoint analysis - therefore no formal hypothesis testing
    [2] - In the ITT analysis the p-value was 0.1243 and did not show statistical significance, however in the PP analysis a statistical difference in favour of EVARREST compared to SOC was achieved (P=0.0126)

    Secondary: Absolute time to hemostasis

    Close Top of page
    End point title
    Absolute time to hemostasis
    End point description
    End point type
    Secondary
    End point timeframe
    Absolute time to hemostasis (mins)
    End point values
    EVARREST Standard of care
    Number of subjects analysed
    50
    51 [3]
    Units: Minutes
        median (full range (min-max))
    4 (4 to 15.9)
    4.7 (1.7 to 33)
    Notes
    [3] - One missing result
    Statistical analysis title
    Secondary endpoint analysis
    Comparison groups
    EVARREST v Standard of care
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    P-value
    < 0.0001
    Method
    Wilcoxon rank-sum
    Confidence interval
    Notes
    [4] - Secondary endpoint analysis - no formal hypothesis testing

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    AE's were collected from the point of randomization during the surgical procedure, throughout the hospital admission, and until completion of the 60-day follow-up visit.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    EVARREST
    Reporting group description
    -

    Reporting group title
    Standard of care
    Reporting group description
    -

    Serious adverse events
    EVARREST Standard of care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 50 (24.00%)
    16 / 52 (30.77%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Chemical peritonitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound decomposition
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Orthostatic hypertension
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised intraabdominal fluid collection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
    Additional description: This event term of renal failure includes those coded to renal failure, renal failure acute and renal failure chronic.
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdiaphragmatic abscess
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    EVARREST Standard of care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 50 (90.00%)
    50 / 52 (96.15%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 50 (12.00%)
    5 / 52 (9.62%)
         occurrences all number
    6
    5
    Hypotension
         subjects affected / exposed
    14 / 50 (28.00%)
    18 / 52 (34.62%)
         occurrences all number
    16
    19
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    4 / 50 (8.00%)
    1 / 52 (1.92%)
         occurrences all number
    4
    1
    Oedema peripheral
         subjects affected / exposed
    5 / 50 (10.00%)
    3 / 52 (5.77%)
         occurrences all number
    6
    3
    Pain
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
         occurrences all number
    4
    1
    Pyrexia
         subjects affected / exposed
    13 / 50 (26.00%)
    11 / 52 (21.15%)
         occurrences all number
    14
    13
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    3 / 50 (6.00%)
    9 / 52 (17.31%)
         occurrences all number
    3
    9
    Dyspnoea
         subjects affected / exposed
    3 / 50 (6.00%)
    2 / 52 (3.85%)
         occurrences all number
    3
    2
    Hiccups
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
         occurrences all number
    3
    1
    Hypoxia
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 52 (7.69%)
         occurrences all number
    2
    5
    Pleural effusion
         subjects affected / exposed
    5 / 50 (10.00%)
    3 / 52 (5.77%)
         occurrences all number
    5
    4
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    3 / 50 (6.00%)
    6 / 52 (11.54%)
         occurrences all number
    3
    7
    Hallucination
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
         occurrences all number
    3
    1
    Insomnia
         subjects affected / exposed
    5 / 50 (10.00%)
    1 / 52 (1.92%)
         occurrences all number
    6
    1
    Investigations
    Blood lactic acid increased
         subjects affected / exposed
    4 / 50 (8.00%)
    6 / 52 (11.54%)
         occurrences all number
    4
    6
    International normalised ratio increased
         subjects affected / exposed
    4 / 50 (8.00%)
    2 / 52 (3.85%)
         occurrences all number
    4
    2
    Urine output decreased
         subjects affected / exposed
    4 / 50 (8.00%)
    3 / 52 (5.77%)
         occurrences all number
    4
    4
    Injury, poisoning and procedural complications
    Post procedural bile leak
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 52 (5.77%)
         occurrences all number
    2
    3
    Postoperative ileus
         subjects affected / exposed
    3 / 50 (6.00%)
    4 / 52 (7.69%)
         occurrences all number
    3
    4
    Procedural pain
         subjects affected / exposed
    5 / 50 (10.00%)
    10 / 52 (19.23%)
         occurrences all number
    5
    11
    Wound secretion
         subjects affected / exposed
    3 / 50 (6.00%)
    4 / 52 (7.69%)
         occurrences all number
    3
    4
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 52 (7.69%)
         occurrences all number
    2
    5
    Bradycardia
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 52 (5.77%)
         occurrences all number
    1
    3
    Tachycardia
         subjects affected / exposed
    4 / 50 (8.00%)
    11 / 52 (21.15%)
         occurrences all number
    4
    11
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 50 (12.00%)
    6 / 52 (11.54%)
         occurrences all number
    6
    7
    Lethargy
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 52 (5.77%)
         occurrences all number
    1
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 50 (8.00%)
    5 / 52 (9.62%)
         occurrences all number
    4
    5
    Leukocytosis
         subjects affected / exposed
    3 / 50 (6.00%)
    2 / 52 (3.85%)
         occurrences all number
    3
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 52 (5.77%)
         occurrences all number
    3
    3
    Abdominal pain
         subjects affected / exposed
    5 / 50 (10.00%)
    7 / 52 (13.46%)
         occurrences all number
    5
    10
    Abdominal pain upper
         subjects affected / exposed
    4 / 50 (8.00%)
    1 / 52 (1.92%)
         occurrences all number
    4
    1
    Ascites
         subjects affected / exposed
    5 / 50 (10.00%)
    3 / 52 (5.77%)
         occurrences all number
    5
    3
    Constipation
         subjects affected / exposed
    14 / 50 (28.00%)
    22 / 52 (42.31%)
         occurrences all number
    19
    25
    Diarrhoea
         subjects affected / exposed
    3 / 50 (6.00%)
    7 / 52 (13.46%)
         occurrences all number
    3
    7
    Nausea
         subjects affected / exposed
    25 / 50 (50.00%)
    23 / 52 (44.23%)
         occurrences all number
    30
    30
    Small intestinal obstruction
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
         occurrences all number
    3
    0
    Vomiting
         subjects affected / exposed
    13 / 50 (26.00%)
    14 / 52 (26.92%)
         occurrences all number
    15
    16
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    6 / 50 (12.00%)
    7 / 52 (13.46%)
         occurrences all number
    6
    7
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 52 (5.77%)
         occurrences all number
    2
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 52 (7.69%)
         occurrences all number
    2
    4
    Musculoskeletal pain
         subjects affected / exposed
    8 / 50 (16.00%)
    5 / 52 (9.62%)
         occurrences all number
    8
    5
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 50 (6.00%)
    3 / 52 (5.77%)
         occurrences all number
    3
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 50 (4.00%)
    5 / 52 (9.62%)
         occurrences all number
    3
    5
    Wound infection
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 52 (5.77%)
         occurrences all number
    1
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 52 (5.77%)
         occurrences all number
    1
    3
    Hyperglycaemia
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    3
    Hyperkalaemia
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 52 (7.69%)
         occurrences all number
    2
    4
    Hypokalaemia
         subjects affected / exposed
    12 / 50 (24.00%)
    11 / 52 (21.15%)
         occurrences all number
    13
    11
    Hypomagnesaemia
         subjects affected / exposed
    12 / 50 (24.00%)
    12 / 52 (23.08%)
         occurrences all number
    14
    13
    Hypophosphataemia
         subjects affected / exposed
    11 / 50 (22.00%)
    11 / 52 (21.15%)
         occurrences all number
    12
    11
    Malnutrition
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
         occurrences all number
    3
    0
    Vitamin D deficiency
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
         occurrences all number
    3
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2014
    Addition of DMC and CEC details to the protocol along with other various clarifications and improvements to grammar.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA