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    Clinical Trial Results:
    Safety and efficacy of subcutaneous (SC) administration of Clinimix N9G15E in elderly patients at risk for malnutrition, at a dose of 1 liter infused over 12 hours for 7 to 10 consecutive days. A prospective, multicentre, randomized, open-label, non-inferiority, controlled phase III B trial carried out in parallel groups: subcutaneous versus peripheral intravenous administration.

    Summary
    EudraCT number
    		 2007-006153-31
    Trial protocol
    		 FR  
    Global end of trial date
    09 Apr 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Apr 2018
    First version publication date
    21 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CSC/P01/07/Mu.F
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Baxter Healthcare Corporation
    Sponsor organisation address
    1 Baxter Parkway, Deerfield, United States, 60015
    Public contact
    Clinical Trials Disclosure Call Center, Baxter Healthcare Corporation, Global_CORP_ClinicalTrialsDisclosure@baxter.com
    Scientific contact
    Clinical Trials Disclosure Call Center, Baxter Healthcare Corporation, Global_CORP_ClinicalTrialsDisclosure@baxter.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
    09 Apr 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Apr 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to demonstrate that the SC administration of 1 liter of Clinimix N9G15E is non-inferior to the peripheral IV administration of 1 liter of Clinimix N9g15E in terms of local side effects. The secondary objective was to assess safety and efficacy in terms of patients' nutritional parameters, clinical outcomes, and hydration status.
    Protection of trial subjects
    A patient could withdraw consent at any time for any reason. Patients were discontinued from the study if any of the following occurred during the course of the study: -Patient required enteral or other parenteral administration. -Patient or patient's legal authorized representative withdrew consent. -Patient enrolled in any other investigational study. -Onset of any serious or life threatening adverse event requiring discontinuation of study treatment. -Investigator's decision. -In case of the need for a second administration route switch. -Patient required therapeutic anticoagulation after enrollment in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jul 2008
    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
    France: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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
    100
    85 years and over
    20

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study population (geriatric) chosen represented one population with difficult venous access and where SC hydration has been effective. The population contained patients with many different disorders. Other populations with difficult venous access may benefit from the therapy (the study was not meant to be exclusive of other populations).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SC Treatment
    Arm description
    		 Subcutaneous (SC) Treatment of Clinimix N9G15E at a dose of 1 liter was infused subcutaneously over 12 hours for at least 7 and up to 10 consecutive days. Infusion sites included abdominal area, thighs, back and chest and were to be changed after administration of each 1 liter bag. Subcutaneous infusions were administered with a 21 to 25 G butterfly needle or catheter.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clinimix N9G15E Subcutaneous
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The Clinimix N9G15E 1 L bag contained 27.5 g amino acids with electrolytes (Na, K, Ca, Mg, and PO4) and 75 g glucose, in separate chambers, providing a total of 410 kcal/L. The final osmolarity (after mixing) was 845 mOsm/L. All 1000 mL were planned to be infused over 12 hours, resulting in a rate of infusion of approximately 83 to 84 mL/hour, not exceeding a rate of 3 mL/kg/hour.

    Arm title
    		 IV Treatment
    Arm description
    		 Intravenous (IV) Treatment of Clinimix N9G15E at a dose of 1 liter was infused via peripheral IV over 12 hours for at least 7 and up to 10 consecutive days. Peripheral IV drips were to be changed by the local implementation of the local Comite' de Liaison en Alimentation et Nutrition (CLAN) recommendations. The peripheral IV lines used for administration of Clinimix were to be used only for administration of the study test product. After administration of the final dose of test product, the peripheral IV line was to be removed and the injection site was not to be used for 48 hours.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Clinimix N9G15E Intravenous
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    The Clinimix N9G15E 1 L bag contained 27.5 g amino acids with electrolytes (Na, K, Ca, Mg, and PO4) and 75 g glucose, in separate chambers, providing a total of 410 kcal/L. The final osmolarity (after mixing) was 845 mOsm/L. All 1000 mL were planned to be infused over 12 hours, resulting in a rate of infusion of approximately 83 to 84 mL/hour, not exceeding a rate of 3 mL/kg/hour.

    Number of subjects in period 1
    		SC Treatment IV Treatment
    Started
    59
    61
    Completed
    49
    53
    Not completed
    10
    8
         Consent withdrawn by subject
    3
    1
         Clinical adverse event
    3
    3
         Deaths
    1
    1
         Unknown
    2
    1
         Protocol Noncompliance
    -
    1
         Biological adverse event
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SC Treatment
    Reporting group description
    		 Subcutaneous (SC) Treatment of Clinimix N9G15E at a dose of 1 liter was infused subcutaneously over 12 hours for at least 7 and up to 10 consecutive days. Infusion sites included abdominal area, thighs, back and chest and were to be changed after administration of each 1 liter bag. Subcutaneous infusions were administered with a 21 to 25 G butterfly needle or catheter.

    Reporting group title
    IV Treatment
    Reporting group description
    		 Intravenous (IV) Treatment of Clinimix N9G15E at a dose of 1 liter was infused via peripheral IV over 12 hours for at least 7 and up to 10 consecutive days. Peripheral IV drips were to be changed by the local implementation of the local Comite' de Liaison en Alimentation et Nutrition (CLAN) recommendations. The peripheral IV lines used for administration of Clinimix were to be used only for administration of the study test product. After administration of the final dose of test product, the peripheral IV line was to be removed and the injection site was not to be used for 48 hours.

    Reporting group values
    		 SC Treatment IV Treatment Total
    Number of subjects
    		 59 61 120
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 84.4 ( 6.14 ) 84.9 ( 5.92 ) -
    Gender categorical
    Units: Subjects
        Female
    		 34 44 78
        Male
    		 25 17 42

    End points

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    End points reporting groups
    Reporting group title
    SC Treatment
    Reporting group description
    		 Subcutaneous (SC) Treatment of Clinimix N9G15E at a dose of 1 liter was infused subcutaneously over 12 hours for at least 7 and up to 10 consecutive days. Infusion sites included abdominal area, thighs, back and chest and were to be changed after administration of each 1 liter bag. Subcutaneous infusions were administered with a 21 to 25 G butterfly needle or catheter.

    Reporting group title
    IV Treatment
    Reporting group description
    		 Intravenous (IV) Treatment of Clinimix N9G15E at a dose of 1 liter was infused via peripheral IV over 12 hours for at least 7 and up to 10 consecutive days. Peripheral IV drips were to be changed by the local implementation of the local Comite' de Liaison en Alimentation et Nutrition (CLAN) recommendations. The peripheral IV lines used for administration of Clinimix were to be used only for administration of the study test product. After administration of the final dose of test product, the peripheral IV line was to be removed and the injection site was not to be used for 48 hours.

    Primary: Number of Patients with at Least One Major Local Side Effect

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    End point title
    		 Number of Patients with at Least One Major Local Side Effect
    End point description
    Major local side effects were evaluated before the start of and at the end of an infusion. An event reported at the start of an infusion was allocated to the route of the previous administration as the "12 hour later" assessment. If an AE occurred before a change/switch of administration route, it was attributed to the previous route. The event was considered a major local side effect if, during the infusion that the major local side effect was attributed to, the subject was infused with a least 800mL of study product and the infusion was between 8 and 16 hours in duration. This endpoint was defined as the occurrence of at least 1 of the following: large edema (diameter>10cm); blistering (diameter>2cm); erythema (diameter>10cm); phlebitis; cellulitis; or strong (unbearable) pain.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 11
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: Patients
        number (not applicable)
    16
    27
    Statistical analysis title
    		 Stats 1
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.059
    Method
    		 Fisher exact
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.4

    Primary: Number of Patients by Major Local Side Effect Type

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    End point title
    		 Number of Patients by Major Local Side Effect Type
    End point description
    Large edema (diameter > 10 cm) Blistering (diameter > 2 cm) Erythema (diameter > 10 cm)
    End point type
    Primary
    End point timeframe
    Day 1 to Day 11
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: Patients
    number (not applicable)
        Large edema
    13
    5
        Blistering
    0
    0
        Erythema
    5
    2
        Unbearable pain
    0
    1
        Phlebitis
    1
    0
        Cellulitis
    1
    1
    Statistical analysis title
    		 Large edema
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.042
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Erythema
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.268
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Unbearable pain
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Phlebitis
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.492
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Cellulitis
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Change from Baseline in Body Weight at End of Treatment

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    End point title
    		 Change from Baseline in Body Weight at End of Treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment (Day 11)
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: Kilogram (kg)
        arithmetic mean (standard deviation)
    0.8 ( 2.26 )
    0.4 ( 1.60 )
    Statistical analysis title
    		 Stats 1
    Statistical analysis description
    Difference from Baseline to End of Treatment
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.453
    Method
    		 F-test
    Confidence interval

    Secondary: Change from Baseline in Body Mass Index (BMI) at End of Treatment

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    End point title
    		 Change from Baseline in Body Mass Index (BMI) at End of Treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Day 11)
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: kg/m2
        arithmetic mean (standard deviation)
    0.4 ( 0.94 )
    0.2 ( 0.62 )
    Statistical analysis title
    		 Stats 1
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.465
    Method
    		 F-test
    Confidence interval

    Secondary: Change from Baseline in Transthyretin at End of Treatment

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    End point title
    		 Change from Baseline in Transthyretin at End of Treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Day 11)
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: g/L
        arithmetic mean (standard deviation)
    0.02 ( 0.038 )
    0.01 ( 0.048 )
    Statistical analysis title
    		 Stats 1
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.26
    Method
    		 F-test
    Confidence interval

    Secondary: Change from Baseline in Albumin at End of Treatment

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    End point title
    		 Change from Baseline in Albumin at End of Treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Day 11)
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: g/L
        arithmetic mean (standard deviation)
    0 ( 3.6 )
    -0 ( 3.3 )
    Statistical analysis title
    		 Stats 1
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.854
    Method
    		 F-test
    Confidence interval

    Secondary: Change from Baseline in Transferrin at End of Treatment

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    End point title
    		 Change from Baseline in Transferrin at End of Treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Day 11)
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: umol/L
        arithmetic mean (standard deviation)
    2.1 ( 3.1 )
    0.4 ( 4.5 )
    Statistical analysis title
    		 Stats 1
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.17
    Method
    		 F-test
    Confidence interval

    Secondary: Change from Baseline in Lymphocytes at End of Treatment

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    End point title
    		 Change from Baseline in Lymphocytes at End of Treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Day 11)
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: cells/mm3
        arithmetic mean (standard deviation)
    -11 ( 533.1 )
    -69 ( 368.7 )
    Statistical analysis title
    		 Stats 1
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.567
    Method
    		 f-test
    Confidence interval

    Secondary: Change from Baseline in Clinical Laboratory Hydration Parameters

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    End point title
    		 Change from Baseline in Clinical Laboratory Hydration Parameters
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Day 11)
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: mmol/L
    arithmetic mean (standard deviation)
        Potassium
    0.24 ( 0.494 )
    0.23 ( 0.397 )
        Chloride
    0.0 ( 3.3 )
    0 ( 9.9 )
        Bicarbonate
    -0.4 ( 3.28 )
    0.7 ( 4.67 )
        Calcium
    0.04 ( 0.188 )
    0 ( 0.096 )
        Magnesium
    0.05 ( 0.089 )
    0.05 ( 0.082 )
        Phosphorus
    0.13 ( 0.245 )
    0.09 ( 0.184 )
        Glucose
    0.12 ( 2.244 )
    0.61 ( 2.112 )
    Statistical analysis title
    		 Potassium
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.63
    Method
    		 F-test
    Confidence interval
    Statistical analysis title
    		 Chloride
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.576
    Method
    		 F-test
    Confidence interval
    Statistical analysis title
    		 Bicarbonate
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.27
    Method
    		 F-test
    Confidence interval
    Statistical analysis title
    		 Calcium
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.611
    Method
    		 F-test
    Confidence interval
    Statistical analysis title
    		 Magnesium
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.935
    Method
    		 F-test
    Confidence interval
    Statistical analysis title
    		 Phosphorus
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.508
    Method
    		 F-test
    Confidence interval
    Statistical analysis title
    		 Glucose
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.386
    Method
    		 F-test
    Confidence interval

    Secondary: Adherence (by Days) to Assigned Administration Route

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    End point title
    		 Adherence (by Days) to Assigned Administration Route
    End point description
    Adherence to assigned administration route is defined as the number of days before any change/switch of administration route for patients who did experience a change/switch, or the total duration of treatment in days for patients who did not experience a change/switch.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 11
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: Days
        arithmetic mean (standard deviation)
    7.4 ( 2.4 )
    5.6 ( 3 )
    Statistical analysis title
    		 Stats 1
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 F-test
    Confidence interval

    Secondary: Length of Stay until Date of Discharge

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    End point title
    		 Length of Stay until Date of Discharge
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Day 11)
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: Days
        arithmetic mean (standard deviation)
    21.3 ( 13.2 )
    20.8 ( 13.6 )
    No statistical analyses for this end point

    Secondary: Length of Stay until Date Ready for Discharge

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    End point title
    		 Length of Stay until Date Ready for Discharge
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (Day 11)
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: Days
        arithmetic mean (standard deviation)
    20.2 ( 13.3 )
    22.3 ( 16.2 )
    No statistical analyses for this end point

    Secondary: Percentage of Patients by Destination at Discharge

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    End point title
    		 Percentage of Patients by Destination at Discharge
    End point description
    End point type
    Secondary
    End point timeframe
    Day 21/End of Study
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: Destination (location)
    number (not applicable)
        Home
    32.2
    24.6
        Nursing Home
    15.3
    14.8
        Chronic Care Facility
    15.3
    11.5
        Other
    28.8
    39.3
        Remain in Ward
    0
    0
        Unknown
    8.5
    9.8
    No statistical analyses for this end point

    Secondary: Patient Survival at End of Study

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    End point title
    		 Patient Survival at End of Study
    End point description
    End point type
    Secondary
    End point timeframe
    Day 21/End of Study
    End point values
    		 SC Treatment IV Treatment
    Number of subjects analysed
    59
    61
    Units: Patients
    number (not applicable)
        Deaths
    3
    5
        Censored
    56
    56
    Statistical analysis title
    		 Stats 1
    Comparison groups
    SC Treatment v IV Treatment
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 11.9

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment Emergent
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11
    Reporting groups
    Reporting group title
    SC Before or During Switch or Route
    Reporting group description
    		 -

    Reporting group title
    IV Before or During Switch or Route
    Reporting group description
    		 -

    Reporting group title
    SC after switch of route
    Reporting group description
    		 -

    Serious adverse events
    		 SC Before or During Switch or Route IV Before or During Switch or Route SC after switch of route
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 61 (11.48%)
    6 / 59 (10.17%)
    3 / 21 (14.29%)
         number of deaths (all causes)
    3
    4
    1
         number of deaths resulting from adverse events
    3
    4
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    COLORECTAL CANCER
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    OESOPHAGEAL CARCINOMA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Vascular disorders
    ARTERIAL DISORDER
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    THROMBOPHLEBITIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CARDIAC FAILURE ACUTE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    General disorders and administration site conditions
    GENERAL PHYSICAL HEALTH DETERIORATION
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 59 (3.39%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    PULMONARY EMBOLISM
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    RENAL FAILURE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RENAL FAILURE ACUTE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SEPTIC SHOCK
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    DIABETES MELLITUS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HYPERKALAEMIA
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.1%
    Non-serious adverse events
    		 SC Before or During Switch or Route IV Before or During Switch or Route SC after switch of route
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 61 (68.85%)
    37 / 59 (62.71%)
    11 / 21 (52.38%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    COLORECTAL CANCER
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    OESOPHAGEAL CARCINOMA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    ARTERIAL DISORDER
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    POOR VENOUS ACCESS
         subjects affected / exposed
    0 / 61 (0.00%)
    4 / 59 (6.78%)
    0 / 21 (0.00%)
         occurrences all number
    0
    4
    0
    THROMBOPHLEBITIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    GENERAL PHYSICAL HEALTH DETERIORATION
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 59 (3.39%)
    0 / 21 (0.00%)
         occurrences all number
    1
    2
    0
    HYPERTHERMIA
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    INFLAMMATION
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    INFUSION SITE CELLULITIS
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    INFUSION SITE ERYTHEMA
         subjects affected / exposed
    5 / 61 (8.20%)
    3 / 59 (5.08%)
    0 / 21 (0.00%)
         occurrences all number
    8
    3
    0
    INFUSION SITE EXTRAVASATION
         subjects affected / exposed
    0 / 61 (0.00%)
    2 / 59 (3.39%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    INFUSION SITE HAEMATOMA
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    INFUSION SITE INFLAMMATION
         subjects affected / exposed
    0 / 61 (0.00%)
    8 / 59 (13.56%)
    0 / 21 (0.00%)
         occurrences all number
    0
    9
    0
    INFUSION SITE OEDEMA
         subjects affected / exposed
    19 / 61 (31.15%)
    7 / 59 (11.86%)
    5 / 21 (23.81%)
         occurrences all number
    42
    7
    11
    INFUSION SITE PAIN
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 59 (5.08%)
    2 / 21 (9.52%)
         occurrences all number
    1
    5
    2
    INFUSION SITE REACTION
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    INFUSION SITE VESICLES
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    PYREXIA
         subjects affected / exposed
    2 / 61 (3.28%)
    2 / 59 (3.39%)
    0 / 21 (0.00%)
         occurrences all number
    2
    2
    0
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    EPISTAXIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    LUNG DISORDER
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    PULMONARY EMBOLISM
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    DEPRESSION
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    INSOMNIA
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    0 / 61 (0.00%)
    2 / 59 (3.39%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    BLOOD UREA INCREASED
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    THYROXINE FREE INCREASED
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    WEIGHT DECREASED
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    DUST INHALATION PNEUMOPATHY
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    SYNCOPE
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    CARDIAC DISORDERS
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 59 (5.08%)
    1 / 21 (4.76%)
         occurrences all number
    1
    3
    1
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    CARDIAC FAILURE
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    CARDIAC FAILURE ACUTE
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    CONJUNCTIVITIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    CONSTIPATION
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 59 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    2
    0
    2
    DIARRHOEA
         subjects affected / exposed
    4 / 61 (6.56%)
    2 / 59 (3.39%)
    0 / 21 (0.00%)
         occurrences all number
    4
    2
    0
    NAUSEA
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 59 (3.39%)
    0 / 21 (0.00%)
         occurrences all number
    1
    2
    0
    VOMITING
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    MUCOCUTANEOUS RASH
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    HAEMATURIA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    RENAL FAILURE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    RENAL FAILURE ACUTE
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    URINARY RETENTION
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    MUSCLE SPASMS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    NECK PAIN
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    BRONCHOPNEUMONIA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    ERYSIPELAS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    FUNGAL INFECTION
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    2
    1
    0
    GASTROENTERITIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    HELICOBACTER GASTRITIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    LYMPHANGITIS
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    PNEUMONIA
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    PYELONEPHRITIS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    SEPTIC SHOCK
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    SKIN INFECTION
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    2
    1
    0
    VULVOVAGINAL MYCOTIC INFECTION
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    2
    1
    0
    DIABETES MELLITUS
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    HYPERGLYCAEMIA
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    HYPERKALAEMIA
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 59 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    2
    0
    1
    HYPOKALAEMIA
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    HYPONATRAEMIA
         subjects affected / exposed
    2 / 61 (3.28%)
    2 / 59 (3.39%)
    0 / 21 (0.00%)
         occurrences all number
    2
    2
    0
    MALNUTRITION
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    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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