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    Clinical Trial Results:
    A controlled, randomized, multi-centre, double blind, phase II study to evaluate efficacy and safety of topical PeproStat in intraoperative surgical haemostasis

    Summary
    EudraCT number
    		 2016-003661-26
    Trial protocol
    		 GB   PL   HR  
    Global end of trial date
    23 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2018
    First version publication date
    08 Sep 2018
    Other versions
    Summary report(s)
    		 CSR Synopsis

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    HX-02-PEP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03131336
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Haemostatix Limited
    Sponsor organisation address
    BioCity Nottingham, Nottingham, United Kingdom, NG1 1GF
    Public contact
    Information point, Haemostatix Limited, 0044 1159124512, info@ergomedplc.com
    Scientific contact
    Information point, Haemostatix Limited, 0044 1159124512, info@ergomedplc.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
    10 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the efficacy of PeproStat in intraoperative hemostasis in adult subjects who underwent liver/soft tissue surgery, vascular surgery or spine surgery.
    Protection of trial subjects
    The study was conducted according to the protocol and in compliance with Good Clinical Practice (GCP), with the Declaration of Helsinki and with other applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 2017
    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
    Bosnia and Herzegovina: 91
    Country: Number of subjects enrolled
    Serbia: 66
    Country: Number of subjects enrolled
    Poland: 28
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    Croatia: 14
    Worldwide total number of subjects
    214
    EEA total number of subjects
    57
    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)
    122
    From 65 to 84 years
    90
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment started on 31 March 2017 and was completed on 14 July 2017. Subjects from Serbia, Croatia, Bosnia and Herzegovina, Poland, and UK were recruited into the study.

    Pre-assignment
    Screening details
    		 A total of 214 subjects were consented and screened, 203 subjects were randomised and 169 received treatment. 11 subjects were screen failures and 34 were extended screen failures (did not require a haemostat during their surgery).

    Period 1
    Period 1 title
    Interventional study period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gelatine sponge soaked in Peprostat
    Arm description
    		 PeproStat 2.5 mg/mL (Investigational Product), soaked into absorbable haemostatic gelatin sponge (Spongostan).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peprostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for sealant
    Routes of administration
    Epilesional use
    Dosage and administration details
    The dosage was 12.5 mg per vial. The gelatine sponge was soaked with 1 vial; 5 mL 2.5 mg/mL PeproStat (12.5 mg nominal dose), moments before topical application to the target bleeding site during scheduled liver/soft tissue, vascular, or spine surgery. A maximum of 2 PeproStat soaked sponges could be used in each subject as appropriate for the size / number of bleeding sites.

    Arm title
    		 Gelatin sponge soaked in Saline
    Arm description
    		 Saline 0.9% (control product), soaked into absorbable haemostatic gelatin sponge (Spongostan).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Saline 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Epilesional use
    Dosage and administration details
    Each vial contained 5mL of 0.9% saline The gelatine sponge was soaked with 1 vial; 5 mL of 0.9% saline, moments before topical application to the target bleeding site during scheduled liver/soft tissue, vascular, or spine surgery. A maximum of 2 saline soaked sponges could be used in each subject as appropriate for the size / number of bleeding sites.

    Number of subjects in period 1 [1]
    		Gelatine sponge soaked in Peprostat Gelatin sponge soaked in Saline
    Started
    114
    55
    Completed
    114
    55
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number enrolled is all those who have signed the ICF. The number reported in the baseline period are the number treated.
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gelatine sponge soaked in Peprostat
    Arm description
    		 PeproStat 2.5 mg/mL (Investigational Product), soaked into absorbable haemostatic gelatin sponge (Spongostan).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peprostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for sealant
    Routes of administration
    Epilesional use
    Dosage and administration details
    The dosage was 12.5 mg per vial. The gelatine sponge was soaked with 1 vial; 5 mL 2.5 mg/mL PeproStat (12.5 mg nominal dose), moments before topical application to the target bleeding site during scheduled liver/soft tissue, vascular, or spine surgery. A maximum of 2 PeproStat soaked sponges could be used in each subject as appropriate for the size / number of bleeding sites.

    Arm title
    		 Gelatin sponge soaked in Saline
    Arm description
    		 Saline 0.9% (control product), soaked into absorbable haemostatic gelatin sponge (Spongostan).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Saline 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Epilesional use
    Dosage and administration details
    Each vial contained 5mL of 0.9% saline The gelatine sponge was soaked with 1 vial; 5 mL of 0.9% saline, moments before topical application to the target bleeding site during scheduled liver/soft tissue, vascular, or spine surgery. A maximum of 2 saline soaked sponges could be used in each subject as appropriate for the size / number of bleeding sites.

    Number of subjects in period 2
    		Gelatine sponge soaked in Peprostat Gelatin sponge soaked in Saline
    Started
    114
    55
    Completed
    112
    53
    Not completed
    2
    2
         Adverse event, serious fatal
    1
    -
         Lost to follow-up
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gelatine sponge soaked in Peprostat
    Reporting group description
    		 PeproStat 2.5 mg/mL (Investigational Product), soaked into absorbable haemostatic gelatin sponge (Spongostan).

    Reporting group title
    Gelatin sponge soaked in Saline
    Reporting group description
    		 Saline 0.9% (control product), soaked into absorbable haemostatic gelatin sponge (Spongostan).

    Reporting group values
    		 Gelatine sponge soaked in Peprostat Gelatin sponge soaked in Saline Total
    Number of subjects
    		 114 55 169
    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
    Overall in the study the mean (SD) age was 61.3 (11.84) years. The mean (SD) ages were similar between PeproStat and Saline treatment groups within a surgery type, but mean (SD) age was lowest in subjects who underwent spine surgery (56.4 [10.93] years) and highest in subjects who underwent vascular surgery (68.1 [9.16] years).
    Units: years
        arithmetic mean (standard deviation)
    		 61.3 ( 11.55 ) 61.3 ( 12.52 ) -
    Gender categorical
    Overall in the study, sex was almost split 1:1 between females (52.7%) and males (47.3%). However, sex stratified by surgery type revealed that approximately twice as many females underwent open liver/soft tissue surgery and spine surgery, while twice as many males underwent vascular surgery. The treatment groups within each surgery type followed the same patterns.
    Units: Subjects
        Female
    		 58 31 89
        Male
    		 56 24 80
    Subject analysis sets

    Subject analysis set title
    FAS - Peprostat - open liver/soft tissue surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing open liver/soft tissue surgery who received Peprostat

    Subject analysis set title
    PP - Peprostat - open liver/soft tissue surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation and who underwent open liver/soft tissue surgery and received Peprostat.

    Subject analysis set title
    FAS - Peprostat - vascular surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing vascular surgery who received Peprostat

    Subject analysis set title
    FAS - Peprostat - spine surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing spine surgery who received Peprostat

    Subject analysis set title
    PP - Preprostat - vascular surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who underwent vascular surgery and received Peprostat.

    Subject analysis set title
    PP - Peprostat - spine surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who underwent spine surgery and received Peprostat.

    Subject analysis set title
    FAS - Saline- open liver/soft tissue surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing open liver/soft tissue surgery who received control treatment

    Subject analysis set title
    PP - Saline - open liver/soft tissue surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who underwent open liver/soft tissue surgery and received control treatment.

    Subject analysis set title
    FAS - Saline - vascular surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing vascular surgery who received control treatment

    Subject analysis set title
    PP - Saline - vascular surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who underwent vascular surgery and received control treatment.

    Subject analysis set title
    FAS - Saline - spine surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing spine surgery who received control treatment

    Subject analysis set title
    PP - Saline - spine surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who underwent spine surgery and received control treatment

    Subject analysis set title
    FAS - Peprostat - All surgeries
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing any of the surgeries who received Peprostat

    Subject analysis set title
    FAS - Saline - All surgeries
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing any of the surgeries who received control treatment

    Subject analysis set title
    PP - Peprostat - All surgeries
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who received Peprostat

    Subject analysis set title
    PP - Saline - All surgeries
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who received control treatment

    Subject analysis set title
    FAS - Peprostat all surgeries - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing all surgeries who received control Peprostat and who experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Saline all surgeries - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing all surgeries who received control and experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Peprostat vascular surgery- mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing vascular surgery who received Peprostat and experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Peprostat open liver/soft tissue - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing open liver/soft tissue surgery who received Peprostat and experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Peprostat spine surgery - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing spine surgery who received Peprostat and experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Saline open liver/soft tissue - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing open liver / soft tissue surgery who received control treatment and experienced mild bleeding in surgery

    Subject analysis set title
    FAS - Saline spine surgery - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing spine surgery who received control treatment and experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Saline vascular surgery - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing vascular surgery who received control treatment and experienced mild bleeding during surgery

    Subject analysis sets values
    		 FAS - Peprostat - open liver/soft tissue surgery PP - Peprostat - open liver/soft tissue surgery FAS - Peprostat - vascular surgery FAS - Peprostat - spine surgery PP - Preprostat - vascular surgery PP - Peprostat - spine surgery FAS - Saline- open liver/soft tissue surgery PP - Saline - open liver/soft tissue surgery FAS - Saline - vascular surgery PP - Saline - vascular surgery FAS - Saline - spine surgery PP - Saline - spine surgery FAS - Peprostat - All surgeries FAS - Saline - All surgeries PP - Peprostat - All surgeries PP - Saline - All surgeries FAS - Peprostat all surgeries - mild bleeding FAS - Saline all surgeries - mild bleeding FAS - Peprostat vascular surgery- mild bleeding FAS - Peprostat open liver/soft tissue - mild bleeding FAS - Peprostat spine surgery - mild bleeding FAS - Saline open liver/soft tissue - mild bleeding FAS - Saline spine surgery - mild bleeding FAS - Saline vascular surgery - mild bleeding
    Number of subjects
    39
    37
    36
    39
    35
    38
    19
    17
    18
    18
    18
    17
    114
    55
    110
    52
    47
    26
    20
    11
    16
    9
    4
    13
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Overall in the study the mean (SD) age was 61.3 (11.84) years. The mean (SD) ages were similar between PeproStat and Saline treatment groups within a surgery type, but mean (SD) age was lowest in subjects who underwent spine surgery (56.4 [10.93] years) and highest in subjects who underwent vascular surgery (68.1 [9.16] years).
    Units: years
        arithmetic mean (standard deviation)
    60.9 ( 10.98 )
    60.7 ( 10.22 )
    68.2 ( 9.07 )
    55.4 ( 10.96 )
    68.6 ( 8.92 )
    55.4 ( 11.10 )
    57.6 ( 14.25 )
    55.6 ( 13.81 )
    68.0 ( 9.60 )
    68.0 ( 9.6 )
    58.4 ( 10.89 )
    57.8 ( 10.88 )
    61.3 ( 11.55 )
    61.3 ( 12.52 )
    61.4 ( 11.42 )
    60.6 ( 12.57 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Overall in the study, sex was almost split 1:1 between females (52.7%) and males (47.3%). However, sex stratified by surgery type revealed that approximately twice as many females underwent open liver/soft tissue surgery and spine surgery, while twice as many males underwent vascular surgery. The treatment groups within each surgery type followed the same patterns.
    Units: Subjects
        Female
    27
    26
    6
    25
    6
    24
    14
    14
    6
    6
    11
    10
    58
    31
    56
    30
        Male
    12
    11
    30
    14
    29
    14
    5
    3
    12
    12
    7
    7
    56
    24
    54
    22

    End points

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    End points reporting groups
    Reporting group title
    Gelatine sponge soaked in Peprostat
    Reporting group description
    		 PeproStat 2.5 mg/mL (Investigational Product), soaked into absorbable haemostatic gelatin sponge (Spongostan).

    Reporting group title
    Gelatin sponge soaked in Saline
    Reporting group description
    		 Saline 0.9% (control product), soaked into absorbable haemostatic gelatin sponge (Spongostan).
    Reporting group title
    Gelatine sponge soaked in Peprostat
    Reporting group description
    		 PeproStat 2.5 mg/mL (Investigational Product), soaked into absorbable haemostatic gelatin sponge (Spongostan).

    Reporting group title
    Gelatin sponge soaked in Saline
    Reporting group description
    		 Saline 0.9% (control product), soaked into absorbable haemostatic gelatin sponge (Spongostan).

    Subject analysis set title
    FAS - Peprostat - open liver/soft tissue surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing open liver/soft tissue surgery who received Peprostat

    Subject analysis set title
    PP - Peprostat - open liver/soft tissue surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation and who underwent open liver/soft tissue surgery and received Peprostat.

    Subject analysis set title
    FAS - Peprostat - vascular surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing vascular surgery who received Peprostat

    Subject analysis set title
    FAS - Peprostat - spine surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing spine surgery who received Peprostat

    Subject analysis set title
    PP - Preprostat - vascular surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who underwent vascular surgery and received Peprostat.

    Subject analysis set title
    PP - Peprostat - spine surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who underwent spine surgery and received Peprostat.

    Subject analysis set title
    FAS - Saline- open liver/soft tissue surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing open liver/soft tissue surgery who received control treatment

    Subject analysis set title
    PP - Saline - open liver/soft tissue surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who underwent open liver/soft tissue surgery and received control treatment.

    Subject analysis set title
    FAS - Saline - vascular surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing vascular surgery who received control treatment

    Subject analysis set title
    PP - Saline - vascular surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who underwent vascular surgery and received control treatment.

    Subject analysis set title
    FAS - Saline - spine surgery
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing spine surgery who received control treatment

    Subject analysis set title
    PP - Saline - spine surgery
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who underwent spine surgery and received control treatment

    Subject analysis set title
    FAS - Peprostat - All surgeries
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing any of the surgeries who received Peprostat

    Subject analysis set title
    FAS - Saline - All surgeries
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing any of the surgeries who received control treatment

    Subject analysis set title
    PP - Peprostat - All surgeries
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who received Peprostat

    Subject analysis set title
    PP - Saline - All surgeries
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol set is all patients that did not have protocol deviations that could have an effect on the efficacy and safety evaluation who received control treatment

    Subject analysis set title
    FAS - Peprostat all surgeries - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing all surgeries who received control Peprostat and who experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Saline all surgeries - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing all surgeries who received control and experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Peprostat vascular surgery- mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing vascular surgery who received Peprostat and experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Peprostat open liver/soft tissue - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing open liver/soft tissue surgery who received Peprostat and experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Peprostat spine surgery - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing spine surgery who received Peprostat and experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Saline open liver/soft tissue - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing open liver / soft tissue surgery who received control treatment and experienced mild bleeding in surgery

    Subject analysis set title
    FAS - Saline spine surgery - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing spine surgery who received control treatment and experienced mild bleeding during surgery

    Subject analysis set title
    FAS - Saline vascular surgery - mild bleeding
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set represents the planned treatments for patients undergoing vascular surgery who received control treatment and experienced mild bleeding during surgery

    Primary: Time to haemostasis (TTH) at the primary target bleed site (TBS)

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    End point title
    		 Time to haemostasis (TTH) at the primary target bleed site (TBS)
    End point description
    Observations were performed at 1, 2, 3, 5, 7 and 10 minutes following application of study treatment. If bleeding stopped during the 10-minute assessment period, time to haemostasis was recorded.
    End point type
    Primary
    End point timeframe
    Within 10 minutes or to the end of the 10-minute assessment
    End point values
    		 FAS - Peprostat - open liver/soft tissue surgery PP - Peprostat - open liver/soft tissue surgery FAS - Peprostat - vascular surgery FAS - Peprostat - spine surgery PP - Preprostat - vascular surgery PP - Peprostat - spine surgery FAS - Saline- open liver/soft tissue surgery PP - Saline - open liver/soft tissue surgery FAS - Saline - vascular surgery PP - Saline - vascular surgery FAS - Saline - spine surgery PP - Saline - spine surgery FAS - Peprostat - All surgeries FAS - Saline - All surgeries PP - Peprostat - All surgeries PP - Saline - All surgeries
    Number of subjects analysed
    39
    37
    36
    39
    35
    38
    19
    17
    18
    18
    18
    17
    114
    55
    110
    52
    Units: minutes
        arithmetic mean (standard deviation)
    5.5 ( 3.03 )
    5.4 ( 3.02 )
    3.6 ( 2.90 )
    3.7 ( 2.78 )
    3.6 ( 2.93 )
    3.7 ( 2.82 )
    5.8 ( 3.22 )
    6.3 ( 3.08 )
    5.4 ( 3.85 )
    5.4 ( 3.85 )
    5.7 ( 3.51 )
    5.6 ( 3.60 )
    4.3 ( 3.01 )
    5.7 ( 3.47 )
    4.2 ( 3.01 )
    5.8 ( 3.48 )
    Statistical analysis title
    		 Time to Haemostasis
    Comparison groups
    FAS - Peprostat - open liver/soft tissue surgery v FAS - Peprostat - vascular surgery v FAS - Peprostat - spine surgery v FAS - Saline- open liver/soft tissue surgery v FAS - Saline - vascular surgery v FAS - Saline - spine surgery
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Median Time to Haemostasis

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    End point title
    		 Median Time to Haemostasis
    End point description
    End point type
    Secondary
    End point timeframe
    Median time to haemostasis in minutes from TxStart to the achievement of haemostasis or to the end of the 10-minute assessment period if haemostasis had not yet been achieved.
    End point values
    		 FAS - Peprostat - open liver/soft tissue surgery PP - Peprostat - open liver/soft tissue surgery FAS - Peprostat - vascular surgery FAS - Peprostat - spine surgery PP - Preprostat - vascular surgery PP - Peprostat - spine surgery FAS - Saline- open liver/soft tissue surgery PP - Saline - open liver/soft tissue surgery FAS - Saline - vascular surgery PP - Saline - vascular surgery FAS - Saline - spine surgery PP - Saline - spine surgery FAS - Peprostat - All surgeries FAS - Saline - All surgeries PP - Peprostat - All surgeries PP - Saline - All surgeries
    Number of subjects analysed
    39
    37
    36
    39
    35
    38
    19
    17
    18
    18
    18
    17
    114
    55
    110
    52
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    5.00 (3.00 to 7.00)
    5.00 (3.00 to 7.00)
    2.50 (1.50 to 5.00)
    3.00 (2.00 to 5.00)
    2.00 (1.00 to 5.00)
    2.50 (2.00 to 5.00)
    5.00 (3.00 to 10.00)
    5.00 (5.00 to 10.00)
    5.00 (2.00 to 10.00)
    5.00 (2.00 to 10.00)
    5.00 (3.00 to 10.00)
    5.00 (3.00 to 10.00)
    3.00 (2.00 to 6.00)
    5.00 (3.00 to 10.00)
    3.00 (2.00 to 6.00)
    5.00 (3.00 to 10.00)
    No statistical analyses for this end point

    Post-hoc: Post hoc analysis for subjects with mild bleeding

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    End point title
    		 Post hoc analysis for subjects with mild bleeding
    End point description
    Overall, 56.8% of subjects presented moderate bleeding and 43.2% of subjects presented mild bleeding in the FAS. For both open liver/soft tissue surgery and spine surgery most subjects presented moderate bleeding, whilst for vascular surgery the majority of subjects presented mild bleeding. Therefore, a Post-Hoc analysis was conducted to analyse and compare bleeding time in subjects who presented mild and moderate bleeding in the same manner as conducted in comparable trials.
    End point type
    Post-hoc
    End point timeframe
    Within 10 minutes or to the end of the 10-minute assessment
    End point values
    		 FAS - Peprostat all surgeries - mild bleeding FAS - Saline all surgeries - mild bleeding FAS - Peprostat vascular surgery- mild bleeding FAS - Peprostat open liver/soft tissue - mild bleeding FAS - Peprostat spine surgery - mild bleeding FAS - Saline open liver/soft tissue - mild bleeding FAS - Saline spine surgery - mild bleeding FAS - Saline vascular surgery - mild bleeding
    Number of subjects analysed
    47
    26
    20
    11
    16
    9
    4
    13
    Units: minutes
        arithmetic mean (standard deviation)
    3.2 ( 2.10 )
    5.9 ( 3.57 )
    3.3 ( 2.40 )
    3.2 ( 1.54 )
    3.1 ( 2.16 )
    5.8 ( 3.67 )
    7.0 ( 3.56 )
    5.6 ( 3.73 )
    Statistical analysis title
    		 time to haemostasis in patients with mild bleeding
    Comparison groups
    FAS - Peprostat vascular surgery- mild bleeding v FAS - Peprostat open liver/soft tissue - mild bleeding v FAS - Peprostat spine surgery - mild bleeding v FAS - Saline open liver/soft tissue - mild bleeding v FAS - Saline spine surgery - mild bleeding v FAS - Saline vascular surgery - mild bleeding
    Number of subjects included in analysis
    73
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from patient informed consent to last visit (follow-up) at Day 30.
    Adverse event reporting additional description
    Adverse events reported spontaneously by the subject, in response to an open-ended question, or revealed by observation by the Investigator. AEs of Special Interest: transfusion requirement, re-bleed at the TBSs during surgery and re-operation due to re-bleed at the TBS.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    safety population - Peprostat - all surgeries
    Reporting group description
    		 This group is the patients who underwent surgery (all types) and received treatment with Peprostat. One subject, who underwent scheduled spine surgery, was randomised to receive PeproStat, but actually received Saline. This is why there are 113 subjects in the safety group but 114 in the FAS (planned treatments).

    Reporting group title
    safety population - saline - all surgeries
    Reporting group description
    		 This group is the patients who underwent surgery (all types) and received treatment with the control (saline). One subject, who underwent scheduled spine surgery, was randomised to receive PeproStat, but actually received Saline. This is why there are 56 subjects in the safety group but 55 in the FAS (planned treatments).

    Reporting group title
    safety population - Peprostat - open liver/soft tissue surgery
    Reporting group description
    		 This group is the patients who underwent over liver / soft tissue surgery and received treatment with Peprostat

    Reporting group title
    safety population - saline - open liver/soft tissue surgery
    Reporting group description
    		 This group is the patients who underwent open liver / soft tissue surgery and received treatment with control (saline)

    Reporting group title
    safety population - Peprostat - vascular surgery
    Reporting group description
    		 This group is the patients who underwent vascular surgery and received treatment with Peprostat

    Reporting group title
    safety population - saline - vascular surgery
    Reporting group description
    		 This group is the patients who underwent vascular surgery and received treatment with control (saline)

    Reporting group title
    safety population - Peprostat - spine surgery
    Reporting group description
    		 This group is the patients who underwent spine surgery and received treatment with Peprostat

    Reporting group title
    safety population - saline - spine surgery
    Reporting group description
    		 This group is the patients who underwent spine surgery and received treatment with control (saline)

    Serious adverse events
    		 safety population - Peprostat - all surgeries safety population - saline - all surgeries safety population - Peprostat - open liver/soft tissue surgery safety population - saline - open liver/soft tissue surgery safety population - Peprostat - vascular surgery safety population - saline - vascular surgery safety population - Peprostat - spine surgery safety population - saline - spine surgery
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 113 (7.96%)
    3 / 56 (5.36%)
    2 / 39 (5.13%)
    1 / 19 (5.26%)
    6 / 36 (16.67%)
    1 / 18 (5.56%)
    1 / 38 (2.63%)
    1 / 19 (5.26%)
         number of deaths (all causes)
    1
    0
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    1
    0
    1
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Nerve injury
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 56 (1.79%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 56 (1.79%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Lymphorrhoea
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    1 / 38 (2.63%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 56 (1.79%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    1 / 39 (2.56%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Perihepatic abscess
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    1 / 39 (2.56%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 56 (1.79%)
    0 / 39 (0.00%)
    1 / 19 (5.26%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sepsis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 safety population - Peprostat - all surgeries safety population - saline - all surgeries safety population - Peprostat - open liver/soft tissue surgery safety population - saline - open liver/soft tissue surgery safety population - Peprostat - vascular surgery safety population - saline - vascular surgery safety population - Peprostat - spine surgery safety population - saline - spine surgery
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 113 (35.40%)
    17 / 56 (30.36%)
    7 / 39 (17.95%)
    2 / 19 (10.53%)
    17 / 36 (47.22%)
    8 / 18 (44.44%)
    16 / 38 (42.11%)
    7 / 19 (36.84%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 56 (3.57%)
    0 / 39 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    1
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    1 / 39 (2.56%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hypotension
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    1 / 38 (2.63%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Infusion site extravasation
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Chest pain
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    1 / 38 (2.63%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    Impaired healing
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    1 / 38 (2.63%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    1 / 39 (2.56%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Confusional state
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Investigations
    Blood count abnormal
         subjects affected / exposed
    6 / 113 (5.31%)
    1 / 56 (1.79%)
    2 / 39 (5.13%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    3 / 38 (7.89%)
    1 / 19 (5.26%)
         occurrences all number
    6
    1
    2
    0
    1
    0
    3
    1
    Haematocrit decreased
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 56 (3.57%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    2
    Blood albumin decreased
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Blood sodium decreased
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 56 (1.79%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    2
    0
    0
    Protein total decreased
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Red blood cell count decreased
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    1 / 38 (2.63%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Procedural haemorrhage
         subjects affected / exposed
    5 / 113 (4.42%)
    2 / 56 (3.57%)
    0 / 39 (0.00%)
    1 / 19 (5.26%)
    3 / 36 (8.33%)
    1 / 18 (5.56%)
    2 / 38 (5.26%)
    0 / 19 (0.00%)
         occurrences all number
    5
    2
    0
    1
    3
    1
    2
    0
    wound dehiscence
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    1 / 39 (2.56%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    2 / 113 (1.77%)
    2 / 56 (3.57%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    2 / 38 (5.26%)
    2 / 19 (10.53%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    2
    2
    Monoparesis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    1 / 39 (2.56%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    1 / 38 (2.63%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 113 (9.73%)
    3 / 56 (5.36%)
    1 / 39 (2.56%)
    0 / 19 (0.00%)
    5 / 36 (13.89%)
    1 / 18 (5.56%)
    5 / 38 (13.16%)
    2 / 19 (10.53%)
         occurrences all number
    13
    3
    1
    0
    5
    1
    7
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    1 / 38 (2.63%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    4 / 113 (3.54%)
    1 / 56 (1.79%)
    1 / 39 (2.56%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    3 / 38 (7.89%)
    1 / 19 (5.26%)
         occurrences all number
    4
    1
    1
    0
    0
    0
    3
    1
    Abdominal pain
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Colitis ulcerative
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    diarrhoea
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    pain in extremity
         subjects affected / exposed
    3 / 113 (2.65%)
    1 / 56 (1.79%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    2 / 38 (5.26%)
    1 / 19 (5.26%)
         occurrences all number
    3
    1
    0
    0
    1
    0
    2
    1
    Back pain
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    1 / 38 (2.63%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 56 (3.57%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 18 (5.56%)
    0 / 38 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    1
    Folliculitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 56 (0.00%)
    0 / 39 (0.00%)
    0 / 19 (0.00%)
    3 / 36 (8.33%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    0
    0
    3
    0
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 56 (0.00%)
    1 / 39 (2.56%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    0 / 38 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0

    More information

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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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