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    Clinical Trial Results:
    A Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated (FS VH S/D 500 s-apr) Compared to DuraSeal Dural Sealant as an Adjunct to Sutured Dural Repair in Cranial Surgery

    Summary
    EudraCT number
    		 2015-005535-40
    Trial protocol
    		 DE   CZ   ES   PL  
    Global end of trial date
    22 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Sep 2019
    First version publication date
    06 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3599-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02891070
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Baxter Healthcare Corporation
    Sponsor organisation address
    1 Baxter Pkwy, Deerfield, United States, 60015
    Public contact
    Baxter Clinical Trials Disclosure Call Center, Baxter Healthcare Corporation, 224 948-7359, Global_CORP_ClinicalTrialsDisclosure@baxter.com
    Scientific contact
    Baxter Clinical Trials Disclosure Call Center, Baxter Healthcare Corporation, 224 948-7359, 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
    11 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of FS VH S/D 500 s-apr compared to DuraSeal Dural Sealant as an adjunct to sutured dural closure.
    Protection of trial subjects
    In case of a continuous CSF leak in spite of treatment (i.e., treatment failure), rescue therapy using standard of care was permitted at the surgeon’s choice (including use of other sealants, dural patches, etc. [excluding further use of the IP or control in either of the 2 groups]).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Oct 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 36
    Country: Number of subjects enrolled
    Spain: 67
    Country: Number of subjects enrolled
    Czech Republic: 92
    Country: Number of subjects enrolled
    Germany: 29
    Worldwide total number of subjects
    224
    EEA total number of subjects
    188
    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)
    178
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 It was expected to screen approximately 476 patients in order to randomize approximately 224 patients (with a minimal number of 56 PF procedures) and have 202 evaluable patients.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tisseel
    Arm description
    		 Investigational Product: FS VH S/D 500 s-apr (Tisseel) frozen 4 mL syringe
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tisseel
    Investigational medicinal product code
    FS VH S/D 500 s-apr
    Other name
    Pharmaceutical forms
    Solution for sealant
    Routes of administration
    Epilesional use
    Dosage and administration details
    Tisseel (FS VH S/D 500 s-apr), single use treatment, frozen 4 mL syringe, was administered intra-operatively with sutures during dural closure. Product was applied with cannula by dripping in a thin and continuous layer with a 5 mm overlap on each side of the sutured line, ensuring that all suture holes were covered.

    Arm title
    		 DuraSeal
    Arm description
    		 Control: DuraSeal 5 mL syringe
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DuraSeal
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for sealant
    Routes of administration
    Epilesional use
    Dosage and administration details
    DuraSeal Dural Sealant, single use treatment, was administered intra-operatively with sutures during dural closure. The product was applied with the DuraSeal System Applicator by spraying a thin (1 – 2 mm) coating, ensuring that all suture holes were covered.

    Number of subjects in period 1
    		Tisseel DuraSeal
    Started
    110
    114
    Completed
    100
    106
    Not completed
    10
    8
         Adverse event, serious fatal
    3
    -
         Consent withdrawn by subject
    1
    2
         Physician decision
    -
    1
         Adverse event, non-fatal
    1
    -
         Unknown
    1
    -
         Lost to follow-up
    4
    4
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tisseel
    Reporting group description
    		 Investigational Product: FS VH S/D 500 s-apr (Tisseel) frozen 4 mL syringe

    Reporting group title
    DuraSeal
    Reporting group description
    		 Control: DuraSeal 5 mL syringe

    Reporting group values
    		 Tisseel DuraSeal Total
    Number of subjects
    		 110 114 224
    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)
    		 51.8 ± 14.24 51.3 ± 14.85 -
    Gender categorical
    Units: Subjects
        Female
    		 66 65 131
        Male
    		 44 49 93
    Race
    Units: Subjects
        American Indian or Alaskan Native
    		 0 0 0
        Asian
    		 0 0 0
        Black or African American
    		 2 2 4
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        White
    		 97 101 198
        Other
    		 11 11 22

    End points

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    End points reporting groups
    Reporting group title
    Tisseel
    Reporting group description
    		 Investigational Product: FS VH S/D 500 s-apr (Tisseel) frozen 4 mL syringe

    Reporting group title
    DuraSeal
    Reporting group description
    		 Control: DuraSeal 5 mL syringe

    Subject analysis set title
    Tisseel (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Set (PPS) - The PPS was defined as a subset of the FAS. Patients with any major deviation that may have impacted the primary efficacy parameter were excluded from the PPS.

    Subject analysis set title
    DuraSeal (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Set (PPS) - The PPS was defined as a subset of the FAS. Patients with any major deviation that may have impacted the primary efficacy parameter were excluded from the PPS.

    Subject analysis set title
    Tisseel (SAS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set (SAS) - Consisted of all patients who were treated with IP/Control. Patients were analyzed as treated.

    Subject analysis set title
    DuraSeal (SAS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set (SAS) - Consisted of all patients who were treated with IP/Control. Patients were analyzed as treated.

    Primary: Number of Participants with No CSF Leaks During and after Surgery

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    End point title
    		 Number of Participants with No CSF Leaks During and after Surgery
    End point description
    Participants who have no intra-operative CSF leak from dural repair after up to two applications during Valsalva maneuver (25 cm H2O for up to 5 - 10 seconds), or post-operative CSF leak within 30 (+3) days post-operatively. The Valsalva maneuver was performed by the anaesthesiologist to increase the intra-thoracic pressure (e.g., by increasing the positive end-expiratory pressure or by giving a large tidal volume and holding the inflating pressure) to approximately 25 cm H2O, constantly for up to 5 - 10 seconds to transiently elevate the intracranial pressure and test for any CSF leaks. The suture line was to be watertight after up to two product/control applications and Valsalva maneuvers.
    End point type
    Primary
    End point timeframe
    Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative
    End point values
    		 Tisseel (PPS) DuraSeal (PPS)
    Number of subjects analysed
    89
    95
    Units: Participants
    76
    87
    Statistical analysis title
    		 Stats
    Comparison groups
    Tisseel (PPS) v DuraSeal (PPS)
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Mean difference (net)
    Point estimate
    -9.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.11
         upper limit
    		 2.54
    Notes
    [1] - To demonstrate non-inferiority of Tisseel to DuraSeal for the primary endpoint, the lower limit of the 95% CI (based on normal approximation) for the difference in average predicted proportions had to be greater than -10%.

    Secondary: Number of Participants with No Intra-Operative CSF Leaks following final Valsalva maneuver

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    End point title
    		 Number of Participants with No Intra-Operative CSF Leaks following final Valsalva maneuver
    End point description
    Assessment of whether the suture line was not watertight causing CSF leaks after up to two product/control applications and Valsalva maneuvers.
    End point type
    Secondary
    End point timeframe
    Day 0 (Intra-operative)
    End point values
    		 Tisseel (PPS) DuraSeal (PPS)
    Number of subjects analysed
    89
    95
    Units: Participants
    89
    95
    No statistical analyses for this end point

    Secondary: Number of Participants with CSF Leaks within 30 (+3) days post-operatively

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    End point title
    		 Number of Participants with CSF Leaks within 30 (+3) days post-operatively
    End point description
    Cerebrospinal fluid leak was defined as any overt flow, seepage, weeping, or sweating of CSF through the dura suture line, regardless of volume. All post-operative CSF leaks were primarily diagnosed based on a detailed history and physical examination, including neurological examination. Although not standard of care post-operatively, imaging tests such as computed tomography/magnetic resonance imaging (MRI) were considered if there was a high clinical suspicion of a CSF leak.
    End point type
    Secondary
    End point timeframe
    Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative
    End point values
    		 Tisseel (PPS) DuraSeal (PPS)
    Number of subjects analysed
    89
    95
    Units: Participants
    8
    2
    Statistical analysis title
    		 Stats
    Comparison groups
    DuraSeal (PPS) v Tisseel (PPS)
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Mean difference (net)
    Point estimate
    -9.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.11
         upper limit
    		 2.54
    Notes
    [2] - To demonstrate non-inferiority of Tisseel to DuraSeal for the primary endpoint, the lower limit of the 95% CI (based on normal approximation) for the difference in average predicted proportions had to be greater than -10%.

    Secondary: Duration in Surgery (minutes)

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    End point title
    		 Duration in Surgery (minutes)
    End point description
    Patients undergoing elective cranial surgery for the treatment of a pathological condition (e.g., benign/malignant tumours, vascular malformations, or Chiari type 1 malformations) specifically located in the posterior fossa (PF) or supratentorial (ST) regions.
    End point type
    Secondary
    End point timeframe
    Day 0 (intra-operatively)
    End point values
    		 Tisseel (PPS) DuraSeal (PPS)
    Number of subjects analysed
    89
    95
    Units: Minutes
        arithmetic mean (standard deviation)
    241.8 ± 100.80
    210.3 ± 90.49
    Statistical analysis title
    		 Stats
    Comparison groups
    Tisseel (PPS) v DuraSeal (PPS)
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0241
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Time from Dural Closure (application of IP) until End of Surgery

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    End point title
    		 Time from Dural Closure (application of IP) until End of Surgery
    End point description
    Suture closure techniques include continuous simple, continuous locked, interrupted.
    End point type
    Secondary
    End point timeframe
    Day 0 (Intra-operatively)
    End point values
    		 Tisseel (PPS) DuraSeal (PPS)
    Number of subjects analysed
    89
    95
    Units: MInutes
        arithmetic mean (standard deviation)
    34 ± 16.13
    31.4 ± 17.07
    Statistical analysis title
    		 Stats
    Comparison groups
    Tisseel (PPS) v DuraSeal (PPS)
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1015
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Length of Stay in Hospital (days)

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    End point title
    		 Length of Stay in Hospital (days)
    End point description
    Days in hospital calculation is Day 0 - Discharge.
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 60 (Study Completion)
    End point values
    		 Tisseel (PPS) DuraSeal (PPS)
    Number of subjects analysed
    89
    95
    Units: Days
        arithmetic mean (standard deviation)
    13.5 ± 15.57
    12.6 ± 8.67
    Statistical analysis title
    		 Stats
    Comparison groups
    Tisseel (PPS) v DuraSeal (PPS)
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9943
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Post-hoc: Number of Surgical Site Infections (SSI)

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    End point title
    		 Number of Surgical Site Infections (SSI)
    End point description
    Surgical site infections were evaluated by the surgeon or designated physician according to United States (US) National Healthcare Safety Network (NHSN) criteria as specified in the study protocol.
    End point type
    Post-hoc
    End point timeframe
    Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative
    End point values
    		 Tisseel (SAS) DuraSeal (SAS)
    Number of subjects analysed
    110
    114
    Units: SSI
        number (not applicable)
    1
    4
    Statistical analysis title
    		 Stats
    Comparison groups
    Tisseel (SAS) v DuraSeal (SAS)
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Regression, Logistic
    Parameter type
    		 Mean difference (net)
    Point estimate
    -5.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.6
         upper limit
    		 3.39

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day -30 (Pre-operative) to Day 60 (+/- 3 days)
    Adverse event reporting additional description
    Treatment-Emergent Adverse Events (TEAE) were reported for both Adverse Event (AE) and Serious Adverse Events (SAE). TEAE's are events that began or worsen in severity after the first administration of treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Tisseel
    Reporting group description
    		 -

    Reporting group title
    DuraSeal
    Reporting group description
    		 -

    Serious adverse events
    		 Tisseel DuraSeal
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 110 (20.00%)
    17 / 114 (14.91%)
         number of deaths (all causes)
    3
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Brain Contusion
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural Haematoma
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocephalus
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomeningocele
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Dehiscence
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 114 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Haematoma
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Arrest
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Brain Oedema
         subjects affected / exposed
    1 / 110 (0.91%)
    2 / 114 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal Fluid Leakage
         subjects affected / exposed
    7 / 110 (6.36%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    4 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    3 / 110 (2.73%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic Intracranial Hypertension
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensorimotor Disorder
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior Sagittal Sinus Thrombosis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic Infarction
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Distress
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal Insufficiency
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Brain Abscess
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 114 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Empyema
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epidural Empyema
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 114 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Infection
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 114 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tisseel DuraSeal
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 110 (41.82%)
    46 / 114 (40.35%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 110 (4.55%)
    6 / 114 (5.26%)
         occurrences all number
    5
    6
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 110 (5.45%)
    3 / 114 (2.63%)
         occurrences all number
    8
    4
    Headache
         subjects affected / exposed
    20 / 110 (18.18%)
    21 / 114 (18.42%)
         occurrences all number
    25
    25
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    15 / 110 (13.64%)
    15 / 114 (13.16%)
         occurrences all number
    15
    16
    Pyrexia
         subjects affected / exposed
    3 / 110 (2.73%)
    7 / 114 (6.14%)
         occurrences all number
    6
    7
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    8 / 110 (7.27%)
    5 / 114 (4.39%)
         occurrences all number
    9
    5
    Nausea
         subjects affected / exposed
    10 / 110 (9.09%)
    14 / 114 (12.28%)
         occurrences all number
    12
    16
    Vomiting
         subjects affected / exposed
    10 / 110 (9.09%)
    14 / 114 (12.28%)
         occurrences all number
    15
    17

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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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