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    Clinical Trial Results:
    A Phase 2, Randomized, Active Comparator-Controlled, Open-Label, Adaptive Design Study to Assess the Safety and Efficacy of Intravenously-Administered SelK2 in Patients Undergoing Total Knee Arthroplasty

    Summary
    EudraCT number
    		 2018-003122-88
    Trial protocol
    		 LV   BG   LT   PL  
    Global end of trial date
    14 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Nov 2020
    First version publication date
    30 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SELK2-00005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03812328
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tetherex Pharmaceuticals Corporation
    Sponsor organisation address
    840 Research Parkway, Suite 516, Oklahoma City, United States, OK 73104
    Public contact
    Executive Director, Tetherex Pharmaceuticals Corporation, jstocker@tetherex.com
    Scientific contact
    Executive Director, Tetherex Pharmaceuticals Corporation, jstocker@tetherex.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
    14 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To investigate the efficacy of SelK2 as monotherapy for the prevention of total venous thromboembolism (VTE) in patients undergoing primary unilateral total knee arthroplasty (TKA). • To assess the incidence of bleeding events in patients administered SelK2 and undergoing primary unilateral TKA. • To assess the overall safety and tolerability of SelK2 in this patient population. The study protocol was designed with an adaptive group (SelK2 plus enoxaparin) that could be initiated if the Steering and Safety Committee determined that preliminary data suggested the potential for an additive effect in VTE reduction and that the combination did not pose an additional safety risk. The objectives of the adaptive group were to assess the efficacy and safety of SelK2 when given together with standard of care enoxaparin for the prevention of VTE in patients undergoing primary unilateral TKA.
    Protection of trial subjects
    The study was conducted in accordance with the protocol, the ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation Good Clinical Practice Guidelines, and applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Feb 2019
    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
    Bulgaria: 8
    Country: Number of subjects enrolled
    Latvia: 72
    Country: Number of subjects enrolled
    Lithuania: 44
    Country: Number of subjects enrolled
    Poland: 22
    Country: Number of subjects enrolled
    Ukraine: 61
    Worldwide total number of subjects
    207
    EEA total number of subjects
    146
    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)
    78
    From 65 to 84 years
    129
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This Phase 2, multicenter, randomized, active comparator-controlled, open-label, adaptive design study assessed efficacy and safety of intravenous (IV) administration of SelK2 in patients undergoing TKA.

    Pre-assignment
    Screening details
    		 The study consisted of up to a 30-day Screening Phase, an 11-day (± 2 days) Treatment Phase and a 45-day Follow-up Phase. Patients were initially randomized 1:1 to SelK2 alone or enoxaparin. When the adaptive group was activated, the SelK2 alone group was discontinued. Patients were then randomized 2:1 to SelK2 plus enoxaparin or enoxaparin only.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SelK2
    Arm description
    		 On Day 1, patients received a single dose of SelK2 at 7.5 milligrams/kilogram (mg/kg), IV, administered 12 to 24 hours prior to TKA. On Day 2, TKA surgery was performed. Venography of the operated leg was performed on Day 11 (± 2 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    SelK2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    SelK2 was administered as an IV infusion over 30 minutes.

    Arm title
    		 SelK2 plus Enoxaparin (adaptive group)
    Arm description
    		 On Day 1, patients received a single dose of SelK2 at 7.5 mg/kg, IV, administered 12 to 24 hours prior to TKA. On Day 2, TKA surgery was performed and patients received enoxaparin at 40 mg, subcutaneous (SC), administered 12 hours post-TKA. Patients then continued to receive enoxaparin at 40 mg, SC, once daily (QD) on Days 3 to 11. Venography of the operated leg was performed on Day 11 (± 2 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    SelK2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    SelK2 was administered as an IV infusion over 30 minutes.

    Investigational medicinal product name
    Enoxaparin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Commercially available enoxaparin (40 mg in 0.4 milliliter [mL] water in pre-filled disposable syringes for SC administration) was provided to the study site pharmacies for use in this study, in accordance with local regulatory requirements.

    Arm title
    		 Enoxaparin
    Arm description
    		 On Day 1, patients received an optional dose of enoxaparin at 40 mg, SC, administered at least 12 hours pre-TKA. On Day 2, TKA surgery was performed and patients received enoxaparin at 40 mg, SC, administered 12 hours post-TKA. Patients then continued to receive enoxaparin at 40 mg, SC, QD on Days 3 to 11. Venography of the operated leg was performed on Day 11 (± 2 days).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Enoxaparin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Commercially available enoxaparin (40 mg in 0.4 mL water in pre-filled disposable syringes for SC administration) was provided to the study site pharmacies for use in this study, in accordance with local regulatory requirements.

    Number of subjects in period 1
    		SelK2 SelK2 plus Enoxaparin (adaptive group) Enoxaparin
    Started
    55
    63
    89
    Completed
    55
    60
    88
    Not completed
    0
    3
    1
         Consent withdrawn by subject
    -
    3
    -
         Did not receive treatment because surgery delayed
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SelK2
    Reporting group description
    		 On Day 1, patients received a single dose of SelK2 at 7.5 milligrams/kilogram (mg/kg), IV, administered 12 to 24 hours prior to TKA. On Day 2, TKA surgery was performed. Venography of the operated leg was performed on Day 11 (± 2 days).

    Reporting group title
    SelK2 plus Enoxaparin (adaptive group)
    Reporting group description
    		 On Day 1, patients received a single dose of SelK2 at 7.5 mg/kg, IV, administered 12 to 24 hours prior to TKA. On Day 2, TKA surgery was performed and patients received enoxaparin at 40 mg, subcutaneous (SC), administered 12 hours post-TKA. Patients then continued to receive enoxaparin at 40 mg, SC, once daily (QD) on Days 3 to 11. Venography of the operated leg was performed on Day 11 (± 2 days).

    Reporting group title
    Enoxaparin
    Reporting group description
    		 On Day 1, patients received an optional dose of enoxaparin at 40 mg, SC, administered at least 12 hours pre-TKA. On Day 2, TKA surgery was performed and patients received enoxaparin at 40 mg, SC, administered 12 hours post-TKA. Patients then continued to receive enoxaparin at 40 mg, SC, QD on Days 3 to 11. Venography of the operated leg was performed on Day 11 (± 2 days).

    Reporting group values
    		 SelK2 SelK2 plus Enoxaparin (adaptive group) Enoxaparin Total
    Number of subjects
    		 55 63 89 207
    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)
    		 66.3 ± 6.35 66.3 ± 7.54 65.6 ± 7.30 -
    Gender categorical
    Units: Subjects
        Female
    		 42 52 68 162
        Male
    		 13 11 21 45

    End points

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    End points reporting groups
    Reporting group title
    SelK2
    Reporting group description
    		 On Day 1, patients received a single dose of SelK2 at 7.5 milligrams/kilogram (mg/kg), IV, administered 12 to 24 hours prior to TKA. On Day 2, TKA surgery was performed. Venography of the operated leg was performed on Day 11 (± 2 days).

    Reporting group title
    SelK2 plus Enoxaparin (adaptive group)
    Reporting group description
    		 On Day 1, patients received a single dose of SelK2 at 7.5 mg/kg, IV, administered 12 to 24 hours prior to TKA. On Day 2, TKA surgery was performed and patients received enoxaparin at 40 mg, subcutaneous (SC), administered 12 hours post-TKA. Patients then continued to receive enoxaparin at 40 mg, SC, once daily (QD) on Days 3 to 11. Venography of the operated leg was performed on Day 11 (± 2 days).

    Reporting group title
    Enoxaparin
    Reporting group description
    		 On Day 1, patients received an optional dose of enoxaparin at 40 mg, SC, administered at least 12 hours pre-TKA. On Day 2, TKA surgery was performed and patients received enoxaparin at 40 mg, SC, administered 12 hours post-TKA. Patients then continued to receive enoxaparin at 40 mg, SC, QD on Days 3 to 11. Venography of the operated leg was performed on Day 11 (± 2 days).

    Primary: Incidence of Total VTE Through Venography Day (Day 11)

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    End point title
    		 Incidence of Total VTE Through Venography Day (Day 11)
    End point description
    The primary efficacy endpoint was incidence of total VTE (reported as a percentage of patients) during the Treatment Phase up to venography day (Day 11 ± 2 days). Incidence of total VTE consisted of a composite of: • Asymptomatic deep vein thrombosis (DVT) detected by mandatory unilateral venography of the operated leg; • Confirmed symptomatic DVT of the leg(s); • Confirmed symptomatic pulmonary embolism (PE); or • Unexplained death for which PE could not be ruled out. VTE incidence = presence of any 1 of the 4 composite components. All efficacy endpoint data was adjudicated by the blinded Central Independent Adjudication Committee (CIAC). Analysis was performed on the modified intent-to-treat (mITT) population consisting of all randomized patients who also had a successful venogram or symptomatic VTE event, which allowed for assessment of the primary efficacy outcome.
    End point type
    Primary
    End point timeframe
    Day 1 up to Day 11 (venography day)
    End point values
    		 SelK2 SelK2 plus Enoxaparin (adaptive group) Enoxaparin
    Number of subjects analysed
    48
    61
    84
    Units: percentage of patients
        number (not applicable)
    39.6
    47.5
    20.2
    Statistical analysis title
    		 Comparison of SelK2 vs Enoxaparin
    Statistical analysis description
    Analysis was performed using the Farrington-Manning test with the non-inferiority margin of 15%. The 1-sided upper 90% confidence interval (CI) of the difference between SelK2 alone and enoxaparin alone was calculated and non-inferiority concluded if the upper limit of the 90% CI was ≤ 15%.
    Comparison groups
    SelK2 v Enoxaparin
    Number of subjects included in analysis
    132
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7
    Method
    		 Farrington-Manning test
    Parameter type
    		 Treatment Difference (%)
    Point estimate
    19.3
    Confidence interval
         level
    		 90%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 32.2
    Statistical analysis title
    		 Comparison of SelK2 plus Enoxaparin vs Enoxaparin
    Statistical analysis description
    Analysis was performed using the Farrington-Manning test with the non-inferiority margin of 15%. The 1-sided upper 90% CI of the difference between SelK2 plus enoxaparin (adaptive group) and enoxaparin alone was calculated and non-inferiority concluded if the upper limit of the 90% CI was ≤ 15%.
    Comparison groups
    SelK2 plus Enoxaparin (adaptive group) v Enoxaparin
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.942
    Method
    		 Farrington-Manning test
    Parameter type
    		 Treatment Difference (%)
    Point estimate
    27.3
    Confidence interval
         level
    		 90%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 40

    Secondary: Incidence of Total VTE Through Day 57

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    End point title
    		 Incidence of Total VTE Through Day 57
    End point description
    The incidence of total VTE (reported as a percentage of patients) was assessed during the 11-day (± 2 days) Treatment Phase and 45-day Follow-up Phase up to Day 57. Incidence of total VTE consisted of a composite of: • Asymptomatic DVT detected by mandatory unilateral venography of the operated leg; • Confirmed symptomatic DVT of the leg(s); • Confirmed symptomatic PE; or • Unexplained death for which PE could not be ruled out. VTE incidence = presence of any 1 of the 4 composite components. All efficacy endpoint data was adjudicated by the blinded CIAC. Analysis was performed on the mITT population consisting of all randomized patients who also had a successful venogram or symptomatic VTE event, which allowed for assessment of the primary efficacy outcome.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 57
    End point values
    		 SelK2 SelK2 plus Enoxaparin (adaptive group) Enoxaparin
    Number of subjects analysed
    48
    61
    84
    Units: percentage of patients
        number (not applicable)
    39.6
    47.5
    20.2
    No statistical analyses for this end point

    Secondary: Incidences of Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Unexplained Deaths Through Venography Day (Day 11)

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    End point title
    		 Incidences of Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Unexplained Deaths Through Venography Day (Day 11)
    End point description
    The incidences of asymptomatic DVT, symptomatic DVT, symptomatic PE, and unexplained deaths (ie, individual composite components of the primary efficacy endpoint and reported as percentages of patients) were assessed during the Treatment Phase up to venography day (Day 11 ± 2 days). All efficacy endpoint data was adjudicated by the blinded CIAC. Analysis was performed on the mITT population consisting of all randomized patients who also had a successful venogram or symptomatic VTE event, which allowed for assessment of the primary efficacy outcome.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 11 (venography day)
    End point values
    		 SelK2 SelK2 plus Enoxaparin (adaptive group) Enoxaparin
    Number of subjects analysed
    48
    61
    84
    Units: percentage of patients
    number (not applicable)
        Asymptomatic DVT
    35.4
    45.9
    20.2
        Symptomatic DVT
    2.1
    0.0
    0.0
        Symptomatic PE
    2.1
    1.6
    0.0
        Unexplained Death
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Incidences of Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Unexplained Deaths Through Day 57

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    End point title
    		 Incidences of Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Unexplained Deaths Through Day 57
    End point description
    The incidences of asymptomatic DVT, symptomatic DVT, symptomatic PE, and unexplained deaths (ie, individual composite components of the primary efficacy endpoint and reported as percentages of patients) were assessed during the 11-day (± 2 days) Treatment Phase and 45-day Follow-up Phase up to Day 57. All efficacy endpoint data was adjudicated by the blinded CIAC. Analysis was performed on the mITT population consisting of all randomized patients who also had a successful venogram or symptomatic VTE event, which allowed for assessment of the primary efficacy outcome.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 57
    End point values
    		 SelK2 SelK2 plus Enoxaparin (adaptive group) Enoxaparin
    Number of subjects analysed
    48
    61
    84
    Units: percentage of patients
    number (not applicable)
        Asymptomatic DVT
    35.4
    45.9
    20.2
        Symptomatic DVT
    2.1
    0.0
    0.0
        Symptomatic PE
    2.1
    1.6
    0.0
        Unexplained Death
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Number of Patients with Treatment-emergent Bleeding Events

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    End point title
    		 Number of Patients with Treatment-emergent Bleeding Events
    End point description
    All suspected bleeding events were reviewed by the CIAC in a blinded fashion and were adjudicated for categorization as Major Bleeding (MB), Clinically Relevant Non-Major Bleeding (CRNMB), Minor Bleeding, or combination of MB and CRNMB. The number of patients in each of the indicated categories is reported. Analysis was performed on the safety population consisting of all patients who received at least 1 dose of study drug, analyzed by actual treatment received.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 57
    End point values
    		 SelK2 SelK2 plus Enoxaparin (adaptive group) Enoxaparin
    Number of subjects analysed
    55
    63
    88
    Units: number of patients
        Any Bleeding Event
    3
    1
    0
        MB Event
    0
    0
    0
        CRNMB Event
    2
    1
    0
        Minor Bleeding Event
    2
    0
    0
        Combination of MB and CRNMB Events
    2
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Day 57.
    Adverse event reporting additional description
    Treatment-emergent adverse events were defined as adverse events that started or worsened in severity on or after the randomization day (Day 1) through completion of the final Follow-up Phase visit (Day 57). The safety population consisted of all patients who received at least 1 dose of study drug, analyzed by actual treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    SelK2
    Reporting group description
    		 On Day 1, patients received a single dose of SelK2 at 7.5 mg/kg, IV, administered 12 to 24 hours prior to TKA. On Day 2, TKA surgery was performed. Venography of the operated leg was performed on Day 11 (± 2 days).

    Reporting group title
    SelK2 plus Enoxaparin (adaptive group)
    Reporting group description
    		 On Day 1, patients received a single dose of SelK2 at 7.5 mg/kg, IV, administered 12 to 24 hours prior to TKA. On Day 2, TKA surgery was performed and patients received enoxaparin at 40 mg, SC, administered 12 hours post-TKA. Patients then continued to receive enoxaparin at 40 mg, SC, QD on Days 3 to 11. Venography of the operated leg was performed on Day 11 (± 2 days).

    Reporting group title
    Enoxaparin
    Reporting group description
    		 On Day 1, patients received an optional dose of enoxaparin at 40 mg, SC, administered at least 12 hours pre-TKA. On Day 2, TKA surgery was performed and patients received enoxaparin at 40 mg, SC, administered 12 hours post-TKA. Patients then continued to receive enoxaparin at 40 mg, SC, QD on Days 3 to 11. Venography of the operated leg was performed on Day 11 (± 2 days).

    Serious adverse events
    		 SelK2 SelK2 plus Enoxaparin (adaptive group) Enoxaparin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 55 (3.64%)
    3 / 63 (4.76%)
    2 / 88 (2.27%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 63 (1.59%)
    0 / 88 (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 disorders
    Myocardial ischaemia
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 63 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 63 (0.00%)
    0 / 88 (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
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 63 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 63 (1.59%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Post procedural infection
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 63 (1.59%)
    0 / 88 (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
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 SelK2 SelK2 plus Enoxaparin (adaptive group) Enoxaparin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 55 (16.36%)
    6 / 63 (9.52%)
    10 / 88 (11.36%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 63 (1.59%)
    2 / 88 (2.27%)
         occurrences all number
    0
    1
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 63 (3.17%)
    1 / 88 (1.14%)
         occurrences all number
    0
    2
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 55 (5.45%)
    4 / 63 (6.35%)
    6 / 88 (6.82%)
         occurrences all number
    3
    4
    6
    Injury, poisoning and procedural complications
    Procedural haemorrhage
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 63 (0.00%)
    1 / 88 (1.14%)
         occurrences all number
    3
    0
    1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 63 (0.00%)
    2 / 88 (2.27%)
         occurrences all number
    2
    0
    2
    Hypertension
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 63 (0.00%)
    1 / 88 (1.14%)
         occurrences all number
    2
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 63 (1.59%)
    0 / 88 (0.00%)
         occurrences all number
    2
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 May 2019
    • Updated adaptive design to initiate a prespecified adaptive group of the study and added text to reflect the discontinuation of the SelK2 alone group of the study. • Added clarification on specifics of dosing of SelK2 plus enoxaparin group (newly added adaptive group). • Modified the randomization procedures to accommodate the activation of the adaptive group and the discontinuation of the SelK2 alone group. • Added text to allow sites flexibility in the method of measuring body temperature and added text to clarify that the serum pregnancy test was only required for women of childbearing potential. • Added text to clarify that in the adaptive group, SelK2 should be administered the night prior to surgery and that enoxaparin should be administered approximately 12 hours after surgery, while the option to dose enoxaparin 12 hours prior to surgery was eliminated. • Added text to clarify that the planned primary and secondary analyses included the adaptive group.

    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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