Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two‐arm, Double Blind Study to assess Efficacy and Safety of D‐PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated control arm, in prevention of post abdominal surgery incisional infection.

    Summary
    EudraCT number
    		 2020-002325-28
    Trial protocol
    		 BG   CZ   HR   HU   SK   PL   RO  
    Global end of trial date
    08 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Sep 2023
    First version publication date
    29 Sep 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D-PLEX311
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04233424
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    PolyPid Ltd
    Sponsor organisation address
    Hasivim 18, Petach Tikva, Israel,
    Public contact
    Clinical Operations Manager, CTG Bulgaria EOOD, 00359 2462 72 50, simeon.georgiev@ctgcro.com
    Scientific contact
    Clinical Operations Manager, CTG Bulgaria EOOD, 00359 2462 72 50, simeon.georgiev@ctgcro.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
    01 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the anti‐infective efficacy of D‐PLEX administered concomitantly with the Standard of Care (SoC) over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and/or deep infection in the target incision, compared to the SoC treated control arm and to assess the safety of D‐PLEX administered concomitantly with the Standard of Care (SoC).
    Protection of trial subjects
    Data was collected using eCRFs that are specifically designed for this study. The data collected on the eCRFs was captured in a clinical data management system (CDMS) that meets the technical requirements described in 21 CFR Part 11 and EU regulations. The CDMS was fully validated to ensure that it meets the scientific, regulatory, and logistical requirements of the study before it is used to capture data from this study. Before using the CDMS, all users received training on the system and study-specific training. After they are trained, users were provided with individual system access rights. Data was collected at the investigational center by appropriately designated and trained personnel, and eCRFs must be completed for each screened subject according to their source documents. Subject identity was not discernible from the data provided on the eCRF.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jun 2020
    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
    Israel: 140
    Country: Number of subjects enrolled
    United States: 37
    Country: Number of subjects enrolled
    Moldova, Republic of: 177
    Country: Number of subjects enrolled
    Romania: 168
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Slovakia: 14
    Country: Number of subjects enrolled
    Croatia: 40
    Country: Number of subjects enrolled
    Bulgaria: 92
    Country: Number of subjects enrolled
    Czechia: 132
    Country: Number of subjects enrolled
    Hungary: 160
    Worldwide total number of subjects
    977
    EEA total number of subjects
    623
    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)
    453
    From 65 to 84 years
    496
    85 years and over
    28

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subject recruitment were conducted in general surgery departments at sites in US, Europe & Israel.

    Pre-assignment
    Screening details
    		 The study population includes male and female, 18 years old and above at screening, undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is > 10 cm (target incision).

    Pre-assignment period milestones
    Number of subjects started
    		 1038 [1]
    Number of subjects completed
    		 977

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Failure to meet eligibility criteria: 37
    Reason: Number of subjects
    		 Not eligiblt to the study: 13
    Reason: Number of subjects
    		 Consent withdrawn by subject: 10
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1038 subjects were screened, 977 subjects were randomized to the study that equal to worldwild number of enrolled subjects.
    Period 1
    Period 1 title
    Baseline/Screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    The sponsor, the subjects, outcomes assessor and all staff involved in the collection and recording of the clinical and laboratory data, based on which the independent adjudication committee will perform their assessment, will be blinded to treatment assignment. In addition, all aspects of data management and clean-up will be done in blinded datasets.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Investigational (D-PLEX)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    D-PLEX
    Investigational medicinal product code
    Other name
    Doxycycline new formulation
    Pharmaceutical forms
    Powder for implantation paste
    Routes of administration
    Local use
    Dosage and administration details
    D-PLEX dose is individualized, pending length of the abdominal target incision, 2-3 vials (5g each, a total max of 15g) in a single application. Application will be done at the time of initial closure of the abdominal wall target incision. Following closure of the fascia, D-PLEX reconstituted paste will be applied on the fascia suture line, followed by soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis). D-PLEX will not be applied on top of the skin (suture line).

    Arm title
    		 Control (SoC)
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Investigational (D-PLEX) Control (SoC)
    Started
    488
    489
    Completed
    488
    489
    Period 2
    Period 2 title
    30 Days post-surgery
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Assessor, Subject
    Blinding implementation details
    The sponsor, the subjects, outcomes assessor and all staff involved in the collection and recording of the clinical and laboratory data, based on which the independent adjudication committee will perform their assessment, will be blinded to treatment assignment. In addition, all aspects of data management and clean-up will be done in blinded datasets. The study site personnel, who perform the index surgery or re-intervention procedure (OR staff), will be trained not to disclose the treatment arm

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Investigational (D-PLEX)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    D-PLEX
    Investigational medicinal product code
    Other name
    Doxycycline new formulation
    Pharmaceutical forms
    Powder for implantation paste
    Routes of administration
    Local use
    Dosage and administration details
    D-PLEX dose is individualized, pending length of the abdominal target incision, 2-3 vials (5g each, a total max of 15g) in a single application. Application will be done at the time of initial closure of the abdominal wall target incision. Following closure of the fascia, D-PLEX reconstituted paste will be applied on the fascia suture line, followed by soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis). D-PLEX will not be applied on top of the skin (suture line).

    Arm title
    		 Control (SoC)
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Investigational (D-PLEX) Control (SoC)
    Started
    488
    489
    Completed
    485
    489
    Not completed
    3
    0
         Protocol deviation
    3
    -
    Period 3
    Period 3 title
    60 Days post-surgery
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    The sponsor, the subjects, outcomes assessor and all staff involved in the collection and recording of the clinical and laboratory data, based on which the independent adjudication committee will perform their assessment, will be blinded to treatment assignment. In addition, all aspects of data management and clean-up will be done in blinded datasets.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Investigational (D-PLEX)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    D-PLEX
    Investigational medicinal product code
    Other name
    Doxycycline new formulation
    Pharmaceutical forms
    Powder for implantation paste
    Routes of administration
    Local use
    Dosage and administration details
    D-PLEX dose is individualized, pending length of the abdominal target incision, 2-3 vials (5g each, a total max of 15g) in a single application. Application will be done at the time of initial closure of the abdominal wall target incision. Following closure of the fascia, D-PLEX reconstituted paste will be applied on the fascia suture line, followed by soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis). D-PLEX will not be applied on top of the skin (suture line).

    Arm title
    		 Control (SoC)
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Investigational (D-PLEX) Control (SoC)
    Started
    485
    489
    Completed
    461
    458
    Not completed
    24
    31
         Adverse event, serious fatal
    15
    16
         Consent withdrawn by subject
    2
    8
         Physician decision
    1
    3
         Subject refuse to visit site
    2
    -
         Lost to follow-up
    1
    3
         Protocol deviation
    3
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Investigational (D-PLEX)
    Reporting group description
    		 -

    Reporting group title
    Control (SoC)
    Reporting group description
    		 -

    Reporting group values
    		 Investigational (D-PLEX) Control (SoC) Total
    Number of subjects
    		 488 489 977
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.7 ( 12.75 ) 63.7 ( 13.27 ) -
    Gender categorical
    Units: Subjects
        Female
    		 197 198 395
        Male
    		 291 291 582
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    this population included all abdominally-incision randomized subjects. In this population, treatment was assigned based upon the treatment to which subjects were randomized regardless of which treatment they actually received.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This population included all subjects randomized and treated with D-PLEX or SoC. In this population, treatment was assigned based upon the treatment subjects actually received regardless of the treatment to which they were randomized.

    Subject analysis set title
    Incision >20cm (D-PLEX arm)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The analysis set was include all subjects who have been randomized to receive D-PLEX plus SoC with target abdominal incision length >20 cm. In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received.

    Subject analysis set title
    Incision >20cm (SoC)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The analysis set was include all subjects who have been randomized to receive SoC alone with target abdominal incision length >20 cm. In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received.

    Subject analysis sets values
    		 ITT Safety Incision >20cm (D-PLEX arm) Incision >20cm (SoC)
    Number of subjects
    974
    976
    212
    211
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.2 ( 13.02 )
    64.2 ( 13.03 )
    64.5 ( 11.15 )
    64.7 ( 12.17 )
    Gender categorical
    Units: Subjects
        Female
    395
    394
    70
    78
        Male
    579
    582
    142
    133

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Investigational (D-PLEX)
    Reporting group description
    		 -

    Reporting group title
    Control (SoC)
    Reporting group description
    		 -
    Reporting group title
    Investigational (D-PLEX)
    Reporting group description
    		 -

    Reporting group title
    Control (SoC)
    Reporting group description
    		 -
    Reporting group title
    Investigational (D-PLEX)
    Reporting group description
    		 -

    Reporting group title
    Control (SoC)
    Reporting group description
    		 -

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    this population included all abdominally-incision randomized subjects. In this population, treatment was assigned based upon the treatment to which subjects were randomized regardless of which treatment they actually received.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    This population included all subjects randomized and treated with D-PLEX or SoC. In this population, treatment was assigned based upon the treatment subjects actually received regardless of the treatment to which they were randomized.

    Subject analysis set title
    Incision >20cm (D-PLEX arm)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The analysis set was include all subjects who have been randomized to receive D-PLEX plus SoC with target abdominal incision length >20 cm. In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received.

    Subject analysis set title
    Incision >20cm (SoC)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The analysis set was include all subjects who have been randomized to receive SoC alone with target abdominal incision length >20 cm. In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received.

    Primary: Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event

    		 Close Top of page
    End point title
    		 Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event
    End point description
    Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event, occurring within 30 days post abdominal surgery and determined by a blinded independent adjudication committee. All-cause mortality and re-intervention at the primary incision site (target) due to suspected SSI or due to poor wound healing, including wound dehiscence (as verified by the blinded adjudication committee), within 30 days post index surgery will be analysed as treatment failure.
    End point type
    Primary
    End point timeframe
    30 days post-surgery
    End point values
    		 Investigational (D-PLEX) Control (SoC) ITT Incision >20cm (D-PLEX arm) Incision >20cm (SoC)
    Number of subjects analysed
    485
    489
    974
    212
    211
    Units: subjects
        Failure
    45
    59
    104
    17
    37
        Success
    440
    430
    870
    195
    174
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    Cochran-Mantel-Haenszel Test
    Comparison groups
    Investigational (D-PLEX) v Control (SoC)
    Number of subjects included in analysis
    974
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.152
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 1
    Statistical analysis title
    		 Subgroup analysis of subjectc with incision >20
    Statistical analysis description
    Pre-defined subgroup analysis
    Comparison groups
    Incision >20cm (D-PLEX arm) v Incision >20cm (SoC)
    Number of subjects included in analysis
    423
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0032 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -9.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.5
         upper limit
    		 -3.2
    Notes
    [1] - Nominal, not adjusted for multiple testing (not formal significance test)

    Secondary: First key secondary endpoint

    		 Close Top of page
    End point title
    		 First key secondary endpoint
    End point description
    Infection rate as measured by the proportion of subjects with at least one SSI event in the target incision, occurred within 30 days post abdominal index surgery, and determined by a blinded independent adjudication committee.
    End point type
    Secondary
    End point timeframe
    30 days post-surgery
    End point values
    		 Investigational (D-PLEX) Control (SoC) ITT Incision >20cm (D-PLEX arm) Incision >20cm (SoC)
    Number of subjects analysed
    485
    489
    974
    212
    211
    Units: subjects
        Failure
    29
    32
    61
    9
    19
        Success
    440
    435
    875
    195
    177
    Statistical analysis title
    		 First key secondary primary analysis
    Comparison groups
    Control (SoC) v Investigational (D-PLEX)
    Number of subjects included in analysis
    974
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6219
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 2.3
    Statistical analysis title
    		 First key secondary analysis of subjects with >20
    Comparison groups
    Incision >20cm (D-PLEX arm) v Incision >20cm (SoC)
    Number of subjects included in analysis
    423
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.041 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 -0.2
    Notes
    [2] - Nominal, not adjusted. Not a formal significance test

    Secondary: Second key secondary endpoint

    		 Close Top of page
    End point title
    		 Second key secondary endpoint
    End point description
    Number (percentage) of subjects with at least one score of ASEPSIS > 20 (further to an adjudicated SSI).
    End point type
    Secondary
    End point timeframe
    30 days post-surgery
    End point values
    		 Investigational (D-PLEX) Control (SoC) ITT Incision >20cm (D-PLEX arm) Incision >20cm (SoC)
    Number of subjects analysed
    485
    489
    936
    212
    211
    Units: subjects
        Failure
    8
    10
    18
    2
    5
        Success
    461
    457
    918
    202
    191
    Statistical analysis title
    		 Second key secondary primary analysis
    Comparison groups
    Investigational (D-PLEX) v Control (SoC)
    Number of subjects included in analysis
    974
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6238
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 1.3
    Statistical analysis title
    		 Second key secondary of subjects >20cm
    Comparison groups
    Incision >20cm (SoC) v Incision >20cm (D-PLEX arm)
    Number of subjects included in analysis
    423
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.276 [3]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 1
    Notes
    [3] - Nominal, not adjusted, not formal significance test

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    60 days post-surgery
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Investigational arm (D-PLEX)
    Reporting group description
    		 Subjects randomized to the investigational arm were treated with D-PLEX during the surgery (index procedure), as an adjunct to the SoC (see below). D-PLEX was applied during the closure of the abdominal target incision. D-PLEX was not re-administered if any reintervention occurs.

    Reporting group title
    Control (SoC)
    Reporting group description
    		 Subjects randomized to the control arm were treated only with prophylactic IV antibiotic according to SoC. Pre-operation prophylactic oral antibiotic was not allowed. Mechanical bowel preparation was at the discretion of the PI per each site's SOP

    Serious adverse events
    		 Investigational arm (D-PLEX) Control (SoC)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    69 / 478 (14.44%)
    98 / 498 (19.68%)
         number of deaths (all causes)
    16
    17
         number of deaths resulting from adverse events
    16
    17
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to liver
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    2 / 478 (0.42%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myeloid leukaemia
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Haemodynamic instability
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypotension
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 478 (0.21%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mucosal inflammation
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Female genital tract fistula
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis noninfective
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fluid collection
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic haemorrhage
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         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
    Respiratory failure
         subjects affected / exposed
    3 / 478 (0.63%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hydrothorax
         subjects affected / exposed
    0 / 478 (0.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Apnoea
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (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
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    SARS-CoV-1 test positive
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic leak
         subjects affected / exposed
    8 / 478 (1.67%)
    19 / 498 (3.82%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic complication
         subjects affected / exposed
    4 / 478 (0.84%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    2 / 478 (0.42%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    2 / 478 (0.42%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    0 / 478 (0.00%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic fistula
         subjects affected / exposed
    0 / 478 (0.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic haemorrhage
         subjects affected / exposed
    2 / 478 (0.42%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall wound
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinogenicity
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site haemorrhage
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suture related complication
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric injury
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    2 / 478 (0.42%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Cardiac failure acute
         subjects affected / exposed
    1 / 478 (0.21%)
    3 / 498 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Acute myocardial infarction
         subjects affected / exposed
    2 / 478 (0.42%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 478 (0.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiopulmonary failure
         subjects affected / exposed
    2 / 478 (0.42%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acute coronary syndrome
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (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
    Coma
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemorrhagic disorder
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    3 / 478 (0.63%)
    6 / 498 (1.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 478 (0.42%)
    5 / 498 (1.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 478 (0.21%)
    4 / 498 (0.80%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal necrosis
         subjects affected / exposed
    2 / 478 (0.42%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 478 (0.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal fluid collection
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic fistula
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocutaneous fistula
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoperitoneum
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis mesenteric vessel
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Hepatorenal failure
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 478 (0.42%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis noninfective
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Postoperative wound infection
         subjects affected / exposed
    8 / 478 (1.67%)
    6 / 498 (1.20%)
         occurrences causally related to treatment / all
    0 / 8
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    4 / 478 (0.84%)
    5 / 498 (1.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pneumonia
         subjects affected / exposed
    4 / 478 (0.84%)
    5 / 498 (1.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Abdominal abscess
         subjects affected / exposed
    4 / 478 (0.84%)
    4 / 498 (0.80%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    6 / 478 (1.26%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 478 (0.00%)
    4 / 498 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 478 (0.21%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    2 / 478 (0.42%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related bacteraemia
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endotoxic shock
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic infection
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia acinetobacter
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Purulent discharge
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site infection
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 498 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 498 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 478 (0.00%)
    2 / 498 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Investigational arm (D-PLEX) Control (SoC)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    381 / 478 (79.71%)
    398 / 498 (79.92%)
    Injury, poisoning and procedural complications
    Incision site pain
         subjects affected / exposed
    111 / 478 (23.22%)
    118 / 498 (23.69%)
         occurrences all number
    158
    167
    Procedural pain
         subjects affected / exposed
    83 / 478 (17.36%)
    87 / 498 (17.47%)
         occurrences all number
    87
    91
    Incision site erythema
         subjects affected / exposed
    52 / 478 (10.88%)
    52 / 498 (10.44%)
         occurrences all number
    52
    53
    Incision site discharge
         subjects affected / exposed
    53 / 478 (11.09%)
    37 / 498 (7.43%)
         occurrences all number
    54
    37
    Incision site swelling
         subjects affected / exposed
    25 / 478 (5.23%)
    23 / 498 (4.62%)
         occurrences all number
    25
    23
    Anastomotic leak
         subjects affected / exposed
    11 / 478 (2.30%)
    23 / 498 (4.62%)
         occurrences all number
    11
    23
    Vascular disorders
    Hypertension
         subjects affected / exposed
    11 / 478 (2.30%)
    7 / 498 (1.41%)
         occurrences all number
    11
    8
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    13 / 478 (2.72%)
    7 / 498 (1.41%)
         occurrences all number
    15
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    12 / 478 (2.51%)
    15 / 498 (3.01%)
         occurrences all number
    12
    15
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    83 / 478 (17.36%)
    85 / 498 (17.07%)
         occurrences all number
    83
    89
    Tenderness
         subjects affected / exposed
    63 / 478 (13.18%)
    64 / 498 (12.85%)
         occurrences all number
    63
    66
    Feeling hot
         subjects affected / exposed
    33 / 478 (6.90%)
    33 / 498 (6.63%)
         occurrences all number
    33
    33
    Pyrexia
         subjects affected / exposed
    16 / 478 (3.35%)
    23 / 498 (4.62%)
         occurrences all number
    18
    23
    Swelling
         subjects affected / exposed
    16 / 478 (3.35%)
    23 / 498 (4.62%)
         occurrences all number
    16
    23
    Asthenia
         subjects affected / exposed
    5 / 478 (1.05%)
    11 / 498 (2.21%)
         occurrences all number
    5
    11
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    41 / 478 (8.58%)
    52 / 498 (10.44%)
         occurrences all number
    42
    56
    Vomiting
         subjects affected / exposed
    29 / 478 (6.07%)
    21 / 498 (4.22%)
         occurrences all number
    30
    23
    Abdominal pain
         subjects affected / exposed
    21 / 478 (4.39%)
    17 / 498 (3.41%)
         occurrences all number
    21
    17
    Diarrhoea
         subjects affected / exposed
    19 / 478 (3.97%)
    18 / 498 (3.61%)
         occurrences all number
    20
    18
    Abdominal distension
         subjects affected / exposed
    6 / 478 (1.26%)
    11 / 498 (2.21%)
         occurrences all number
    6
    11
    Infections and infestations
    Postoperative wound infection
         subjects affected / exposed
    43 / 478 (9.00%)
    52 / 498 (10.44%)
         occurrences all number
    45
    56
    Urinary tract infection
         subjects affected / exposed
    8 / 478 (1.67%)
    16 / 498 (3.21%)
         occurrences all number
    8
    16
    COVID-19
         subjects affected / exposed
    9 / 478 (1.88%)
    13 / 498 (2.61%)
         occurrences all number
    10
    13
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    11 / 478 (2.30%)
    11 / 498 (2.21%)
         occurrences all number
    11
    11

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Dec 2019
    • Changes in study design due to re-evaluation of the overall infection rate in Europe and US regions • Implementation of HPRA recommendations
    05 May 2020
    Changes in study design due re-evaluation of overall infection rate in Europe and US regions and FDA recommendations.
    19 Aug 2020
    Changes in study design following FDA review of the protocol.
    08 Nov 2021
    Changes in study design following study procedures clarifications, EU regulatory authorities requests harmonized in this version.
    22 Feb 2022
    Update of study end points and sample size calculation as agreed with FDA.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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

    European Medicines Agency © 1995-Thu May 02 05:40:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA