Trial Outcomes & Findings for D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (NCT NCT04233424)

Last Updated: 2026-01-21

Results Overview

Infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, as determined by a blinded and independent adjudication committee, within 30 days post-abdominal surgery. \[Abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)\]. The blinded and independent adjudication committee review will include all index surgery incisions, regardless of any re-intervention at the target site, for the determination of infection status. The committee will also assess re-interventions at the primary incision site through the abdominal incision (target) for the determination of re-intervention due to suspected SSI or due to poor wound healing, including wound dehiscence. Such events, as well as all-cause mortality within 30 days post-index surgery will be analyzed as treatment failure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

977 participants

Primary outcome timeframe

By day 30 post surgery

Results posted on

2026-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	D-PLEX+SoC D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D-PLEX: D-PLEX is a new formulation of extended release of Doxycycline.	Standard of Care The SoC for prophylactic antibiotic treatment is based on international guidelines Standard of Care (SoC): prophylactic, pre-operation per institution guidelines
Overall Study STARTED	488	489
Overall Study Number of Subjects in the ITT Population	485	489
Overall Study Actual number of subjects treated in each treatment group	478	498
Overall Study COMPLETED	464	458
Overall Study NOT COMPLETED	24	31

Reasons for withdrawal

Reasons for withdrawal
Measure	D-PLEX+SoC D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D-PLEX: D-PLEX is a new formulation of extended release of Doxycycline.	Standard of Care The SoC for prophylactic antibiotic treatment is based on international guidelines Standard of Care (SoC): prophylactic, pre-operation per institution guidelines
Overall Study Death	15	16
Overall Study Withdrawal by Subject	2	8
Overall Study Physician Decision	1	3
Overall Study Protocol Violation	3	1
Overall Study Lost to Follow-up	1	3
Overall Study subject refuse to visit site	2	0

Baseline Characteristics

D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D-PLEX+SoC n=485 Participants D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D-PLEX: D-PLEX is a new formulation of extended release of Doxycycline.	Standard of Care n=489 Participants The SoC for prophylactic antibiotic treatment is based on international guidelines Standard of Care (SoC): prophylactic, pre-operation per institution guidelines	Total n=974 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 12.75 • n=37 Participants	63.7 years STANDARD_DEVIATION 13.27 • n=44 Participants	64.2 years STANDARD_DEVIATION 13.02 • n=40 Participants
Sex: Female, Male Female	197 Participants n=37 Participants	198 Participants n=44 Participants	395 Participants n=40 Participants
Sex: Female, Male Male	288 Participants n=37 Participants	291 Participants n=44 Participants	579 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants	1 Participants n=44 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	1 Participants n=37 Participants	2 Participants n=44 Participants	3 Participants n=40 Participants
Race (NIH/OMB) White	483 Participants n=37 Participants	486 Participants n=44 Participants	969 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	0 Participants n=44 Participants	1 Participants n=40 Participants
Region of Enrollment Romania	82 Participants n=37 Participants	86 Participants n=44 Participants	168 Participants n=40 Participants
Region of Enrollment Hungary	84 Participants n=37 Participants	76 Participants n=44 Participants	160 Participants n=40 Participants
Region of Enrollment United States	18 Participants n=37 Participants	19 Participants n=44 Participants	37 Participants n=40 Participants
Region of Enrollment Czechia	64 Participants n=37 Participants	67 Participants n=44 Participants	131 Participants n=40 Participants
Region of Enrollment Moldova	84 Participants n=37 Participants	93 Participants n=44 Participants	177 Participants n=40 Participants
Region of Enrollment Israel	67 Participants n=37 Participants	71 Participants n=44 Participants	138 Participants n=40 Participants
Region of Enrollment Bulgaria	47 Participants n=37 Participants	45 Participants n=44 Participants	92 Participants n=40 Participants
Region of Enrollment Croatia	26 Participants n=37 Participants	14 Participants n=44 Participants	40 Participants n=40 Participants
Region of Enrollment Poland	8 Participants n=37 Participants	9 Participants n=44 Participants	17 Participants n=40 Participants
Region of Enrollment Slovakia	5 Participants n=37 Participants	9 Participants n=44 Participants	14 Participants n=40 Participants
BMI	26.80 kg/m^2 STANDARD_DEVIATION 4.54 • n=37 Participants	27.11 kg/m^2 STANDARD_DEVIATION 4.65 • n=44 Participants	26.96 kg/m^2 STANDARD_DEVIATION 4.60 • n=40 Participants

PRIMARY outcome

Timeframe: By day 30 post surgery

Population: Intent to treat population

Outcome measures

Outcome measures
Measure	D-PLEX+SoC n=485 Participants D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D-PLEX: D-PLEX is a new formulation of extended release of Doxycycline.	Standard of Care n=489 Participants The SoC for prophylactic antibiotic treatment is based on international guidelines Standard of Care (SoC): prophylactic, pre-operation per institution guidelines
To Assess the Anti-infective Efficacy of D-PLEX Over a Period of 30 Days Post Operation, by Preventing Surgical Site Infection (SSI), Defined as Superficial and Deep Infection, in the Target Incision(s), Compared to the SoC Treated Control.	9.3 percentage of participants Interval 6.8 to 12.2	12.1 percentage of participants Interval 9.3 to 15.3

SECONDARY outcome

Timeframe: 30 days post-surgery

Population: Intent to treat population

infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, as determined by a blinded and independent adjudication committee, within 30 days post abdominal surgery. \[abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)\].

Outcome measures

Outcome measures
Measure	D-PLEX+SoC n=485 Participants D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D-PLEX: D-PLEX is a new formulation of extended release of Doxycycline.	Standard of Care n=489 Participants The SoC for prophylactic antibiotic treatment is based on international guidelines Standard of Care (SoC): prophylactic, pre-operation per institution guidelines
Assessment of Infection Rate in Patient Undergoing Abdominal Colon Surgery	6.2 Percentage of the participants Interval 4.2 to 8.8	6.9 Percentage of the participants Interval 4.7 to 9.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 day post surgery

Population: All-cause mortality is calculated out of the ITT population

All-cause mortality within 30 days post index surgery will be analysed as treatment failure.

Outcome measures

Outcome measures
Measure	D-PLEX+SoC n=485 Participants D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D-PLEX: D-PLEX is a new formulation of extended release of Doxycycline.	Standard of Care n=489 Participants The SoC for prophylactic antibiotic treatment is based on international guidelines Standard of Care (SoC): prophylactic, pre-operation per institution guidelines
All-cause Mortality	2.3 percentage of participants Interval 1.3 to 4.1	3.1 percentage of participants Interval 1.9 to 5.1

Adverse Events

D-PLEX+SoC

Serious events: 69 serious events

Other events: 381 other events

Deaths: 16 deaths

Standard of Care

Serious events: 98 serious events

Other events: 398 other events

Deaths: 17 deaths

Serious adverse events

Other adverse events

Additional Information

Eyal Shoshani, VP Clinical Affairs

PolyPid

Phone: +972-74-7195700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	D-PLEX+SoC n=478 participants at risk D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D-PLEX: D-PLEX is a new formulation of extended release of Doxycycline. Each 5g D-PLEX vial contains 54.6mg Doxycycline free base (1.09%), which is equivalent to 63mg Doxycycline hyclate (1.26%). D-PLEX is supplied as a sterile powder to be reconstituted to paste in the operating room, using standard aseptic techniques and is intended for single administration. The non-active components of the extended release antibiotic formulation are β Tri-Calcium polymer and a lipid matrix. All formulation components are biodegradable.	Standard of Care n=498 participants at risk The SoC for prophylactic antibiotic treatment is based on international guidelines Standard of Care (SoC): prophylactic, pre-operation per institution guidelines
Blood and lymphatic system disorders Haemorrhagic disorder	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Anastomotic leak	1.7% 8/478 • Number of events 8 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	3.8% 19/498 • Number of events 19 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Cardiac failure	0.42% 2/478 • Number of events 2 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.40% 2/498 • Number of events 2 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Small intestinal obstruction	0.63% 3/478 • Number of events 3 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.2% 6/498 • Number of events 6 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Cardiac failure acute	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.60% 3/498 • Number of events 3 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Acute myocardial infarction	0.42% 2/478 • Number of events 2 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.00% 0/498 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Cardiac arrest	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.40% 2/498 • Number of events 2 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Cardiopulmonary failure	0.42% 2/478 • Number of events 2 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.00% 0/498 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Bradyarrhythmia	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Acute coronary syndrome	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.00% 0/498 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Cardiovascular insufficiency	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Myocardial infarction	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.00% 0/498 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Ileus	0.42% 2/478 • Number of events 2 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.0% 5/498 • Number of events 5 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Intestinal obstruction	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.80% 4/498 • Number of events 4 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Gastrointestinal necrosis	0.42% 2/478 • Number of events 2 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Intestinal fistula	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Intestinal ischemia	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.40% 2/498 • Number of events 2 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Intra-abdominal fluid collection	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Mechanical ileus	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Small intestinal perforation	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Abdominal pain	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Abdominal pain lower	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.00% 0/498 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Anal fissure	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.00% 0/498 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Ascites	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Colonic fistula	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Crohn's disease	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Diarrhea	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Dysphagia	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.00% 0/498 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Enterocolitis	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Enterocutaneous fistula	0.21% 1/478 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.00% 0/498 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Gastric ulcer hemorrhage	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Ileus paralytic	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Pancreatitis	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Proctitis	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/478 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.

Other adverse events
Measure	D-PLEX+SoC n=478 participants at risk D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D-PLEX: D-PLEX is a new formulation of extended release of Doxycycline. Each 5g D-PLEX vial contains 54.6mg Doxycycline free base (1.09%), which is equivalent to 63mg Doxycycline hyclate (1.26%). D-PLEX is supplied as a sterile powder to be reconstituted to paste in the operating room, using standard aseptic techniques and is intended for single administration. The non-active components of the extended release antibiotic formulation are β Tri-Calcium polymer and a lipid matrix. All formulation components are biodegradable.	Standard of Care n=498 participants at risk The SoC for prophylactic antibiotic treatment is based on international guidelines Standard of Care (SoC): prophylactic, pre-operation per institution guidelines
Blood and lymphatic system disorders Anaemia	2.5% 12/478 • Number of events 12 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	3.0% 15/498 • Number of events 15 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Cardiac disorders Tachycardia	2.7% 13/478 • Number of events 15 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.4% 7/498 • Number of events 7 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Nausea	8.6% 41/478 • Number of events 42 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	10.4% 52/498 • Number of events 56 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Vomiting	6.1% 29/478 • Number of events 30 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	4.2% 21/498 • Number of events 23 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Abdominal Pain	4.4% 21/478 • Number of events 21 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	3.4% 17/498 • Number of events 17 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Diarrhea	4.0% 19/478 • Number of events 20 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	3.6% 18/498 • Number of events 18 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Abdominal Distension	1.3% 6/478 • Number of events 6 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	2.2% 11/498 • Number of events 11 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Constipation	1.3% 6/478 • Number of events 6 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	2.2% 11/498 • Number of events 12 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Ileus	1.5% 7/478 • Number of events 7 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.2% 6/498 • Number of events 6 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Dyspepsia	1.0% 5/478 • Number of events 5 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.80% 4/498 • Number of events 4 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Abdominal Pain Upper	1.0% 5/478 • Number of events 5 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.60% 3/498 • Number of events 3 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Small Intestinal Obstruction	0.84% 4/478 • Number of events 4 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.2% 6/498 • Number of events 6 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Gastrointestinal disorders Haematochezia	0.63% 3/478 • Number of events 3 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.0% 5/498 • Number of events 5 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
General disorders Pain	17.4% 83/478 • Number of events 83 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	17.1% 85/498 • Number of events 89 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
General disorders Tenderness	13.2% 63/478 • Number of events 63 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	12.9% 64/498 • Number of events 66 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
General disorders Feeling Hot	6.9% 33/478 • Number of events 33 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	6.6% 33/498 • Number of events 33 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
General disorders Pyrexia	3.3% 16/478 • Number of events 18 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	4.6% 23/498 • Number of events 23 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
General disorders Swelling	3.3% 16/478 • Number of events 16 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	4.6% 23/498 • Number of events 23 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
General disorders Asthenia	1.0% 5/478 • Number of events 5 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	2.2% 11/498 • Number of events 11 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
General disorders Impaired Healing	1.5% 7/478 • Number of events 7 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.20% 1/498 • Number of events 1 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
General disorders Oedema Peripheral	0.42% 2/478 • Number of events 2 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.2% 6/498 • Number of events 6 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
General disorders Secretion Discharge	1.0% 5/478 • Number of events 5 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.40% 2/498 • Number of events 2 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Infections and infestations Postoperative Wound Infection	9.0% 43/478 • Number of events 45 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	10.4% 52/498 • Number of events 56 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Infections and infestations Urinary Tract Infection	1.7% 8/478 • Number of events 8 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	3.2% 16/498 • Number of events 16 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Infections and infestations COVID-19	1.9% 9/478 • Number of events 10 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	2.6% 13/498 • Number of events 13 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Infections and infestations Pneumonia	1.9% 9/478 • Number of events 9 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.8% 9/498 • Number of events 9 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Incision Site Pain	23.2% 111/478 • Number of events 158 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	23.7% 118/498 • Number of events 167 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Procedural Pain	17.4% 83/478 • Number of events 87 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	17.5% 87/498 • Number of events 91 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Incision Site Erythema	10.9% 52/478 • Number of events 52 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	10.4% 52/498 • Number of events 53 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Incision Site Discharge	11.1% 53/478 • Number of events 54 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	7.4% 37/498 • Number of events 37 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Incision Site Swelling	5.2% 25/478 • Number of events 25 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	4.6% 23/498 • Number of events 23 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Anastomotic Leak	2.3% 11/478 • Number of events 11 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	4.6% 23/498 • Number of events 23 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Procedural Haemorrhage	1.7% 8/478 • Number of events 8 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.0% 5/498 • Number of events 5 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Incision Site Haematoma	1.5% 7/478 • Number of events 7 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.80% 4/498 • Number of events 4 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Wound dehiscence	1.3% 6/478 • Number of events 6 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.0% 5/498 • Number of events 5 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Injury, poisoning and procedural complications Anastomotic Complication	1.3% 6/478 • Number of events 6 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	0.60% 3/498 • Number of events 3 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Infections and infestations Incision Site Haemorrhage	0.63% 3/478 • Number of events 3 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.0% 5/498 • Number of events 6 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Investigations Oxygen Saturation Decreased	2.7% 13/478 • Number of events 13 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	3.2% 16/498 • Number of events 17 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Investigations Haemoglobin Decreased	1.7% 8/478 • Number of events 8 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	2.2% 11/498 • Number of events 11 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.
Investigations C-reactive Protein Increased	1.5% 7/478 • Number of events 7 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.	1.4% 7/498 • Number of events 7 • 60 days Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. "Lack of efficacy" or "failure of expected pharmacology action" per se will not be reported as an AE or SAE. However, the signs and symptoms and/or clinical sequelae resulting from lack of efficacy will be reported if they fulfil the definition of an AE or SAE.