Trial Outcomes & Findings for D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II) (NCT NCT04411199)
NCT ID: NCT04411199
Last Updated: 2026-07-13
Results Overview
The primary analysis is based on a composite treatment-failure (Yes/No) variable, indicating if a subject had at least one treatment-failure event, defined as follows: SSI, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, death (from any reason) or re-intervention at the target incision site within 30 days post surgery will be considered a treatment failure for the primary ITT analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
975 participants
Primary outcome timeframe
By day 30 post surgery
Results posted on
2026-07-13
Participant Flow
Participant milestones
| Measure |
D-PLEX + Standard of Care (SoC)
D-PLEX is provided to subjects as an adjunct to the Standard of Care (SoC) treatment.
|
Standard of Care (SoC)
The subjects receive the Standard of Care (SoC) treatment alone. This is a prophylactic antibiotic treatment which is based on the international guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
487
|
488
|
|
Overall Study
Number of Subjects in the ITT Population
|
405
|
393
|
|
Overall Study
Number of Subjects Who Received Treatment (Safety Population)
|
481
|
493
|
|
Overall Study
COMPLETED
|
469
|
462
|
|
Overall Study
NOT COMPLETED
|
18
|
26
|
Reasons for withdrawal
| Measure |
D-PLEX + Standard of Care (SoC)
D-PLEX is provided to subjects as an adjunct to the Standard of Care (SoC) treatment.
|
Standard of Care (SoC)
The subjects receive the Standard of Care (SoC) treatment alone. This is a prophylactic antibiotic treatment which is based on the international guidelines.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Death
|
10
|
19
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Logistical issue
|
1
|
0
|
|
Overall Study
Trans anal excision was done
|
1
|
0
|
Baseline Characteristics
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
Baseline characteristics by cohort
| Measure |
D-PLEX + Standard of Care
n=487 Participants
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment.
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=488 Participants
The Standard of Care (SoC) for prophylactic antibiotic treatment is based on international guidelines per institution guidelines.
|
Total
n=975 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 12.13 • n=20 Participants
|
66.1 years
STANDARD_DEVIATION 11.65 • n=20 Participants
|
65.6 years
STANDARD_DEVIATION 11.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
219 Participants
n=20 Participants
|
200 Participants
n=20 Participants
|
419 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
268 Participants
n=20 Participants
|
288 Participants
n=20 Participants
|
556 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
487 Participants
n=20 Participants
|
486 Participants
n=20 Participants
|
973 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
Romania
|
54 participants
n=20 Participants
|
50 participants
n=20 Participants
|
104 participants
n=40 Participants
|
|
Region of Enrollment
Hungary
|
95 participants
n=20 Participants
|
86 participants
n=20 Participants
|
181 participants
n=40 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=20 Participants
|
3 participants
n=20 Participants
|
4 participants
n=40 Participants
|
|
Region of Enrollment
Moldova
|
129 participants
n=20 Participants
|
117 participants
n=20 Participants
|
246 participants
n=40 Participants
|
|
Region of Enrollment
Portugal
|
14 participants
n=20 Participants
|
10 participants
n=20 Participants
|
24 participants
n=40 Participants
|
|
Region of Enrollment
Ireland
|
4 participants
n=20 Participants
|
1 participants
n=20 Participants
|
5 participants
n=40 Participants
|
|
Region of Enrollment
North Macedonia
|
54 participants
n=20 Participants
|
59 participants
n=20 Participants
|
113 participants
n=40 Participants
|
|
Region of Enrollment
Poland
|
14 participants
n=20 Participants
|
9 participants
n=20 Participants
|
23 participants
n=40 Participants
|
|
Region of Enrollment
Georgia
|
6 participants
n=20 Participants
|
8 participants
n=20 Participants
|
14 participants
n=40 Participants
|
|
Region of Enrollment
Israel
|
21 participants
n=20 Participants
|
34 participants
n=20 Participants
|
55 participants
n=40 Participants
|
|
Region of Enrollment
Serbia
|
59 participants
n=20 Participants
|
76 participants
n=20 Participants
|
135 participants
n=40 Participants
|
|
Region of Enrollment
Bosnia and Herzegovina
|
34 participants
n=20 Participants
|
34 participants
n=20 Participants
|
68 participants
n=40 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=20 Participants
|
1 participants
n=20 Participants
|
3 participants
n=40 Participants
|
|
BMI
|
26.81 kg/m^2
STANDARD_DEVIATION 4.77 • n=20 Participants
|
26.72 kg/m^2
STANDARD_DEVIATION 4.59 • n=20 Participants
|
26.76 kg/m^2
STANDARD_DEVIATION 4.67 • n=40 Participants
|
PRIMARY outcome
Timeframe: By day 30 post surgeryPopulation: Intent To Treat
The primary analysis is based on a composite treatment-failure (Yes/No) variable, indicating if a subject had at least one treatment-failure event, defined as follows: SSI, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, death (from any reason) or re-intervention at the target incision site within 30 days post surgery will be considered a treatment failure for the primary ITT analysis.
Outcome measures
| Measure |
D-PLEX + Standard of Care (SoC)
n=405 Participants
D-PLEX is provided to subjects as an adjunct to the Standard of Care (SoC) treatment.
|
Standard of Care (SoC)
n=393 Participants
The subjects receive the Standard of Care (SoC) treatment alone. This is a prophylactic antibiotic treatment which is based on the international guidelines.
|
|---|---|---|
|
Infection Rate as Measured by the Percentage of Subjects With SSI Event in the Target Incision Within 30 Days Post Index Surgery or Re-interventions or Death [for Any Reason] in the Population of Subjects With Target Incision Length >20 cm
|
10.9 percentage of participants
Interval 8.0 to 14.3
|
18.1 percentage of participants
Interval 14.4 to 22.2
|
SECONDARY outcome
Timeframe: By day 30 post surgeryPopulation: The number of evaluable subjects from the intent to treat population, with non-missing outcome data.
Infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, occurring within 30 days post abdominal (index) surgery and determined by a blinded and independent adjudication committee. \[abdominal incisional infection is defined as Deep Incisional Surgical Site Infection (DSSI) and/or Superficial Incisional Surgical Site Infection (SSSI)\].
Outcome measures
| Measure |
D-PLEX + Standard of Care (SoC)
n=391 Participants
D-PLEX is provided to subjects as an adjunct to the Standard of Care (SoC) treatment.
|
Standard of Care (SoC)
n=377 Participants
The subjects receive the Standard of Care (SoC) treatment alone. This is a prophylactic antibiotic treatment which is based on the international guidelines.
|
|---|---|---|
|
The Percentage of Subjects With at Least One SSI Event in the Target Incision
|
3.8 percentage of participants
Interval 2.2 to 6.2
|
9.5 percentage of participants
Interval 6.8 to 13.0
|
SECONDARY outcome
Timeframe: 30 days post surgeryPopulation: All randomized population
The primary analysis is based on a composite treatment-failure (Yes/No) variable, indicating if a subject had at least one treatment-failure event, defined as follows: SSI, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, and target incision length \> 7 cm, death (from any reason) or re-intervention at the target incision site within 30 days post surgery will be considered a treatment failure.
Outcome measures
| Measure |
D-PLEX + Standard of Care (SoC)
n=487 Participants
D-PLEX is provided to subjects as an adjunct to the Standard of Care (SoC) treatment.
|
Standard of Care (SoC)
n=488 Participants
The subjects receive the Standard of Care (SoC) treatment alone. This is a prophylactic antibiotic treatment which is based on the international guidelines.
|
|---|---|---|
|
Infection Rate as Measured by the Percentage of Subjects With SSI Event in the Target Incision Within 30 Days Post Index Surgery or Re-interventions or Death [for Any Reason] in the Population of Subjects With Target Incision Length >7 cm
|
11.1 percentage of participants
Interval 8.4 to 14.2
|
17.4 percentage of participants
Interval 14.2 to 21.1
|
SECONDARY outcome
Timeframe: 30 days post surgeryPopulation: Intent to treat subjects with ASEPSIS\>20 score further to an adjudicated SSI within 30 days post abdominal surgery, with non-missing data
ASEPSIS (Additional Treatment, Serous Discharge, Erythema, Purulent Exudates, Separation of Deep Tissue, Isolation of Bacteria, Stay as In Patient) is an acronym of wound assessment and treatment parameters, which provides numerically score during an inspection of the surgical site. The final score is being interpreted to severity of wound appearance and the clinical consequences of the infection.
Outcome measures
| Measure |
D-PLEX + Standard of Care (SoC)
n=391 Participants
D-PLEX is provided to subjects as an adjunct to the Standard of Care (SoC) treatment.
|
Standard of Care (SoC)
n=377 Participants
The subjects receive the Standard of Care (SoC) treatment alone. This is a prophylactic antibiotic treatment which is based on the international guidelines.
|
|---|---|---|
|
Percentage of Subjects With at Least 1 Score of ASEPSIS> 20, Within 30 Days Post Abdominal (Index) Surgery
|
2 Percentage of the participants
Interval 0.9 to 4.0
|
5.6 Percentage of the participants
Interval 3.5 to 8.4
|
Adverse Events
D-PLEX + Standard of Care (SoC)
Serious events: 75 serious events
Other events: 399 other events
Deaths: 10 deaths
Standard of Care (SoC)
Serious events: 85 serious events
Other events: 401 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
D-PLEX + Standard of Care (SoC)
n=481 participants at risk
D-PLEX is provided to subjects as an adjunct to the Standard of Care (SoC) treatment.
|
Standard of Care (SoC)
n=493 participants at risk
The subjects receive the Standard of Care (SoC) treatment alone. This is a prophylactic antibiotic treatment which is based on the international guidelines.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.21%
1/481 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Cardiac disorders
Cardiac Arrest
|
0.83%
4/481 • Number of events 4 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.81%
4/493 • Number of events 4 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.61%
3/493 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
6/481 • Number of events 6 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.81%
4/493 • Number of events 4 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.21%
1/481 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.61%
3/493 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.61%
3/493 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.20%
1/493 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.21%
1/481 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.00%
0/493 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Ileus
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.00%
0/493 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
General disorders
Death
|
0.21%
1/481 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.61%
3/493 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.20%
1/493 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Infections and infestations
Postoperative wound infection
|
0.62%
3/481 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
2.0%
10/493 • Number of events 10 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Infections and infestations
Peritonitis
|
1.0%
5/481 • Number of events 5 • 60 days
Adverse Event population is calculated out of the Safety Population
|
1.4%
7/493 • Number of events 7 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Infections and infestations
Septic shock
|
1.0%
5/481 • Number of events 5 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.81%
4/493 • Number of events 4 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Infections and infestations
Pneumonia
|
0.83%
4/481 • Number of events 4 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.61%
3/493 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.61%
3/493 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Infections and infestations
Pelvic abscess
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.20%
1/493 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
1.9%
9/481 • Number of events 9 • 60 days
Adverse Event population is calculated out of the Safety Population
|
2.6%
13/493 • Number of events 13 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
1.2%
6/481 • Number of events 6 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.61%
3/493 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Incision site impaired healing
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Stoma complication
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.00%
0/493 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Investigations
Investigations
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.20%
1/493 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.20%
1/493 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.21%
1/481 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Nervous system disorders
Nervous system disorders
|
0.21%
1/481 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.61%
3/493 • Number of events 5 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Renal and urinary disorders
Acute kidney injury
|
0.21%
1/481 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Renal and urinary disorders
Renal failure
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.20%
1/493 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.21%
1/481 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.20%
1/493 • Number of events 1 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.61%
3/493 • Number of events 3 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/481 • 60 days
Adverse Event population is calculated out of the Safety Population
|
0.41%
2/493 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
Other adverse events
| Measure |
D-PLEX + Standard of Care (SoC)
n=481 participants at risk
D-PLEX is provided to subjects as an adjunct to the Standard of Care (SoC) treatment.
|
Standard of Care (SoC)
n=493 participants at risk
The subjects receive the Standard of Care (SoC) treatment alone. This is a prophylactic antibiotic treatment which is based on the international guidelines.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.4%
26/481 • Number of events 26 • 60 days
Adverse Event population is calculated out of the Safety Population
|
5.7%
28/493 • Number of events 29 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
13/481 • Number of events 13 • 60 days
Adverse Event population is calculated out of the Safety Population
|
3.4%
17/493 • Number of events 18 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
17/481 • Number of events 18 • 60 days
Adverse Event population is calculated out of the Safety Population
|
5.1%
25/493 • Number of events 27 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
14/481 • Number of events 15 • 60 days
Adverse Event population is calculated out of the Safety Population
|
2.4%
12/493 • Number of events 13 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Constipation
|
1.7%
8/481 • Number of events 8 • 60 days
Adverse Event population is calculated out of the Safety Population
|
3.4%
17/493 • Number of events 17 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
8/481 • Number of events 10 • 60 days
Adverse Event population is calculated out of the Safety Population
|
3.2%
16/493 • Number of events 16 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
General disorders
Feeling hot
|
8.3%
40/481 • Number of events 41 • 60 days
Adverse Event population is calculated out of the Safety Population
|
6.9%
34/493 • Number of events 34 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
General disorders
Pain
|
3.3%
16/481 • Number of events 16 • 60 days
Adverse Event population is calculated out of the Safety Population
|
2.6%
13/493 • Number of events 13 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
General disorders
Pyrexia
|
2.7%
13/481 • Number of events 18 • 60 days
Adverse Event population is calculated out of the Safety Population
|
3.0%
15/493 • Number of events 16 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Infections and infestations
Postoperative wound infection
|
5.6%
27/481 • Number of events 30 • 60 days
Adverse Event population is calculated out of the Safety Population
|
11.6%
57/493 • Number of events 60 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Infections and infestations
Urinary tract infection
|
2.5%
12/481 • Number of events 12 • 60 days
Adverse Event population is calculated out of the Safety Population
|
2.4%
12/493 • Number of events 12 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Infections and infestations
Peritonitis
|
1.7%
8/481 • Number of events 8 • 60 days
Adverse Event population is calculated out of the Safety Population
|
2.0%
10/493 • Number of events 10 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Incision site pain
|
47.8%
230/481 • Number of events 353 • 60 days
Adverse Event population is calculated out of the Safety Population
|
42.6%
210/493 • Number of events 332 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.6%
51/481 • Number of events 53 • 60 days
Adverse Event population is calculated out of the Safety Population
|
13.4%
66/493 • Number of events 68 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
13.5%
65/481 • Number of events 70 • 60 days
Adverse Event population is calculated out of the Safety Population
|
9.3%
46/493 • Number of events 47 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Incision site swelling
|
12.1%
58/481 • Number of events 61 • 60 days
Adverse Event population is calculated out of the Safety Population
|
9.1%
45/493 • Number of events 45 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Incision site discharge
|
10.2%
49/481 • Number of events 50 • 60 days
Adverse Event population is calculated out of the Safety Population
|
8.7%
43/493 • Number of events 44 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
5.2%
25/481 • Number of events 26 • 60 days
Adverse Event population is calculated out of the Safety Population
|
1.6%
8/493 • Number of events 9 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
1.9%
9/481 • Number of events 11 • 60 days
Adverse Event population is calculated out of the Safety Population
|
3.0%
15/493 • Number of events 15 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
2.3%
11/481 • Number of events 11 • 60 days
Adverse Event population is calculated out of the Safety Population
|
1.0%
5/493 • Number of events 5 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Investigations
C-reactive protein increased
|
2.9%
14/481 • Number of events 14 • 60 days
Adverse Event population is calculated out of the Safety Population
|
1.6%
8/493 • Number of events 8 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Investigations
Oxygen saturation decreased
|
0.42%
2/481 • Number of events 2 • 60 days
Adverse Event population is calculated out of the Safety Population
|
2.0%
10/493 • Number of events 10 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.7%
8/481 • Number of events 8 • 60 days
Adverse Event population is calculated out of the Safety Population
|
2.2%
11/493 • Number of events 11 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
2.7%
13/481 • Number of events 13 • 60 days
Adverse Event population is calculated out of the Safety Population
|
3.0%
15/493 • Number of events 15 • 60 days
Adverse Event population is calculated out of the Safety Population
|
|
Vascular disorders
Hypertension
|
0.83%
4/481 • Number of events 4 • 60 days
Adverse Event population is calculated out of the Safety Population
|
2.0%
10/493 • Number of events 10 • 60 days
Adverse Event population is calculated out of the Safety Population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place