Trial Outcomes & Findings for NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies (NCT NCT04955730)
NCT ID: NCT04955730
Last Updated: 2026-03-02
Results Overview
Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Superficial Incisions.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2/PHASE3
Target enrollment
290 participants
Primary outcome timeframe
30 days post operation
Results posted on
2026-03-02
Participant Flow
Participant milestones
| Measure |
NPWT - Negative Pressure Wound Therapy
Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
|
Standard of Care Wound Therapy
Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
96
|
|
Overall Study
COMPLETED
|
183
|
94
|
|
Overall Study
NOT COMPLETED
|
11
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies
Baseline characteristics by cohort
| Measure |
NPWT - Negative Pressure Wound Therapy
n=194 Participants
Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
|
Standard of Care Wound Therapy
n=96 Participants
Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Age, Customized
30-39
|
6 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
9 Participants
n=76 Participants
|
|
Age, Customized
40-49
|
18 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
35 Participants
n=76 Participants
|
|
Age, Customized
50-59
|
44 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
60 Participants
n=76 Participants
|
|
Age, Customized
60-69
|
73 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
97 Participants
n=76 Participants
|
|
Age, Customized
70-79
|
50 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
78 Participants
n=76 Participants
|
|
Age, Customized
80-89
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
10 Participants
n=76 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
99 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
191 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
39 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
166 Participants
n=41 Participants
|
74 Participants
n=35 Participants
|
240 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
11 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
16 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
189 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
46 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
63 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
18 Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
194 participants
n=41 Participants
|
96 participants
n=35 Participants
|
290 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: 30 days post operationPopulation: All participants were evaluated
Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Superficial Incisions.
Outcome measures
| Measure |
NPWT - Negative Pressure Wound Therapy
n=183 Participants
Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
|
Standard of Care Wound Therapy
n=94 Participants
Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
|
|---|---|---|
|
Surgical Site Infection - Superficial Incisional
|
18 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 30 days post operationPopulation: All participants were evaluated
Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Deep Incisions.
Outcome measures
| Measure |
NPWT - Negative Pressure Wound Therapy
n=183 Participants
Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
|
Standard of Care Wound Therapy
n=94 Participants
Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
|
|---|---|---|
|
Surgical Site Infection - Deep Incisional
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 30 days post operationPopulation: All participants were evaluated
Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Organ/Space Incisions.
Outcome measures
| Measure |
NPWT - Negative Pressure Wound Therapy
n=183 Participants
Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
|
Standard of Care Wound Therapy
n=94 Participants
Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
|
|---|---|---|
|
Surgical Site Infection - Organ/Space Incisional
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months after surgeryPopulation: All participants were evaluated
Investigators will measure number of participants who returned to their intended oncologic therapy
Outcome measures
| Measure |
NPWT - Negative Pressure Wound Therapy
n=183 Participants
Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
|
Standard of Care Wound Therapy
n=94 Participants
Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
|
|---|---|---|
|
Return to Intended Oncologic Therapy (RIOT)
|
89.3 percentage of participants
|
87.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 months after surgeryPopulation: All participants were evaluated
Investigators will measure time to initiation planned therapy from the surgery date to initiation date of planned oncologic therapy
Outcome measures
| Measure |
NPWT - Negative Pressure Wound Therapy
n=183 Participants
Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
|
Standard of Care Wound Therapy
n=94 Participants
Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
|
|---|---|---|
|
Time to Initiation of Planned Oncologic Therapy
|
1.69 Months
Interval 0.69 to 12.4
|
2.04 Months
Interval 0.39 to 13.4
|
Adverse Events
NPWT - Negative Pressure Wound Therapy
Serious events: 36 serious events
Other events: 62 other events
Deaths: 3 deaths
Standard of Care Wound Therapy
Serious events: 18 serious events
Other events: 29 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
NPWT - Negative Pressure Wound Therapy
n=194 participants at risk
Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
|
Standard of Care Wound Therapy
n=96 participants at risk
Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.52%
1/194 • Number of events 1 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Pancreatic anastomotic leak
|
0.52%
1/194 • Number of events 1 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Investigations
Blood bilirubin increased
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.52%
1/194 • Number of events 1 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Nervous system disorders
Vasovagal reaction
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Psychiatric disorders
Confusion
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Psychiatric disorders
Delirium
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
2/194 • Number of events 2 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Urinary retention
|
0.52%
1/194 • Number of events 1 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.52%
1/194 • Number of events 1 • 6 months
|
3.1%
3/96 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.52%
1/194 • Number of events 1 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
4/194 • Number of events 4 • 6 months
|
3.1%
3/96 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.0%
2/194 • Number of events 2 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Ileus
|
1.0%
2/194 • Number of events 2 • 6 months
|
4.2%
4/96 • Number of events 4 • 6 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
General disorders
Fever
|
0.52%
1/194 • Number of events 1 • 6 months
|
3.1%
3/96 • Number of events 3 • 6 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/194 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Hepatobiliary disorders
Perforation bile duct
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/194 • 6 months
|
3.1%
3/96 • Number of events 4 • 6 months
|
|
Infections and infestations
Abdominal infection
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Bacteremia
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Pancreas infection
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Pleural infection
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Wound infection
|
2.6%
5/194 • Number of events 6 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/194 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
0.52%
1/194 • Number of events 1 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
2/194 • Number of events 2 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Cardiac disorders
Myocardial infarction
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Cardiac disorders
Pericardial effusion
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Chylous ascites
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Esophageal fistula
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/194 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Colitis
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Gastritis
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Vascular disorders
Hypertension
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Vascular disorders
Thromboembolic event
|
2.1%
4/194 • Number of events 4 • 6 months
|
1.0%
1/96 • Number of events 2 • 6 months
|
|
Vascular disorders
Hematoma
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
Other adverse events
| Measure |
NPWT - Negative Pressure Wound Therapy
n=194 participants at risk
Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
Negative Pressure Wound Therapy: Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
|
Standard of Care Wound Therapy
n=96 participants at risk
Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
|
|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Cardiac disorders
Myocardial infarction
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
7/194 • Number of events 7 • 6 months
|
4.2%
4/96 • Number of events 4 • 6 months
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
2/194 • Number of events 2 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Hematuria
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Vascular disorders
Thromboembolic event
|
3.1%
6/194 • Number of events 6 • 6 months
|
3.1%
3/96 • Number of events 3 • 6 months
|
|
Vascular disorders
Hypotension
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
General disorders
Fever
|
1.0%
2/194 • Number of events 2 • 6 months
|
3.1%
3/96 • Number of events 4 • 6 months
|
|
General disorders
Flu like symptoms
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
General disorders
Gait disturbance
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
2/194 • Number of events 2 • 6 months
|
3.1%
3/96 • Number of events 4 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
1.5%
3/194 • Number of events 5 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/194 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Perforation bile duct
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Investigations
Blood bilirubin increased
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Investigations
Creatinine increased
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Investigations
Investigations - Other, specify
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Psychiatric disorders
Delirium
|
0.52%
1/194 • Number of events 1 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Confusion
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Nervous system disorders
Syncope
|
0.52%
1/194 • Number of events 1 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Peritoneal infection
|
0.52%
1/194 • Number of events 1 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Infections and infestations
Pleural infection
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Abdominal infection
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Bacteremia
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Bronchial infection
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Pancreas infection
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Skin infection
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.1%
4/194 • Number of events 4 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
3/194 • Number of events 3 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
3/194 • Number of events 3 • 6 months
|
0.00%
0/96 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.52%
1/194 • Number of events 1 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
6/194 • Number of events 6 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Ileus
|
1.0%
2/194 • Number of events 2 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Chylous ascites
|
0.52%
1/194 • Number of events 1 • 6 months
|
2.1%
2/96 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.0%
2/194 • Number of events 4 • 6 months
|
1.0%
1/96 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
3/194 • Number of events 4 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Enterocolitis
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Colitis
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Esophageal fistula
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastroparesis
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/194 • 6 months
|
1.0%
1/96 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.52%
1/194 • Number of events 1 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Wound infection
|
2.1%
4/194 • Number of events 5 • 6 months
|
3.1%
3/96 • Number of events 3 • 6 months
|
|
Infections and infestations
Sepsis
|
1.0%
2/194 • Number of events 2 • 6 months
|
2.1%
2/96 • Number of events 3 • 6 months
|
|
Infections and infestations
Enterocolitis infectious
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.0%
2/194 • Number of events 2 • 6 months
|
0.00%
0/96 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place