Trial Outcomes & Findings for The Fibrin Patch Soft Tissue Study (NCT NCT00658723)
NCT ID: NCT00658723
Last Updated: 2014-09-11
Results Overview
Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
141 participants
Primary outcome timeframe
Intra-operative
Results posted on
2014-09-11
Participant Flow
A total of 11 clinical centers in the US partipcated in the trial enrolled 141 subjects. The first subject randomized: March 26, 2008 and the last subject completed: April 24, 2009
The efficacy results are based on the intent-to-treat (ITT) set, which is based on 90 randomized subjects from the two randomized arms - Fibrin Pad Randomized and SURGICEL(TM) Randomized. The Fibrin Pad Non-randomized arm was used for the safety analysis set.
Participant milestones
| Measure |
Fibrin Pad Randomized
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
|
SURGICEL™ Randomized
SURGICEL™ Absorbable Hemostat
SURGICEL™: Absorbable hemostat
|
Fibrin Pad Non-randomized
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). (Non - Randomized)
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
30
|
51
|
|
Overall Study
COMPLETED
|
56
|
26
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
7
|
Reasons for withdrawal
| Measure |
Fibrin Pad Randomized
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
|
SURGICEL™ Randomized
SURGICEL™ Absorbable Hemostat
SURGICEL™: Absorbable hemostat
|
Fibrin Pad Non-randomized
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). (Non - Randomized)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
|
Overall Study
Death
|
2
|
1
|
4
|
|
Overall Study
Scheduling Issue
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
Baseline Characteristics
The Fibrin Patch Soft Tissue Study
Baseline characteristics by cohort
| Measure |
Fibrin Pad All
n=111 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized \& Non Randomized
|
SURGICEL™ Randomized
n=30 Participants
SURGICEL™ Absorbable Hemostat
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
30 participants
n=7 Participants
|
141 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intra-operativeProportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.
Outcome measures
| Measure |
Fibrin Pad - Randomized
n=60 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
|
SURGICEL
n=30 Participants
SURGICEL™ Absorbable Hemostat
|
Fibrin Pad - Non-Randomized
n=51 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
|
|---|---|---|---|
|
Proportion of Subjects Achieving Hemostatic Success
|
98.3 percentage of success
|
53.3 percentage of success
|
98.0 percentage of success
|
SECONDARY outcome
Timeframe: 10 minutesThe proportion of subjects achieving hemostatic success at 10 minutes following randomization
Outcome measures
| Measure |
Fibrin Pad - Randomized
n=60 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
|
SURGICEL
n=30 Participants
SURGICEL™ Absorbable Hemostat
|
Fibrin Pad - Non-Randomized
n=51 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
|
|---|---|---|---|
|
Proportion of Subjects Achieving Hemostatic Success
|
98.3 percentage of success
|
73.3 percentage of success
|
100.0 percentage of success
|
SECONDARY outcome
Timeframe: Intra-operativeIf hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.
Outcome measures
| Measure |
Fibrin Pad - Randomized
n=60 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
|
SURGICEL
n=30 Participants
SURGICEL™ Absorbable Hemostat
|
Fibrin Pad - Non-Randomized
n=51 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
|
|---|---|---|---|
|
Incidence of Treatment Failures
|
1.7 percentage of treatment failure
|
46.7 percentage of treatment failure
|
2.0 percentage of treatment failure
|
SECONDARY outcome
Timeframe: Intra-operative up to 1 month (+14 days)The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).
Outcome measures
| Measure |
Fibrin Pad - Randomized
n=60 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
|
SURGICEL
n=30 Participants
SURGICEL™ Absorbable Hemostat
|
Fibrin Pad - Non-Randomized
n=51 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
|
|---|---|---|---|
|
Incidence of Adverse Events That Are Potentially Related to Bleeding
|
0 percentage of particpants
|
10 percentage of particpants
|
0 percentage of particpants
|
SECONDARY outcome
Timeframe: Intra-operative up to 1 month (+14 days)The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism
Outcome measures
| Measure |
Fibrin Pad - Randomized
n=60 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
|
SURGICEL
n=30 Participants
SURGICEL™ Absorbable Hemostat
|
Fibrin Pad - Non-Randomized
n=51 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
|
|---|---|---|---|
|
Incidence of Adverse Events That Are Potentially Related to Thrombotic Events
|
1.7 percentage of participants
|
6.7 percentage of participants
|
13.7 percentage of participants
|
SECONDARY outcome
Timeframe: Intra-operative up to 1 month (+14 days)The types of events that were potentially related to transfusion exposure could have include hypocalcemia.
Outcome measures
| Measure |
Fibrin Pad - Randomized
n=60 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
|
SURGICEL
n=30 Participants
SURGICEL™ Absorbable Hemostat
|
Fibrin Pad - Non-Randomized
n=51 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
|
|---|---|---|---|
|
Incidence of Adverse Events Potentially Related to Transfusion Exposure
|
0 percentage of particpants
|
0 percentage of particpants
|
0 percentage of particpants
|
SECONDARY outcome
Timeframe: Intra-operativeThe outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period. In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment.
Outcome measures
| Measure |
Fibrin Pad - Randomized
n=60 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
|
SURGICEL
n=30 Participants
SURGICEL™ Absorbable Hemostat
|
Fibrin Pad - Non-Randomized
n=51 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
|
|---|---|---|---|
|
Incidence of Re-treatment
Total Incidence of Re-treatment
|
1 participants
|
14 participants
|
1 participants
|
|
Incidence of Re-treatment
No hemostasis at 4-minutes and re-treated
|
1 participants
|
12 participants
|
1 participants
|
|
Incidence of Re-treatment
Achieved hemostasis at 4-mins and re-treated
|
0 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 30 days (+14 days)Outcome measures
| Measure |
Fibrin Pad - Randomized
n=111 Participants
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
|
SURGICEL
n=30 Participants
SURGICEL™ Absorbable Hemostat
|
Fibrin Pad - Non-Randomized
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
|
|---|---|---|---|
|
Incidence of Adverse Events
|
94.6 % if participants with atleast one AE
|
90.0 % if participants with atleast one AE
|
—
|
Adverse Events
Fibrin Pad All
Serious events: 40 serious events
Other events: 105 other events
Deaths: 0 deaths
SURGICEL™ Randomized
Serious events: 15 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fibrin Pad All
n=111 participants at risk
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized \& Non Randomized
|
SURGICEL™ Randomized
n=30 participants at risk
SURGICEL™ Absorbable Hemostat
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
1.8%
2/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
GASTROINTESTINAL HYPOMOTILITY
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
ILEUS
|
1.8%
2/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
0.00%
0/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
INTESTINAL INFARCTION
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
LOCALISED INTRAABDOMINAL FLUID COLLECTION
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
NAUSEA
|
1.8%
2/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
OESOPHAGEAL PERFORATION
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
PANCREATIC FISTULA
|
0.00%
0/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
2.7%
3/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
VOMITING
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
General disorders
PYREXIA
|
0.00%
0/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
2.7%
3/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
ABSCESS
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
BRONCHITIS
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
EMPYEMA
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
LIVER ABSCESS
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
PNEUMONIA
|
2.7%
3/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
WOUND INFECTION
|
2.7%
3/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Injury, poisoning and procedural complications
ABDOMINAL WOUND DEHISCENCE
|
0.00%
0/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
1.8%
2/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Injury, poisoning and procedural complications
OPERATIVE HAEMORRHAGE
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Injury, poisoning and procedural complications
PERIPANCREATIC FLUID COLLECTION
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE ILEUS
|
1.8%
2/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
10.0%
3/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.00%
0/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
0.00%
0/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.8%
2/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPLEURAL FISTULA
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.8%
2/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.8%
2/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS EMPHYSEMA
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Vascular disorders
EMBOLISM
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Vascular disorders
HYPOTENSION
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
Other adverse events
| Measure |
Fibrin Pad All
n=111 participants at risk
Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized \& Non Randomized
|
SURGICEL™ Randomized
n=30 participants at risk
SURGICEL™ Absorbable Hemostat
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
17.1%
19/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
23.3%
7/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
11.7%
13/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
16.7%
5/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.6%
4/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Cardiac disorders
TACHYCARDIA
|
14.4%
16/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
13.3%
4/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
CONSTIPATION
|
11.7%
13/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
13.3%
4/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.3%
7/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.7%
3/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
ILEUS
|
9.9%
11/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
13.3%
4/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
NAUSEA
|
41.4%
46/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
46.7%
14/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Gastrointestinal disorders
VOMITING
|
9.9%
11/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
General disorders
CHEST PAIN
|
1.8%
2/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
General disorders
OEDEMA
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
10.0%
3/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
General disorders
PAIN
|
16.2%
18/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
16.7%
5/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
General disorders
PYREXIA
|
19.8%
22/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
40.0%
12/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
2.7%
3/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
10.0%
3/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
PNEUMONIA
|
7.2%
8/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
10.0%
3/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.3%
7/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Infections and infestations
WOUND INFECTION
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Injury, poisoning and procedural complications
OPERATIVE HAEMORRHAGE
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
10.0%
3/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE ILEUS
|
1.8%
2/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
10.0%
3/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
3.6%
4/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
10.0%
3/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Investigations
URINE OUTPUT DECREASED
|
5.4%
6/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
6.3%
7/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
10.0%
3/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
23.4%
26/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
20.0%
6/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
11.7%
13/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
26.7%
8/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
26.1%
29/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
26.7%
8/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
39.6%
44/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
50.0%
15/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
5.4%
6/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
21.6%
24/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
50.0%
15/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
8.1%
9/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.90%
1/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Psychiatric disorders
ANXIETY
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
0.00%
0/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Psychiatric disorders
INSOMNIA
|
7.2%
8/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
16.7%
5/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
18.0%
20/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
20.0%
6/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPLEURAL FISTULA
|
5.4%
6/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
15.3%
17/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
16.7%
5/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
11.7%
13/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Social circumstances
PULMONARY OEDEMA
|
5.4%
6/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
3.3%
1/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Respiratory, thoracic and mediastinal disorders
RHONCHI
|
5.4%
6/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
13.3%
4/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
12.6%
14/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
10.0%
3/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS EMPHYSEMA
|
4.5%
5/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Vascular disorders
HYPERTENSION
|
11.7%
13/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
6.7%
2/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
|
Vascular disorders
HYPOTENSION
|
11.7%
13/111 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
13.3%
4/30 • 30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
|
Additional Information
Jonathan Batiller, Director Clinical Development
ETHICON, Inc.
Phone: 908-218-2819
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60