Trial Outcomes & Findings for A Study of Fibrocaps™ in Surgical Bleeding (NCT NCT01527357)
NCT ID: NCT01527357
Last Updated: 2019-12-18
Results Overview
The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
721 participants
Primary outcome timeframe
Within 5 minutes
Results posted on
2019-12-18
Participant Flow
Participants were enrolled from May 2012 to April 2013 at 57 investigative sites (United States, n = 28; United Kingdom, n = 12; The Netherlands, n = 11; and Belgium, n = 6), and were randomized 2:1 to receive treatment with Fibrocaps plus gelatin sponge or gelatin sponge alone.
After screening, 719 eligible participants had surgery in 1 of 4 surgical indications (i.e., spinal, hepatic, vascular, or soft tissue dissection) on Day 1 according to local standard practice, and received treatment with the investigational product assigned.
Participant milestones
| Measure |
Fibrocaps + Gelatin Sponge
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
Single application of gelatin sponge alone.
|
|---|---|---|
|
Overall Study
STARTED
|
482
|
239
|
|
Overall Study
Efficacy Population
|
480
|
239
|
|
Overall Study
COMPLETED
|
465
|
230
|
|
Overall Study
NOT COMPLETED
|
17
|
9
|
Reasons for withdrawal
| Measure |
Fibrocaps + Gelatin Sponge
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
Single application of gelatin sponge alone.
|
|---|---|---|
|
Overall Study
Death
|
8
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
|
Overall Study
Withdrew Consent
|
1
|
1
|
|
Overall Study
Non-compliance
|
0
|
1
|
|
Overall Study
No Day 29 Visit
|
0
|
1
|
|
Overall Study
Did Not Receive Treatment
|
2
|
0
|
Baseline Characteristics
A Study of Fibrocaps™ in Surgical Bleeding
Baseline characteristics by cohort
| Measure |
Fibrocaps + Gelatin Sponge
n=482 Participants
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=239 Participants
Single application of gelatin sponge alone.
|
Total
n=721 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 14.44 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 14.12 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 14.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
214 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
268 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
392 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 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
|
42 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
422 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
632 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
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 5 minutesPopulation: Efficacy population consists of all participants who were randomized, received study treatment, and had a TTH assessment. Number analyzed is the number of participants in the efficacy population who receive each type of surgery.
The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Outcome measures
| Measure |
Fibrocaps + Gelatin Sponge
n=122 Participants
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=61 Participants
Single application of gelatin sponge alone.
|
|---|---|---|
|
Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery
|
1.0 minutes
Interval 0.5 to 1.5
|
2.5 minutes
Interval 1.5 to 4.0
|
PRIMARY outcome
Timeframe: Within 5 minutesPopulation: Efficacy population
The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Outcome measures
| Measure |
Fibrocaps + Gelatin Sponge
n=117 Participants
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=58 Participants
Single application of gelatin sponge alone.
|
|---|---|---|
|
Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery
|
2.0 minutes
Interval 1.5 to 2.5
|
4.0 minutes
Interval 3.0 to 5.0
|
PRIMARY outcome
Timeframe: Within 5 minutesPopulation: Efficacy population
The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Outcome measures
| Measure |
Fibrocaps + Gelatin Sponge
n=119 Participants
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=61 Participants
Single application of gelatin sponge alone.
|
|---|---|---|
|
Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection
|
1.0 minutes
Interval 1.0 to 1.5
|
2.0 minutes
Interval 1.5 to 2.5
|
PRIMARY outcome
Timeframe: Within 5 minutesPopulation: Efficacy population
The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Outcome measures
| Measure |
Fibrocaps + Gelatin Sponge
n=122 Participants
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=59 Participants
Single application of gelatin sponge alone.
|
|---|---|---|
|
Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection
|
1.5 minutes
Interval 1.0 to 1.5
|
2.5 minutes
Interval 2.0 to 3.5
|
SECONDARY outcome
Timeframe: Within 5 minutesPopulation: Efficacy population. Number analyzed is the number of participants with data available for analysis in each surgery type.
Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.
Outcome measures
| Measure |
Fibrocaps + Gelatin Sponge
n=480 Participants
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=239 Participants
Single application of gelatin sponge alone.
|
|---|---|---|
|
Restricted Mean TTH
Vascular Surgery
|
2.4 minutes
Standard Error 0.14
|
3.5 minutes
Standard Error 0.2
|
|
Restricted Mean TTH
Hepatic Resection
|
1.5 minutes
Standard Error 0.09
|
2.5 minutes
Standard Error 0.21
|
|
Restricted Mean TTH
Soft Tissue Dissection
|
1.5 minutes
Standard Error 0.09
|
3.1 minutes
Standard Error 0.19
|
|
Restricted Mean TTH
Spinal Surgery
|
1.2 minutes
Standard Error 0.08
|
2.7 minutes
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Within 29 daysPopulation: Safety population, defined as all participants who were randomized and received study treatment.
An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is any adverse event reported on the case report form that occurs after start of treatment or any adverse event with a missing start date.
Outcome measures
| Measure |
Fibrocaps + Gelatin Sponge
n=480 Participants
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=239 Participants
Single application of gelatin sponge alone.
|
|---|---|---|
|
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
|
426 Participants
|
214 Participants
|
SECONDARY outcome
Timeframe: At 5 minutesPopulation: Efficacy population
If hemostasis is not achieved within 5 minutes, the treatment is considered to have failed, and the surgeon is to implement additional hemostatic measures.
Outcome measures
| Measure |
Fibrocaps + Gelatin Sponge
n=480 Participants
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=239 Participants
Single application of gelatin sponge alone.
|
|---|---|---|
|
Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Within 29 daysPopulation: Efficacy population
Red blood cells are defined as including World Health Organization (WHO) DRUG terms of "Blood cells, packed human", "Blood, whole", "Red blood cells", "Red blood cells, concentrated" and "Red blood cells, leucocyte depleted".
Outcome measures
| Measure |
Fibrocaps + Gelatin Sponge
n=480 Participants
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=239 Participants
Single application of gelatin sponge alone.
|
|---|---|---|
|
Number of Participants Who Required Red Blood Cells
|
40 Participants
|
22 Participants
|
Adverse Events
Fibrocaps + Gelatin Sponge
Serious events: 81 serious events
Other events: 426 other events
Deaths: 8 deaths
Gelatin Sponge
Serious events: 29 serious events
Other events: 214 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Fibrocaps + Gelatin Sponge
n=480 participants at risk
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=239 participants at risk
Single application of gelatin sponge alone.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.83%
4/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.84%
2/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Abdominal abscess
|
0.83%
4/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Postoperative wound infection
|
0.83%
4/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Sepsis
|
0.62%
3/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Wound infection
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Abdominal sepsis
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Cellulitis
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Infectious peritonitis
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Liver abscess
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Lung infection
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Septic shock
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Subcutaneous abscess
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Urinary tract infection
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Infections and infestations
Urosepsis
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.62%
3/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.84%
2/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.84%
2/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Small-for-size liver syndrome
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Fall
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Gastrointestinal disorder postoperative
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Pancreatic leak
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Ileus
|
0.62%
3/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.84%
2/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Gastroduodenal haemorrhage
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Small intestinal ulcer haemorrhage
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
1.3%
3/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Vascular disorders
Lymphorrhoea
|
0.62%
3/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Vascular disorders
Peripheral ischaemia
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Vascular disorders
Deep vein thrombosis
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Vascular disorders
Hypotension
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Vascular disorders
Vena cava thrombosis
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Cardiac disorders
Atrial fibrillation
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Cardiac disorders
Cardiac arrest
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Cardiac disorders
Myocardial infarction
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
General disorders
Cardiac death
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
General disorders
Chest pain
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
General disorders
Death
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
General disorders
Hernia obstructive
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
General disorders
Malaise
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
General disorders
Pyrexia
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
General disorders
Unintentional medical device removal by patient
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.83%
4/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.42%
2/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Nervous system disorders
Cerebral infarction
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Nervous system disorders
Paraplegia
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Investigations
Hepatitis C antibody positive
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.42%
1/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Psychiatric disorders
Mental status changes
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Renal and urinary disorders
Renal failure acute
|
0.21%
1/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
0.00%
0/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
Other adverse events
| Measure |
Fibrocaps + Gelatin Sponge
n=480 participants at risk
Single application of Fibrocaps plus gelatin sponge.
|
Gelatin Sponge
n=239 participants at risk
Single application of gelatin sponge alone.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural Pain
|
53.5%
257/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
56.1%
134/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
120/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
20.1%
48/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
72/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
13.0%
31/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
13.1%
63/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
13.4%
32/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Vascular disorders
Hypotension
|
7.9%
38/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
6.7%
16/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
33/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
7.1%
17/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Psychiatric disorders
Insomnia
|
8.5%
41/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
4.2%
10/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
General disorders
Pyrexia
|
7.7%
37/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
4.6%
11/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
33/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
3.3%
8/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Vascular disorders
Hypertension
|
5.2%
25/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
4.2%
10/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
26/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
5.0%
12/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
4.6%
22/480 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
3.3%
8/239 • From time of surgery (Day 1) through Day 29 (End of Study)
Safety population, defined as all participants who were randomized and received study treatment. All treatment-emergent serious adverse events are listed, whether or not they are related to study product.
|
Additional Information
Medical Information Call Center
Mallinckrodt Pharmaceuticals
Phone: 800-556-3314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place