Trial Outcomes & Findings for Efficacy and Safety of the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy (NCT NCT00749749)
NCT ID: NCT00749749
Last Updated: 2020-11-04
Results Overview
Higher value means worse outcome - Higher number reflects a need for more analgesia - For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. Measurement recorded in total Morphine Milligrams
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
0 to 24 hours postoperatively
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
Bupivacaine Collagen Sponge
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
|
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy
Baseline characteristics by cohort
| Measure |
Bupivacaine Collagen Sponge
n=14 Participants
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
|
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
n=13 Participants
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 11.50 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 41.0 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 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
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 hours postoperativelyPopulation: Intent-to-Treat Population
Higher value means worse outcome - Higher number reflects a need for more analgesia - For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. Measurement recorded in total Morphine Milligrams
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=14 Participants
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
|
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
n=13 Participants
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
|
|---|---|---|
|
Total Amount of Opioid Rescue Analgesia Used
|
46.85 Morphine Milligrams
Standard Deviation 21.57
|
67.03 Morphine Milligrams
Standard Deviation 32.416
|
SECONDARY outcome
Timeframe: 0 to 48 hours postoperativelyPopulation: ITT population
Higher score means worse outcome - Higher number means more Analgesia was needed. For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. After 24 hours, patients were offered hydrocodone/acetaminophen (maximum could not exceed 8 tablets per 24 hours of the 5/500 mg tablets \[40 mg hydrocodone and 4000 mg acetaminophen\]) or similar medication as determined by the Investigator for pain until discharge. If oral medication was insufficient for control of pain, IM or IV morphine could be administered.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=14 Participants
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
|
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
n=13 Participants
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
|
|---|---|---|
|
Total Amount of Opioid Rescue Analgesia Used
|
55.43 Morphine equivalents
Standard Deviation 22.770
|
74.85 Morphine equivalents
Standard Deviation 35.381
|
SECONDARY outcome
Timeframe: 0 to 96 hours postoperativelyPopulation: ITT Population
Higher score means worse outcome. Higher number means more Analgesia was needed. For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. After 24 hours, patients were offered hydrocodone/acetaminophen (maximum could not exceed 8 tablets per 24 hours of the 5/500 mg tablets \[40 mg hydrocodone and 4000 mg acetaminophen\]) or similar medication as determined by the Investigator for pain until discharge. If oral medication was insufficient for control of pain, IM or IV morphine could be administered.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=14 Participants
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
|
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
n=13 Participants
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
|
|---|---|---|
|
The Total Amount of Opioid Rescue Analgesia Used
|
67.87 Morphine equivalents
Standard Deviation 28.175
|
90.77 Morphine equivalents
Standard Deviation 46.114
|
SECONDARY outcome
Timeframe: 0 to 72 HoursPopulation: ITT population
Higher score means worse outcome. Higher number means more Analgesia was needed. For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. After 24 hours, patients were offered hydrocodone/acetaminophen (maximum could not exceed 8 tablets per 24 hours of the 5/500 mg tablets \[40 mg hydrocodone and 4000 mg acetaminophen\]) or similar medication as determined by the Investigator for pain until discharge. If oral medication was insufficient for control of pain, IM or IV morphine could be administered.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=14 Participants
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
|
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
n=13 Participants
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
|
|---|---|---|
|
Total Use of Opioid Rescue Analgesia (mg) Over 0 to 72 Hours
|
61.98 Morphine equivalents
Standard Deviation 25.27
|
85.36 Morphine equivalents
Standard Deviation 41.887
|
SECONDARY outcome
Timeframe: 0 to 72 hoursPopulation: Intent-to-Treat Population
Higher score has a better outcome
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=14 Participants
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
|
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
n=13 Participants
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
|
|---|---|---|
|
Time to First Use of Opioid Rescue Analgesia
|
0.78 Hours
Interval 0.43 to 1.02
|
0.57 Hours
Interval 0.33 to 0.58
|
SECONDARY outcome
Timeframe: Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96Population: ITT population
For the VAS assessment, patients measured their pain intensity at rest using a horizontal 100-mm VAS scale labeled as follows: No Pain (0 mm) as the left anchor and Worst Pain Imaginable (100 mm) as the right anchor.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=14 Participants
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
|
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
n=13 Participants
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
|
|---|---|---|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 1.0
|
75.2 units on a scale
Standard Deviation 21.32
|
74.5 units on a scale
Standard Deviation 22.75
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 1.5
|
66.3 units on a scale
Standard Deviation 24.96
|
66.5 units on a scale
Standard Deviation 28.65
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 2
|
61.5 units on a scale
Standard Deviation 26.92
|
68.6 units on a scale
Standard Deviation 26.52
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 3
|
52.2 units on a scale
Standard Deviation 21.71
|
60.9 units on a scale
Standard Deviation 29.85
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 6
|
49.9 units on a scale
Standard Deviation 32.15
|
45.8 units on a scale
Standard Deviation 24.49
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 9
|
38.1 units on a scale
Standard Deviation 29.37
|
35.8 units on a scale
Standard Deviation 24.48
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 12
|
43.6 units on a scale
Standard Deviation 33.33
|
38.9 units on a scale
Standard Deviation 25.87
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 18
|
44.5 units on a scale
Standard Deviation 29.46
|
50.7 units on a scale
Standard Deviation 30.59
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 24
|
49.3 units on a scale
Standard Deviation 32.63
|
40.3 units on a scale
Standard Deviation 26.04
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 36
|
47.0 units on a scale
Standard Deviation 32.11
|
27.8 units on a scale
Standard Deviation 20.27
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 48
|
34.2 units on a scale
Standard Deviation 27.31
|
27.9 units on a scale
Standard Deviation 19.67
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 72
|
27.4 units on a scale
Standard Deviation 24.79
|
34.6 units on a scale
Standard Deviation 30.00
|
|
VAS Pain Intensity Scores Over Time AT REST
Hour 96
|
27.1 units on a scale
Standard Deviation 23.70
|
19.1 units on a scale
Standard Deviation 28.24
|
SECONDARY outcome
Timeframe: Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96Population: Intent-to-Treat Population
For the VAS assessment, patients measured their pain intensity after aggravated movement (cough) using a horizontal 100-mm VAS scale labeled as follows: No Pain (0 mm) as the left anchor and Worst Pain Imaginable (100 mm) as the right anchor.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=14 Participants
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
|
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
n=13 Participants
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
|
|---|---|---|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 1
|
84.4 units on a scale
Standard Deviation 21.41
|
86.1 units on a scale
Standard Deviation 21.72
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 1.5
|
76.5 units on a scale
Standard Deviation 24.54
|
79.8 units on a scale
Standard Deviation 25.33
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 2.0
|
73.8 units on a scale
Standard Deviation 26.25
|
84.6 units on a scale
Standard Deviation 24.19
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 3.0
|
62.1 units on a scale
Standard Deviation 26.52
|
77.1 units on a scale
Standard Deviation 31.40
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
hour 6.0
|
61.9 units on a scale
Standard Deviation 33.51
|
65.8 units on a scale
Standard Deviation 28.50
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 9.0
|
51.5 units on a scale
Standard Deviation 33.07
|
52.5 units on a scale
Standard Deviation 28.08
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 12
|
43.6 units on a scale
Standard Deviation 33.33
|
38.9 units on a scale
Standard Deviation 25.87
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 18
|
44.5 units on a scale
Standard Deviation 29.46
|
50.7 units on a scale
Standard Deviation 30.59
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 24
|
49.3 units on a scale
Standard Deviation 32.63
|
40.3 units on a scale
Standard Deviation 26.04
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 36
|
47.0 units on a scale
Standard Deviation 32.11
|
27.8 units on a scale
Standard Deviation 20.27
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 48
|
34.2 units on a scale
Standard Deviation 27.31
|
27.9 units on a scale
Standard Deviation 19.67
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 72
|
27.4 units on a scale
Standard Deviation 24.79
|
34.6 units on a scale
Standard Deviation 30.00
|
|
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Hour 96
|
27.1 units on a scale
Standard Deviation 23.70
|
19.1 units on a scale
Standard Deviation 28.24
|
Adverse Events
Bupivacaine Collagen Sponge
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupivacaine Collagen Sponge
n=14 participants at risk
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
|
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System
n=13 participants at risk
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Number of events 2 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
0.00%
0/13 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
2/14 • Number of events 2 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
0.00%
0/13 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
15.4%
2/13 • Number of events 2 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
15.4%
2/13 • Number of events 2 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
7.7%
1/13 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • Number of events 2 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
0.00%
0/13 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
7.7%
1/13 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
7.7%
1/13 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
General disorders
Oedema peripheral
|
0.00%
0/14 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
7.7%
1/13 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
|
General disorders
Chills
|
0.00%
0/14 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
7.7%
1/13 • Number of events 1 • Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.
|
Additional Information
Innocoll
Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
Phone: 484-406-5211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place