Trial Outcomes & Findings for A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501 (NCT NCT01509638)
NCT ID: NCT01509638
Last Updated: 2014-03-06
Results Overview
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
47 participants
Primary outcome timeframe
Wound closure to time hospital discharge order is written or Day 30, whichever is sooner
Results posted on
2014-03-06
Participant Flow
23 patients in Group 1 and 25 patients in Group 2 were enrolled. 22 patients from Group 1 and 23 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Participant milestones
| Measure |
Group 1 Standard of Care
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
26
|
|
Overall Study
COMPLETED
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501
Baseline characteristics by cohort
| Measure |
Group 1 Standard of Care
n=22 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=25 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 17.87 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 14.53 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 16.01 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is soonerPopulation: 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Outcome measures
| Measure |
Group 1 Standard of Care
n=20 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=23 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Total Opioid Burden
|
67.7 mg morphine equivalent
Standard Deviation 46.64
|
38.41 mg morphine equivalent
Standard Deviation 45.85
|
PRIMARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.
Outcome measures
| Measure |
Group 1 Standard of Care
n=20 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=23 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Health Economic Benefits
|
7284.63 dollars
Standard Deviation 3577.42
|
7010.16 dollars
Standard Deviation 2709.56
|
PRIMARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
Outcome measures
| Measure |
Group 1 Standard of Care
n=20 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=23 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Health Economic Benefit
|
4 days
Interval 2.0 to 7.0
|
3 days
Interval 1.0 to 15.0
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
Outcome measures
| Measure |
Group 1 Standard of Care
n=20 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=23 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Incidence of Opioid-related Adverse Events
|
0.1 number of events
Standard Deviation 0.22
|
0.1 number of events
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Responses to one question pertaining to patient satisfaction with postsurgical analgesia
Outcome measures
| Measure |
Group 1 Standard of Care
n=20 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=23 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Patient Satisfaction With Postsurgical Analgesia
Extremely Satisfied
|
8 participants
|
11 participants
|
|
Patient Satisfaction With Postsurgical Analgesia
Satisified
|
7 participants
|
9 participants
|
|
Patient Satisfaction With Postsurgical Analgesia
Neither Satisfied nor Dissatisfied
|
1 participants
|
2 participants
|
|
Patient Satisfaction With Postsurgical Analgesia
Dissatisfied
|
0 participants
|
1 participants
|
|
Patient Satisfaction With Postsurgical Analgesia
Not Reported
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Yes, if patient discharged from hospital for at least 3 days; no, if patient not discharged from hospital for at least 3 day; not reported, if applicable.
Outcome measures
| Measure |
Group 1 Standard of Care
n=20 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=23 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Patient Discharged From Hospital for at Least 3 Days
|
16 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable
Outcome measures
| Measure |
Group 1 Standard of Care
n=20 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=23 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Patient Made Unplanned Visit(s) With Any Healthcare Providers
|
2 participants who answered yes
|
4 participants who answered yes
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable.
Outcome measures
| Measure |
Group 1 Standard of Care
n=20 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=23 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery
|
5 participants who answered yes
|
2 participants who answered yes
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable
Outcome measures
| Measure |
Group 1 Standard of Care
n=20 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=23 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Experienced Health Problems or Changes in Health Since Hospital Discharge
|
4 participants who answered yes
|
5 participants who answered yes
|
SECONDARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)
Time in hours to first opioid administration
Outcome measures
| Measure |
Group 1 Standard of Care
n=20 Participants
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=23 Participants
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Time to First Opioid Administration
|
0.7 hours
Interval 0.3 to 3.6
|
1.1 hours
Interval 0.3 to 71.0
|
Adverse Events
Group 1 Standard of Care
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 2 EXPAREL
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 Standard of Care
n=22 participants at risk
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=25 participants at risk
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Immune system disorders
Systemic inflammatory response syndrome
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Injury, poisoning and procedural complications
Anastomatic complications
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
Other adverse events
| Measure |
Group 1 Standard of Care
n=22 participants at risk
IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump
Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
|
Group 2 EXPAREL
n=25 participants at risk
bupivacaine liposome injectable suspension.
Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
3/22 • Number of events 3 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
12.0%
3/25 • Number of events 3 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Gastrointestinal disorders
Pyoderma gangrinosum
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
General disorders
Edema peripheral
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Infections and infestations
Wound infection
|
9.1%
2/22 • Number of events 2 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Injury, poisoning and procedural complications
Postprocedural hemorrhage
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
8.0%
2/25 • Number of events 2 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
1/22 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
0.00%
0/25 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/22 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
4.0%
1/25 • Number of events 1 • 30 days post surgery
Normal systematic assessment of adverse events. 22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place