Trial Outcomes & Findings for PeriOperative ISchemic Evaluation-2 Trial (NCT NCT01082874)
NCT ID: NCT01082874
Last Updated: 2016-08-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
10010 participants
Primary outcome timeframe
30 days
Results posted on
2016-08-25
Participant Flow
Participant milestones
| Measure |
Active Clonidine and Active ASA
Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Active Clonidine and Placebo ASA
Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Placebo Clonidine and Active ASA
Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Placebo Clonidine and Placebo ASA
Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2499
|
2510
|
2499
|
2502
|
|
Overall Study
COMPLETED
|
2488
|
2498
|
2488
|
2489
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
11
|
13
|
Reasons for withdrawal
| Measure |
Active Clonidine and Active ASA
Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Active Clonidine and Placebo ASA
Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Placebo Clonidine and Active ASA
Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Placebo Clonidine and Placebo ASA
Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
10
|
6
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
5
|
3
|
Baseline Characteristics
PeriOperative ISchemic Evaluation-2 Trial
Baseline characteristics by cohort
| Measure |
Active Clonidine and Active ASA
n=2499 Participants
Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Active Clonidine and Placebo ASA
n=2510 Participants
Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Placebo Clonidine and Active ASA
n=2499 Participants
Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Placebo Clonidine and Placebo ASA
n=2502 Participants
Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Total
n=10010 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
873 Participants
n=99 Participants
|
836 Participants
n=107 Participants
|
836 Participants
n=206 Participants
|
866 Participants
n=7 Participants
|
3411 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1626 Participants
n=99 Participants
|
1674 Participants
n=107 Participants
|
1663 Participants
n=206 Participants
|
1636 Participants
n=7 Participants
|
6599 Participants
n=31 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
68.6 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
68.7 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
68.5 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
68.6 years
STANDARD_DEVIATION 10.3 • n=31 Participants
|
|
Gender
Female
|
1212 participants
n=99 Participants
|
1164 participants
n=107 Participants
|
1188 participants
n=206 Participants
|
1160 participants
n=7 Participants
|
4724 participants
n=31 Participants
|
|
Gender
Male
|
1287 participants
n=99 Participants
|
1346 participants
n=107 Participants
|
1310 participants
n=206 Participants
|
1340 participants
n=7 Participants
|
5283 participants
n=31 Participants
|
|
Region of Enrollment
Colombia
|
162 participants
n=99 Participants
|
161 participants
n=107 Participants
|
164 participants
n=206 Participants
|
162 participants
n=7 Participants
|
649 participants
n=31 Participants
|
|
Region of Enrollment
Argentina
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
11 participants
n=31 Participants
|
|
Region of Enrollment
Hong Kong
|
69 participants
n=99 Participants
|
70 participants
n=107 Participants
|
69 participants
n=206 Participants
|
68 participants
n=7 Participants
|
276 participants
n=31 Participants
|
|
Region of Enrollment
United States
|
443 participants
n=99 Participants
|
440 participants
n=107 Participants
|
437 participants
n=206 Participants
|
440 participants
n=7 Participants
|
1760 participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
22 participants
n=99 Participants
|
22 participants
n=107 Participants
|
22 participants
n=206 Participants
|
20 participants
n=7 Participants
|
86 participants
n=31 Participants
|
|
Region of Enrollment
Malaysia
|
30 participants
n=99 Participants
|
28 participants
n=107 Participants
|
30 participants
n=206 Participants
|
32 participants
n=7 Participants
|
120 participants
n=31 Participants
|
|
Region of Enrollment
Switzerland
|
24 participants
n=99 Participants
|
24 participants
n=107 Participants
|
25 participants
n=206 Participants
|
23 participants
n=7 Participants
|
96 participants
n=31 Participants
|
|
Region of Enrollment
India
|
149 participants
n=99 Participants
|
149 participants
n=107 Participants
|
151 participants
n=206 Participants
|
146 participants
n=7 Participants
|
595 participants
n=31 Participants
|
|
Region of Enrollment
Spain
|
133 participants
n=99 Participants
|
139 participants
n=107 Participants
|
131 participants
n=206 Participants
|
135 participants
n=7 Participants
|
538 participants
n=31 Participants
|
|
Region of Enrollment
New Zealand
|
14 participants
n=99 Participants
|
11 participants
n=107 Participants
|
11 participants
n=206 Participants
|
10 participants
n=7 Participants
|
46 participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
875 participants
n=99 Participants
|
878 participants
n=107 Participants
|
872 participants
n=206 Participants
|
873 participants
n=7 Participants
|
3498 participants
n=31 Participants
|
|
Region of Enrollment
Austria
|
44 participants
n=99 Participants
|
44 participants
n=107 Participants
|
42 participants
n=206 Participants
|
46 participants
n=7 Participants
|
176 participants
n=31 Participants
|
|
Region of Enrollment
Pakistan
|
43 participants
n=99 Participants
|
44 participants
n=107 Participants
|
44 participants
n=206 Participants
|
44 participants
n=7 Participants
|
175 participants
n=31 Participants
|
|
Region of Enrollment
Belgium
|
44 participants
n=99 Participants
|
47 participants
n=107 Participants
|
46 participants
n=206 Participants
|
47 participants
n=7 Participants
|
184 participants
n=31 Participants
|
|
Region of Enrollment
Brazil
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
16 participants
n=206 Participants
|
16 participants
n=7 Participants
|
57 participants
n=31 Participants
|
|
Region of Enrollment
Denmark
|
80 participants
n=99 Participants
|
80 participants
n=107 Participants
|
80 participants
n=206 Participants
|
81 participants
n=7 Participants
|
321 participants
n=31 Participants
|
|
Region of Enrollment
Italy
|
39 participants
n=99 Participants
|
39 participants
n=107 Participants
|
38 participants
n=206 Participants
|
38 participants
n=7 Participants
|
154 participants
n=31 Participants
|
|
Region of Enrollment
South Africa
|
87 participants
n=99 Participants
|
87 participants
n=107 Participants
|
89 participants
n=206 Participants
|
90 participants
n=7 Participants
|
353 participants
n=31 Participants
|
|
Region of Enrollment
Australia
|
119 participants
n=99 Participants
|
120 participants
n=107 Participants
|
113 participants
n=206 Participants
|
118 participants
n=7 Participants
|
470 participants
n=31 Participants
|
|
Region of Enrollment
Chile
|
38 participants
n=99 Participants
|
38 participants
n=107 Participants
|
38 participants
n=206 Participants
|
39 participants
n=7 Participants
|
153 participants
n=31 Participants
|
|
Region of Enrollment
France
|
21 participants
n=99 Participants
|
24 participants
n=107 Participants
|
24 participants
n=206 Participants
|
20 participants
n=7 Participants
|
89 participants
n=31 Participants
|
|
Region of Enrollment
Peru
|
41 participants
n=99 Participants
|
44 participants
n=107 Participants
|
43 participants
n=206 Participants
|
44 participants
n=7 Participants
|
172 participants
n=31 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
11 participants
n=206 Participants
|
7 participants
n=7 Participants
|
31 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Active Clonidine and Active ASA
n=2499 Participants
Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Active Clonidine and Placebo ASA
n=2510 Participants
Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Placebo Clonidine and Active ASA
n=2499 Participants
Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Placebo Clonidine and Placebo ASA
n=2502 Participants
Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
|---|---|---|---|---|
|
Composite of All-cause Mortality and Nonfatal MI
|
173 participants
|
194 participants
|
178 participants
|
161 participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysAll-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, amputation, peripheral arterial thrombosis, infection/sepsis, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysComposite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysStroke, congestive heart failure, life-threatening bleeding, and major bleeding.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysStroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearAll-cause mortality, nonfatal MI, and nonfatal stroke.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearAll cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, stroke, pulmonary emboli, deep venous thrombosis, amputation, peripheral arterial thrombosis, new diagnosis of cancer, diagnosis of recurrent cancer and rehospitalization for vascular reason.
Outcome measures
Outcome data not reported
Adverse Events
Active Clonidine and Active ASA
Serious events: 46 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Clonidine and Placebo ASA
Serious events: 52 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Clonidine and Active ASA
Serious events: 45 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Clonidine and Placebo ASA
Serious events: 39 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Clonidine and Active ASA
n=2499 participants at risk
Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Active Clonidine and Placebo ASA
n=2510 participants at risk
Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Placebo Clonidine and Active ASA
n=2499 participants at risk
Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
Placebo Clonidine and Placebo ASA
n=2502 participants at risk
Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Blood and lymphatic system disorders
Dissemianted intravascular coagulation
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/2499
|
0.00%
0/2510
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2502
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Cardiac disorders
Sinus Arrest
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Cardiac disorders
Tachy Arrythymia
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Eye disorders
Open Angle Glaucoma
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Enterovesicle Fistula
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Gastrointestinal disorders
GI Hemmorhage
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Gastrointestinal disorders
Hernial Eventration
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/2499
|
0.12%
3/2510 • Number of events 3
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Intestinal Dilatation
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Intestinal Fistuala
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Intestinal Ischemia
|
0.08%
2/2499 • Number of events 2
|
0.04%
1/2510 • Number of events 1
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Mesenteric Vein Thrombosis
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Gastrointestinal disorders
Pneumoretroperitonium
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Rectum hemorrhage
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Samll Intestinal Obstruction
|
0.04%
1/2499 • Number of events 1
|
0.12%
3/2510 • Number of events 3
|
0.04%
1/2499 • Number of events 1
|
0.04%
1/2502 • Number of events 1
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.08%
2/2499 • Number of events 2
|
0.04%
1/2502 • Number of events 1
|
|
General disorders
Device Dislocation
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.04%
1/2502 • Number of events 1
|
|
General disorders
Gait disturbance
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
General disorders
Impaired Healing
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
General disorders
Multi-organ Failure
|
0.08%
2/2499 • Number of events 2
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
General disorders
Pain
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
General disorders
Pyrexia
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Hepatobiliary disorders
Cirrhosis Alcoholic
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Hepatobiliary disorders
Ischemic Hepatitis
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehisence
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Anastomotic Leak
|
0.04%
1/2499 • Number of events 1
|
0.12%
3/2510 • Number of events 3
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bladder Injury
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Endotrachial Intubation complication
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Fascial Rupture
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Gastrointestinal Anastomotic Leak
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Necrosis
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Humerous Fracture
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Incision Site Hemorrhage
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.08%
2/2499 • Number of events 2
|
0.04%
1/2502 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lymphatic Duct Injury
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pancreatic leak
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2510
|
0.12%
3/2499 • Number of events 3
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Postoperative Thoracic Procedure Complication
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subcutaneous Hematoma
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Injury, poisoning and procedural complications
Subdural Hemorrhage
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound Evisceration
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.08%
2/2502 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound Hematoma
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Investigations
Blood Pressure Systolic Increase
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Investigations
Hemoglobin decrease
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Investigations
Internatinal Normalized Ratio Increased
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Investigations
Liver Functin Test Abnormal
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Investigations
Thoracic Cavity Drainage test Abnormal
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
b-Cell Lymphoma
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine Carcinoma Metatastic
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Nervous system disorders
Cognitive Disorder
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Nervous system disorders
Loss of Consciousness
|
0.04%
1/2499 • Number of events 1
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Nervous system disorders
Peroneal Nerve Palsy
|
0.04%
1/2499 • Number of events 1
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Nervous system disorders
Pre-syncope
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Nervous system disorders
Syncope
|
0.04%
1/2499 • Number of events 1
|
0.04%
1/2510 • Number of events 1
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2502
|
|
Nervous system disorders
TIA
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Nervous system disorders
Vasculitis Cerebral
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Psychiatric disorders
Confusinal State
|
0.00%
0/2499
|
0.08%
2/2510 • Number of events 2
|
0.00%
0/2499
|
0.12%
3/2502 • Number of events 3
|
|
Psychiatric disorders
Dilirium
|
0.04%
1/2499 • Number of events 1
|
0.12%
3/2510 • Number of events 3
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Psychiatric disorders
Emotional Distress
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Renal and urinary disorders
Acute Pre-renal Failure
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Renal and urinary disorders
Hematuria
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Renal and urinary disorders
Pelvic-UretericObstruction
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Renal and urinary disorders
Renal Cyst Rupture
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Renal and urinary disorders
Renal Failure
|
0.04%
1/2499 • Number of events 1
|
0.08%
2/2510 • Number of events 2
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.08%
2/2499 • Number of events 2
|
0.16%
4/2502 • Number of events 4
|
|
Renal and urinary disorders
Renal Ischemia
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Renal and urinary disorders
Urinary retention
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Respiratory, thoracic and mediastinal disorders
Actue Respiratory Distress syndrome
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Broncho Spasm
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.08%
2/2499 • Number of events 2
|
0.08%
2/2502 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Respiratory, thoracic and mediastinal disorders
pleural Effusion
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2499
|
0.00%
0/2510
|
0.08%
2/2499 • Number of events 2
|
0.04%
1/2502 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.04%
1/2499 • Number of events 1
|
0.08%
2/2510 • Number of events 2
|
0.16%
4/2499 • Number of events 4
|
0.08%
2/2502 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.08%
2/2499 • Number of events 2
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Vascular disorders
Hematoma
|
0.00%
0/2499
|
0.00%
0/2510
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2502
|
|
Vascular disorders
Hypotension
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Vascular disorders
Lymphocele
|
0.00%
0/2499
|
0.00%
0/2510
|
0.00%
0/2499
|
0.04%
1/2502 • Number of events 1
|
|
Vascular disorders
lymphorrhoea
|
0.00%
0/2499
|
0.04%
1/2510 • Number of events 1
|
0.00%
0/2499
|
0.00%
0/2502
|
|
Vascular disorders
Orthostatic Hypotension
|
0.04%
1/2499 • Number of events 1
|
0.00%
0/2510
|
0.00%
0/2499
|
0.00%
0/2502
|
Other adverse events
Adverse event data not reported
Additional Information
P.J. Devereaux, MD, PhD, FRCPC
Population Health Research Institute
Phone: 905-527-4322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place