Trial Outcomes & Findings for Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery (NCT NCT02014402)
NCT ID: NCT02014402
Last Updated: 2017-06-14
Results Overview
Subjects achieving hemostasis at the target bleeding site by 5 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
181 participants
Primary outcome timeframe
From start of treatment until 5 minutes after treatment start
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
IG1202-A (Vascular)
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-B (Hepatic)
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-C (Soft Tissue)
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-D (Spinal)
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
35
|
85
|
|
Overall Study
Human Thrombin
|
20
|
20
|
23
|
57
|
|
Overall Study
Bovine Thrombin
|
11
|
10
|
12
|
28
|
|
Overall Study
COMPLETED
|
29
|
27
|
32
|
82
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
IG1202-A (Vascular)
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-B (Hepatic)
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-C (Soft Tissue)
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-D (Spinal)
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
1
|
|
Overall Study
Subject did not have transportation
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
Baseline characteristics by cohort
| Measure |
IG1202-A (Vascular)
n=31 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-B (Hepatic)
n=30 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-C (Soft Tissue)
n=35 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-D (Spinal)
n=85 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Human Thrombin
|
66.30 years
STANDARD_DEVIATION 12.427 • n=20 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
57.50 years
STANDARD_DEVIATION 13.987 • n=20 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
47.52 years
STANDARD_DEVIATION 13.885 • n=23 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
54.32 years
STANDARD_DEVIATION 16.733 • n=57 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
55.54 years
STANDARD_DEVIATION 16.017 • n=120 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Age, Continuous
Bovine Thrombin
|
71.82 years
STANDARD_DEVIATION 9.857 • n=11 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
56.50 years
STANDARD_DEVIATION 14.455 • n=10 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
47.67 years
STANDARD_DEVIATION 12.434 • n=12 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
54.04 years
STANDARD_DEVIATION 17.240 • n=28 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
56.39 years
STANDARD_DEVIATION 16.464 • n=61 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Age, Customized
12-17 · Human Thrombin
|
0 Participants
Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=2 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=2 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Age, Customized
12-17 · Bovine Thrombin
|
0 Participants
Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=2 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=2 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Age, Customized
18-64 · Human Thrombin
|
9 Participants
n=12 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
13 Participants
n=21 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
20 Participants
n=31 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
40 Participants
n=59 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
82 Participants
n=123 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Age, Customized
18-64 · Bovine Thrombin
|
3 Participants
n=12 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
8 Participants
n=21 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
11 Participants
n=31 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
19 Participants
n=59 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
41 Participants
n=123 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Age, Customized
>=65 · Human Thrombin
|
11 Participants
n=19 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
7 Participants
n=9 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
3 Participants
n=4 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
16 Participants
n=24 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
37 Participants
n=56 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Age, Customized
>=65 · Bovine Thrombin
|
8 Participants
n=19 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
2 Participants
n=9 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=4 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
8 Participants
n=24 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
19 Participants
n=56 Participants • Age categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Sex: Female, Male
Human Thrombin · Female
|
8 Participants
n=20 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
10 Participants
n=20 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
23 Participants
n=23 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
29 Participants
n=57 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
70 Participants
n=120 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Sex: Female, Male
Human Thrombin · Male
|
12 Participants
n=20 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
10 Participants
n=20 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
n=23 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
28 Participants
n=57 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
50 Participants
n=120 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Sex: Female, Male
Bovine Thrombin · Female
|
4 Participants
n=11 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
9 Participants
n=10 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
11 Participants
n=12 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
18 Participants
n=28 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
42 Participants
n=61 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Sex: Female, Male
Bovine Thrombin · Male
|
7 Participants
n=11 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=10 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=12 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
10 Participants
n=28 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
19 Participants
n=61 Participants • Gender categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
White (Caucasian) · Human Thrombin
|
14 Participants
n=23 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
13 Participants
n=19 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
15 Participants
n=23 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
55 Participants
n=82 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
97 Participants
n=147 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
White (Caucasian) · Bovine Thrombin
|
9 Participants
n=23 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
6 Participants
n=19 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
8 Participants
n=23 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
27 Participants
n=82 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
50 Participants
n=147 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
Black or African American · Human Thrombin
|
6 Participants
n=8 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
5 Participants
n=6 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
6 Participants
n=10 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
2 Participants
n=2 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
19 Participants
n=26 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
Black or African American · Bovine Thrombin
|
2 Participants
n=8 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=6 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
4 Participants
n=10 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
n=2 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
7 Participants
n=26 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
Asian · Human Thrombin
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
n=2 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
2 Participants
n=2 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
2 Participants
n=4 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
Asian · Bovine Thrombin
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
2 Participants
n=2 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
n=2 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
2 Participants
n=4 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native · Human Thrombin
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=2 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native · Bovine Thrombin
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=2 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander · Human Thrombin
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander · Bovine Thrombin
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
Other · Human Thrombin
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
|
Race/Ethnicity, Customized
Other · Bovine Thrombin
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
0 Participants
Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
1 Participants
n=1 Participants • Race categories are provided by number of subjects in the Human Thrombin and Bovine Thrombin treatment groups
|
PRIMARY outcome
Timeframe: From start of treatment until 5 minutes after treatment startPopulation: Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the modified intent-to-treat (mITT) population
Subjects achieving hemostasis at the target bleeding site by 5 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure
Outcome measures
| Measure |
IG1202-A (Vascular)
n=31 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-B (Hepatic)
n=30 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-C (Soft Tissue)
n=35 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-D (Spinal)
n=85 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)
n=181 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
|---|---|---|---|---|---|
|
Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS
Bovine Thrombin
|
54.5 percent of subjects achieving hemostasis
|
80.0 percent of subjects achieving hemostasis
|
91.7 percent of subjects achieving hemostasis
|
85.7 percent of subjects achieving hemostasis
|
80.3 percent of subjects achieving hemostasis
|
|
Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS
Human Thrombin
|
75.0 percent of subjects achieving hemostasis
|
75.0 percent of subjects achieving hemostasis
|
73.9 percent of subjects achieving hemostasis
|
82.5 percent of subjects achieving hemostasis
|
78.3 percent of subjects achieving hemostasis
|
SECONDARY outcome
Timeframe: From start of treatment until 4 minutes after treatment startPopulation: Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the mITT population
Cumulative proportion of subjects having achieved hemostasis by each of the following time points: * At 3 minutes following start of study treatment * At 4 minutes following start of study treatment
Outcome measures
| Measure |
IG1202-A (Vascular)
n=31 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-B (Hepatic)
n=30 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-C (Soft Tissue)
n=35 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-D (Spinal)
n=85 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)
n=181 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
|---|---|---|---|---|---|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 4 minutes: Human Thrombin
|
50.0 percent of subjects achieving hemostasis
|
65.0 percent of subjects achieving hemostasis
|
73.9 percent of subjects achieving hemostasis
|
78.9 percent of subjects achieving hemostasis
|
70.8 percent of subjects achieving hemostasis
|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 4 minutes: Bovine Thrombin
|
45.5 percent of subjects achieving hemostasis
|
70.0 percent of subjects achieving hemostasis
|
91.7 percent of subjects achieving hemostasis
|
78.6 percent of subjects achieving hemostasis
|
73.8 percent of subjects achieving hemostasis
|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 3 minutes: Human Thrombin
|
40.0 percent of subjects achieving hemostasis
|
45.0 percent of subjects achieving hemostasis
|
73.9 percent of subjects achieving hemostasis
|
70.2 percent of subjects achieving hemostasis
|
61.7 percent of subjects achieving hemostasis
|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 3 minutes: Bovine Thrombin
|
36.4 percent of subjects achieving hemostasis
|
60.0 percent of subjects achieving hemostasis
|
75.0 percent of subjects achieving hemostasis
|
71.4 percent of subjects achieving hemostasis
|
63.9 percent of subjects achieving hemostasis
|
SECONDARY outcome
Timeframe: From start of treatment up to surgical closure by layers of the exposed surgical field containing the TBS, a median of 34 minutesPopulation: Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the mITT population
Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments or maneuvers at the target bleeding site after the start of treatment
Outcome measures
| Measure |
IG1202-A (Vascular)
n=31 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-B (Hepatic)
n=30 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-C (Soft Tissue)
n=35 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-D (Spinal)
n=85 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)
n=181 Participants
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
|---|---|---|---|---|---|
|
Prevalence of Treatment Failures
Human Thrombin
|
25.0 percent of subjects
|
25.0 percent of subjects
|
26.1 percent of subjects
|
17.5 percent of subjects
|
21.7 percent of subjects
|
|
Prevalence of Treatment Failures
Bovine Thrombin
|
45.5 percent of subjects
|
20.0 percent of subjects
|
8.3 percent of subjects
|
14.3 percent of subjects
|
19.7 percent of subjects
|
Adverse Events
IG1202-A (Vascular): Human Thrombin
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
IG1202-A (Vascular): Bovine Thrombin
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
IG1202-B (Hepatic): Human Thrombin
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
IG1202-B (Hepatic): Bovine Thrombin
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
IG1202-C (Soft Tissue): Human Thrombin
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
IG1202-C (Soft Tissue): Bovine Thrombin
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
IG1202-D (Spinal): Human Thrombin
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
IG1202-D (Spinal): Bovine Thrombin
Serious events: 3 serious events
Other events: 24 other events
Deaths: 1 deaths
Overall (IG1202-A, -B, -C, and -D): Human Thrombin
Serious events: 10 serious events
Other events: 104 other events
Deaths: 0 deaths
Overall (IG1202-A, -B, -C, and -D): Bovine Thrombin
Serious events: 6 serious events
Other events: 52 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
IG1202-A (Vascular): Human Thrombin
n=20 participants at risk
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-A (Vascular): Bovine Thrombin
n=11 participants at risk
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-B (Hepatic): Human Thrombin
n=20 participants at risk
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-B (Hepatic): Bovine Thrombin
n=10 participants at risk
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-C (Soft Tissue): Human Thrombin
n=23 participants at risk
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-C (Soft Tissue): Bovine Thrombin
n=12 participants at risk
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-D (Spinal): Human Thrombin
n=57 participants at risk
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-D (Spinal): Bovine Thrombin
n=28 participants at risk
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
Overall (IG1202-A, -B, -C, and -D): Human Thrombin
n=120 participants at risk
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
Overall (IG1202-A, -B, -C, and -D): Bovine Thrombin
n=61 participants at risk
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Wound infection
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Dural tear
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
Other adverse events
| Measure |
IG1202-A (Vascular): Human Thrombin
n=20 participants at risk
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-A (Vascular): Bovine Thrombin
n=11 participants at risk
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-B (Hepatic): Human Thrombin
n=20 participants at risk
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-B (Hepatic): Bovine Thrombin
n=10 participants at risk
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-C (Soft Tissue): Human Thrombin
n=23 participants at risk
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-C (Soft Tissue): Bovine Thrombin
n=12 participants at risk
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-D (Spinal): Human Thrombin
n=57 participants at risk
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
IG1202-D (Spinal): Bovine Thrombin
n=28 participants at risk
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
Overall (IG1202-A, -B, -C, and -D): Human Thrombin
n=120 participants at risk
Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
Overall (IG1202-A, -B, -C, and -D): Bovine Thrombin
n=61 participants at risk
Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
15.8%
9/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.7%
3/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.2%
11/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
6.6%
4/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
18.2%
2/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.5%
2/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
4/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.9%
3/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
20.0%
2/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.5%
2/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.9%
3/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
40.0%
4/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.7%
2/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
12.3%
7/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.7%
3/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
12/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
13.1%
8/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Large intestine polyp
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Melaena
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
40.0%
8/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
60.0%
6/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
43.5%
10/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
33.3%
4/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
22.8%
13/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
21.4%
6/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
27.5%
33/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
26.2%
16/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Oesophagitis
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
60.0%
6/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.7%
2/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
16.7%
2/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.5%
2/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
7.1%
2/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
6/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
16.4%
10/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
General disorders
Asthenia
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
General disorders
Local swelling
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
20.0%
2/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
4/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.9%
3/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Gangrene
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Incision site infection
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
7.1%
2/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
2/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Postoperative wound infection
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
4/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
2/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Incision site complication
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
2/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
5/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
27.3%
3/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
35.0%
7/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
50.0%
5/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
95.7%
22/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
91.7%
11/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
57.9%
33/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
67.9%
19/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
55.8%
67/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
62.3%
38/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Seroma
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
18.2%
2/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.5%
2/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.7%
2/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.9%
3/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intra-abdominal haemangioma
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
2/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
20.0%
4/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
30.0%
3/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.5%
6/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
7.1%
2/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
12/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
6.6%
4/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Vascular disorders
Haematoma
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.1%
1/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.3%
3/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.7%
3/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
4/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.9%
3/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.7%
2/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
2/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
15.0%
3/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
20.0%
2/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
4/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.9%
3/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
16.7%
2/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.9%
3/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.7%
2/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.7%
2/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
General disorders
Fatigue
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
25.0%
5/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
16.7%
2/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
7.1%
2/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
6/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.2%
5/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
General disorders
Visceral pain
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
7.0%
4/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
4/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
2/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.7%
2/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
15.0%
3/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
4/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Investigations
Urine output decreased
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Investigations
Weight decreased
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
2/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.3%
3/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
4/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
17.5%
10/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
17.9%
5/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.2%
11/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
9.8%
6/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.5%
2/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Psychiatric disorders
Delirium
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.7%
2/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
2/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
7.1%
2/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.9%
3/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.7%
2/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.7%
2/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
1/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.0%
1/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.83%
1/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
10.0%
2/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.7%
2/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.8%
1/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.5%
2/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.7%
2/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Nervous system disorders
Lethargy
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
8.3%
1/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
16.7%
2/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.9%
3/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
General disorders
Chills
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.3%
3/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.6%
1/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
1.6%
1/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.3%
3/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
2.5%
3/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/11 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/20 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/10 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
4.3%
1/23 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/12 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
5.3%
3/57 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/28 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
3.3%
4/120 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
0.00%
0/61 • Adverse event data (safety population) were collected from the time informed consent was obtained through the Post-Operative Day 30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the study, after providing Sponsor 30 days' notice prior to submitting a manuscript or other materials related to the study to any outside party. At Sponsor's request, site will remove any confidential information (other than study results) and site will, upon Sponsor's request, delay publication or presentation for a period of up to 120 days to allow Sponsor to protect its interests in any Sponsor interventions.
- Publication restrictions are in place
Restriction type: OTHER