Trial Outcomes & Findings for A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion (NCT NCT01222117)
NCT ID: NCT01222117
Last Updated: 2017-01-16
Results Overview
The proportion of subjects with \>50% thrombolysis at the end of treatment compared to baseline by arteriography.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
174 participants
Primary outcome timeframe
5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)
Results posted on
2017-01-16
Participant Flow
Participant milestones
| Measure |
Plasmin Open-label Treatment Group A
Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group B
Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group C
Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group D
Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasminogen Activator Blinded Group E
PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment.
|
PA Placebo Blinded Treatment Arm F
PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator.
|
Plasmin Open-label Treatment Group G
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group H
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group I
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group J
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group M
Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
22
|
20
|
9
|
10
|
13
|
12
|
23
|
19
|
6
|
|
Overall Study
COMPLETED
|
17
|
19
|
22
|
19
|
8
|
9
|
13
|
12
|
20
|
17
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
1
|
1
|
1
|
0
|
0
|
3
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion
Baseline characteristics by cohort
| Measure |
Plasmin Open-label Treatment Group A
n=20 Participants
Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group B
n=20 Participants
Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group C
n=22 Participants
Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group D
n=20 Participants
Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasminogen Activator Blinded Group E
n=9 Participants
PA administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment.
|
PA Placebo Blinded Treatment Arm F
n=10 Participants
PA placebo (normal saline for injection) administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator.
|
Plasmin Open-label Treatment Group G
n=13 Participants
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group H
n=12 Participants
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group I
n=23 Participants
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group J
n=19 Participants
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group M
n=6 Participants
Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
5 participants
n=21 Participants
|
5 participants
n=8 Participants
|
8 participants
n=8 Participants
|
7 participants
n=24 Participants
|
13 participants
n=42 Participants
|
12 participants
n=42 Participants
|
3 participants
n=42 Participants
|
95 participants
n=42 Participants
|
|
Age, Customized
>=65 years
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
10 participants
n=4 Participants
|
4 participants
n=21 Participants
|
5 participants
n=8 Participants
|
5 participants
n=8 Participants
|
5 participants
n=24 Participants
|
10 participants
n=42 Participants
|
7 participants
n=42 Participants
|
3 participants
n=42 Participants
|
79 participants
n=42 Participants
|
|
Gender
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
|
Gender
Male
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
135 Participants
n=42 Participants
|
|
Region of Enrollment
Czech Republic
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
5 participants
n=8 Participants
|
5 participants
n=24 Participants
|
9 participants
n=42 Participants
|
7 participants
n=42 Participants
|
1 participants
n=42 Participants
|
45 participants
n=42 Participants
|
|
Region of Enrollment
Romania
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
3 participants
n=42 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
15 participants
n=42 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
5 participants
n=42 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
5 participants
n=42 Participants
|
|
Region of Enrollment
Slovakia
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
2 participants
n=24 Participants
|
11 participants
n=42 Participants
|
9 participants
n=42 Participants
|
5 participants
n=42 Participants
|
40 participants
n=42 Participants
|
|
Region of Enrollment
Serbia
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
6 participants
n=8 Participants
|
4 participants
n=8 Participants
|
5 participants
n=24 Participants
|
1 participants
n=42 Participants
|
3 participants
n=42 Participants
|
0 participants
n=42 Participants
|
43 participants
n=42 Participants
|
|
Region of Enrollment
Bulgaria
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
5 participants
n=42 Participants
|
|
Region of Enrollment
Peru
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
4 participants
n=42 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
3 participants
n=42 Participants
|
|
Region of Enrollment
India
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
4 participants
n=42 Participants
|
|
Region of Enrollment
Ukraine
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)Population: In groups A-D, G and H, 8 subjects were excluded (EOT arteriogram missing or not read, did not receive \>=90% of dose). In groups I and J, 11 subjects were excluded (BOC not inserted/appropriately inflated, missing an arteriogram). In group F, 1 subject was not dosed and 4 subjects were excluded (did not receive \>=90% of dose).
The proportion of subjects with \>50% thrombolysis at the end of treatment compared to baseline by arteriography.
Outcome measures
| Measure |
Plasmin Open-label Treatment Group A
n=16 Participants
Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group B
n=19 Participants
Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group C
n=21 Participants
Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group D
n=19 Participants
Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasminogen Activator Blinded Group E
n=9 Participants
PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment.
|
PA Placebo Blinded Treatment Arm F
n=5 Participants
PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator.
|
Plasmin Open-label Treatment Group G
n=12 Participants
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group H
n=12 Participants
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group I
n=15 Participants
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group J
n=14 Participants
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group M
n=6 Participants
Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Proportion of Subjects With >50% Thrombolysis
|
43.8 percentage of participants
|
47.4 percentage of participants
|
81.0 percentage of participants
|
47.4 percentage of participants
|
88.9 percentage of participants
|
40.0 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
73.3 percentage of participants
|
42.9 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability.
Outcome measures
| Measure |
Plasmin Open-label Treatment Group A
n=20 Participants
Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group B
n=20 Participants
Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group C
n=22 Participants
Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group D
n=20 Participants
Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasminogen Activator Blinded Group E
n=9 Participants
PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment.
|
PA Placebo Blinded Treatment Arm F
n=9 Participants
PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator.
|
Plasmin Open-label Treatment Group G
n=13 Participants
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group H
n=12 Participants
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group I
n=21 Participants
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group J
n=17 Participants
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group M
n=6 Participants
Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.
Adverse events
|
80.0 percentage of participants
|
60.0 percentage of participants
|
81.8 percentage of participants
|
70.0 percentage of participants
|
77.8 percentage of participants
|
88.9 percentage of participants
|
69.2 percentage of participants
|
58.3 percentage of participants
|
66.7 percentage of participants
|
58.8 percentage of participants
|
50.0 percentage of participants
|
|
The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.
Serious adverse events
|
50.0 percentage of participants
|
20.0 percentage of participants
|
27.3 percentage of participants
|
20.0 percentage of participants
|
22.2 percentage of participants
|
55.6 percentage of participants
|
30.8 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
11.8 percentage of participants
|
0 percentage of participants
|
|
The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.
Major bleeding events
|
15.0 percentage of participants
|
5.0 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.
Minor bleeding events
|
5.0 percentage of participants
|
20.0 percentage of participants
|
9.1 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
46.2 percentage of participants
|
8.3 percentage of participants
|
28.6 percentage of participants
|
11.8 percentage of participants
|
33.3 percentage of participants
|
|
The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.
Deaths
|
5.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.
Abnormal laboratory values
|
15.0 percentage of participants
|
10.0 percentage of participants
|
13.7 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
22.2 percentage of participants
|
15.4 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Plasmin Open-label Treatment Group A
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Plasmin Open-label Treatment Group B
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Plasmin Open-label Treatment Group C
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Plasmin Open-label Treatment Group D
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Plasminogen Activator Blinded Group E
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
PA Placebo Blinded Treatment Arm F
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Plasmin Open-label Treatment Group G
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Plasmin Open-label Treatment Group H
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Plasmin Open-label Treatment Group I
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Plasmin Open-label Treatment Group J
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Plasmin Open-label Treatment Group M
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Plasmin Open-label Treatment Group A
n=20 participants at risk
Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group B
n=20 participants at risk
Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group C
n=22 participants at risk
Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group D
n=20 participants at risk
Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasminogen Activator Blinded Group E
n=9 participants at risk
PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment.
|
PA Placebo Blinded Treatment Arm F
n=9 participants at risk
PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator.
|
Plasmin Open-label Treatment Group G
n=13 participants at risk
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group H
n=12 participants at risk
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group I
n=21 participants at risk
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group J
n=17 participants at risk
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group M
n=6 participants at risk
Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Nervous system disorders
Syncope
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Infections and infestations
Sepsis
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Peripheral ischaemia
|
20.0%
4/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
33.3%
3/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
16.7%
2/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Peripheral embolism
|
20.0%
4/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Thrombosis
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
8.3%
1/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Reocclusion
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Ischaemia
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
14.3%
3/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Renal and urinary disorders
Renal failure acute
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Haematoma
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Shock haemorrhagic
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Procedural complication
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
8.3%
1/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Nervous system disorders
Peroneal nerve palsy
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Multi-organ failure
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Catheter site haemorrhage
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
9.5%
2/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Ischaemic limb pain
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Reperfusion injury
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Catheter site pain
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
Other adverse events
| Measure |
Plasmin Open-label Treatment Group A
n=20 participants at risk
Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group B
n=20 participants at risk
Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group C
n=22 participants at risk
Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group D
n=20 participants at risk
Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasminogen Activator Blinded Group E
n=9 participants at risk
PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment.
|
PA Placebo Blinded Treatment Arm F
n=9 participants at risk
PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
Placebo: Normal saline for injection at the same volume as the plasminogen activator.
|
Plasmin Open-label Treatment Group G
n=13 participants at risk
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group H
n=12 participants at risk
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group I
n=21 participants at risk
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group J
n=17 participants at risk
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
Plasmin Open-label Treatment Group M
n=6 participants at risk
Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Plasmin: Plasmin prepared in 0.9% saline for injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Peripheral embolism
|
20.0%
4/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
27.3%
6/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
15.4%
2/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
19.0%
4/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
17.6%
3/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Haematoma
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
33.3%
3/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
30.8%
4/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
8.3%
1/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
16.7%
1/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
9.5%
2/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
33.3%
2/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Hypertension
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
9.1%
2/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
15.0%
3/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.8%
2/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Ischaemia
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
16.7%
1/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.8%
2/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Hypotension
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Ischaemic limb pain
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Peripheral artery dissection
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Infusion related reaction
|
25.0%
5/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
22.7%
5/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
30.0%
6/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
22.2%
2/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
44.4%
4/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.8%
2/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Pyrexia
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
13.6%
3/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
22.2%
2/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
8.3%
1/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
16.7%
1/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Oedema peripheral
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Chest discomfort
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Local swelling
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Puncture site pain
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Reocclusion
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
19.0%
4/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
9.5%
2/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
33.3%
2/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
9.1%
2/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Renal and urinary disorders
Renal failure acute
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Haemoglobin decreased
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
15.4%
2/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Blood glucose increased
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Haematocrit decreased
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
8.3%
1/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
8.3%
1/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
10.0%
2/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
16.7%
1/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.9%
1/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
16.7%
1/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Infections and infestations
Graft infection
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
8.3%
1/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
8.3%
1/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
8.3%
1/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Device leakage
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
7.7%
1/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Complication of device removal
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Injection site haematoma
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Injection site haemorrhage
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
General disorders
Pain
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Renal and urinary disorders
Renal failure
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Blood pressure increased
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Hepatic enzyme increased
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Blood fibrinogen decreased
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Blood and lymphatic system disorders
Neutrophilia
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.8%
1/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
4.5%
1/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Infections and infestations
Oral candidiasis
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Immune system disorders
Hypersensitivity
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Infections and infestations
Postoperatvie wound infection
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
11.1%
1/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
5.0%
1/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/22
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/20
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/9
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/13
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/12
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/21
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/17
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
0.00%
0/6
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
|
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 60 days to allow sponsor to protect its interests in any sponsor inventions
- Publication restrictions are in place
Restriction type: OTHER