Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 613 for:    PLG

A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01222117
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : May 30, 2016
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Peripheral Arterial Occlusion
Interventions Biological: Plasmin
Biological: Plasminogen Activator
Other: Placebo
Enrollment 174
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Plasmin Open-label Treatment Group A Plasmin Open-label Treatment Group B Plasmin Open-label Treatment Group C Plasmin Open-label Treatment Group D Plasminogen Activator Blinded Group E PA Placebo Blinded Treatment Arm F Plasmin Open-label Treatment Group G Plasmin Open-label Treatment Group H Plasmin Open-label Treatment Group I Plasmin Open-label Treatment Group J Plasmin Open-label Treatment Group M
Hide Arm/Group Description

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

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

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

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

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 (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.

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

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

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

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

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

Period Title: Overall Study
Started 20 20 22 20 9 10 13 12 23 19 6
Completed 17 19 22 19 8 9 13 12 20 17 6
Not Completed 3 1 0 1 1 1 0 0 3 2 0
Arm/Group Title Plasmin Open-label Treatment Group A Plasmin Open-label Treatment Group B Plasmin Open-label Treatment Group C Plasmin Open-label Treatment Group D Plasminogen Activator Blinded Group E PA Placebo Blinded Treatment Arm F Plasmin Open-label Treatment Group G Plasmin Open-label Treatment Group H Plasmin Open-label Treatment Group I Plasmin Open-label Treatment Group J Plasmin Open-label Treatment Group M Total
Hide Arm/Group Description

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

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

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

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

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 (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.

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

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 20 20 22 20 9 10 13 12 23 19 6 174
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 22 participants 20 participants 9 participants 10 participants 13 participants 12 participants 23 participants 19 participants 6 participants 174 participants
<65 years 12 10 10 10 5 5 8 7 13 12 3 95
>=65 years 8 10 12 10 4 5 5 5 10 7 3 79
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 22 participants 20 participants 9 participants 10 participants 13 participants 12 participants 23 participants 19 participants 6 participants 174 participants
Female
3
  15.0%
3
  15.0%
5
  22.7%
7
  35.0%
0
   0.0%
3
  30.0%
2
  15.4%
3
  25.0%
7
  30.4%
5
  26.3%
1
  16.7%
39
  22.4%
Male
17
  85.0%
17
  85.0%
17
  77.3%
13
  65.0%
9
 100.0%
7
  70.0%
11
  84.6%
9
  75.0%
16
  69.6%
14
  73.7%
5
  83.3%
135
  77.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 22 participants 20 participants 9 participants 10 participants 13 participants 12 participants 23 participants 19 participants 6 participants 174 participants
Czech Republic 4 4 3 5 1 1 5 5 9 7 1 45
Romania 0 0 3 0 0 0 0 0 0 0 0 3
Belgium 3 1 3 2 2 2 1 0 1 0 0 15
United States 1 1 1 1 1 0 0 0 0 0 0 5
Poland 0 1 1 2 0 0 1 0 0 0 0 5
Slovakia 3 2 4 1 1 0 2 2 11 9 5 40
Serbia 6 7 3 4 4 6 4 5 1 3 0 43
Bulgaria 1 1 2 0 0 0 0 0 1 0 0 5
Peru 1 0 0 3 0 0 0 0 0 0 0 4
Germany 0 0 1 2 0 0 0 0 0 0 0 3
India 1 2 1 0 0 0 0 0 0 0 0 4
Ukraine 0 1 0 0 0 1 0 0 0 0 0 2
1.Primary Outcome
Title The Proportion of Subjects With >50% Thrombolysis
Hide Description The proportion of subjects with >50% thrombolysis at the end of treatment compared to baseline by arteriography.
Time Frame 5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Plasmin Open-label Treatment Group A Plasmin Open-label Treatment Group B Plasmin Open-label Treatment Group C Plasmin Open-label Treatment Group D Plasminogen Activator Blinded Group E PA Placebo Blinded Treatment Arm F Plasmin Open-label Treatment Group G Plasmin Open-label Treatment Group H Plasmin Open-label Treatment Group I Plasmin Open-label Treatment Group J Plasmin Open-label Treatment Group M
Hide Arm/Group Description:

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

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

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

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

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 (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.

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

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

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

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

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 Number of Participants Analyzed 16 19 21 19 9 5 12 12 15 14 6
Measure Type: Number
Unit of Measure: percentage of participants
43.8 47.4 81.0 47.4 88.9 40.0 66.7 66.7 73.3 42.9 33.3
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
Arm/Group Title Plasmin Open-label Treatment Group A Plasmin Open-label Treatment Group B Plasmin Open-label Treatment Group C Plasmin Open-label Treatment Group D Plasminogen Activator Blinded Group E PA Placebo Blinded Treatment Arm F Plasmin Open-label Treatment Group G Plasmin Open-label Treatment Group H Plasmin Open-label Treatment Group I Plasmin Open-label Treatment Group J Plasmin Open-label Treatment Group M
Hide Arm/Group Description:

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

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

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

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

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 (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.

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

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

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

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

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 Number of Participants Analyzed 20 20 22 20 9 9 13 12 21 17 6
Measure Type: Number
Unit of Measure: percentage of participants
Adverse events 80.0 60.0 81.8 70.0 77.8 88.9 69.2 58.3 66.7 58.8 50.0
Serious adverse events 50.0 20.0 27.3 20.0 22.2 55.6 30.8 25.0 33.3 11.8 0
Major bleeding events 15.0 5.0 4.5 0 11.1 11.1 0 0 9.5 0 0
Minor bleeding events 5.0 20.0 9.1 20.0 33.3 33.3 46.2 8.3 28.6 11.8 33.3
Deaths 5.0 0 0 0 11.1 11.1 0 0 0 0 0
Abnormal laboratory values 15.0 10.0 13.7 0 11.1 22.2 15.4 0 4.8 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)
 
Arm/Group Title Plasmin Open-label Treatment Group A Plasmin Open-label Treatment Group B Plasmin Open-label Treatment Group C Plasmin Open-label Treatment Group D Plasminogen Activator Blinded Group E PA Placebo Blinded Treatment Arm F Plasmin Open-label Treatment Group G Plasmin Open-label Treatment Group H Plasmin Open-label Treatment Group I Plasmin Open-label Treatment Group J Plasmin Open-label Treatment Group M
Hide Arm/Group Description

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

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

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

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

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 (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.

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

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

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

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

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

All-Cause Mortality
Plasmin Open-label Treatment Group A Plasmin Open-label Treatment Group B Plasmin Open-label Treatment Group C Plasmin Open-label Treatment Group D Plasminogen Activator Blinded Group E PA Placebo Blinded Treatment Arm F Plasmin Open-label Treatment Group G Plasmin Open-label Treatment Group H Plasmin Open-label Treatment Group I Plasmin Open-label Treatment Group J Plasmin Open-label Treatment Group M
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Plasmin Open-label Treatment Group A Plasmin Open-label Treatment Group B Plasmin Open-label Treatment Group C Plasmin Open-label Treatment Group D Plasminogen Activator Blinded Group E PA Placebo Blinded Treatment Arm F Plasmin Open-label Treatment Group G Plasmin Open-label Treatment Group H Plasmin Open-label Treatment Group I Plasmin Open-label Treatment Group J Plasmin Open-label Treatment Group M
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/20 (50.00%)   4/20 (20.00%)   6/22 (27.27%)   4/20 (20.00%)   2/9 (22.22%)   5/9 (55.56%)   4/13 (30.77%)   3/12 (25.00%)   7/21 (33.33%)   2/17 (11.76%)   0/6 (0.00%) 
Cardiac disorders                       
Myocardial infarction  0/20 (0.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders                       
Colitis ischaemic  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
General disorders                       
Vessel puncture site reaction  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Multi-organ failure  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Catheter site haemorrhage  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Puncture site haemorrhage  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  1/17 (5.88%)  0/6 (0.00%) 
Catheter site pain  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/17 (0.00%)  0/6 (0.00%) 
Infections and infestations                       
Sepsis  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications                       
Reocclusion  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  1/21 (4.76%)  1/17 (5.88%)  0/6 (0.00%) 
Vascular graft thrombosis  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Anaemia postoperative  0/20 (0.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Anastomotic haemorrhage  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Graft thrombosis  0/20 (0.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  1/17 (5.88%)  0/6 (0.00%) 
Procedural complication  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Post procedural haematoma  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Operative haemorrhage  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/17 (0.00%)  0/6 (0.00%) 
Nervous system disorders                       
Peroneal nerve palsy  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Cerebral haemorrhage  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Syncope  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders                       
Renal failure acute  1/20 (5.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Haematuria  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
Acute respiratory distress syndrome  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Respiratory failure  0/20 (0.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Vascular disorders                       
Peripheral ischaemia  4/20 (20.00%)  0/20 (0.00%)  1/22 (4.55%)  2/20 (10.00%)  0/9 (0.00%)  3/9 (33.33%)  0/13 (0.00%)  2/12 (16.67%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Peripheral embolism  4/20 (20.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Thrombosis  1/20 (5.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Ischaemia  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  3/21 (14.29%)  0/17 (0.00%)  0/6 (0.00%) 
Femoral arterial stenosis  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Haematoma  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/17 (0.00%)  0/6 (0.00%) 
Shock haemorrhagic  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Arterial haemorrhage  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Arterial thrombosis limb  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  0/17 (0.00%)  0/6 (0.00%) 
Ischaemic limb pain  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/17 (0.00%)  0/6 (0.00%) 
Reperfusion injury  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/17 (0.00%)  0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Plasmin Open-label Treatment Group A Plasmin Open-label Treatment Group B Plasmin Open-label Treatment Group C Plasmin Open-label Treatment Group D Plasminogen Activator Blinded Group E PA Placebo Blinded Treatment Arm F Plasmin Open-label Treatment Group G Plasmin Open-label Treatment Group H Plasmin Open-label Treatment Group I Plasmin Open-label Treatment Group J Plasmin Open-label Treatment Group M
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/20 (70.00%)   11/20 (55.00%)   18/22 (81.82%)   14/20 (70.00%)   7/9 (77.78%)   8/9 (88.89%)   7/13 (53.85%)   5/12 (41.67%)   12/21 (57.14%)   10/17 (58.82%)   3/6 (50.00%) 
Blood and lymphatic system disorders                       
Anaemia  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  1/9 (11.11%)  0/13 (0.00%)  1/12 (8.33%)  1/21 (4.76%)  0/17 (0.00%)  0/6 (0.00%) 
Hypercoagulation  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  2/20 (10.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Thrombocytopenia  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Lymphopenia  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Anaemia of chronic disease  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Leukocytosis  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Lymphocytosis  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Neutrophilia  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Cardiac disorders                       
Angina pectoris  0/20 (0.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Cardiac failure  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Tachycardia  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders                       
Nausea  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  1/12 (8.33%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Vomiting  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  2/20 (10.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  1/6 (16.67%) 
Constipation  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/17 (0.00%)  0/6 (0.00%) 
General disorders                       
Infusion related reaction  5/20 (25.00%)  2/20 (10.00%)  5/22 (22.73%)  6/20 (30.00%)  2/9 (22.22%)  4/9 (44.44%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  2/17 (11.76%)  0/6 (0.00%) 
Pyrexia  0/20 (0.00%)  1/20 (5.00%)  3/22 (13.64%)  2/20 (10.00%)  0/9 (0.00%)  2/9 (22.22%)  0/13 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Puncture site haemorrhage  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  1/17 (5.88%)  1/6 (16.67%) 
Oedema peripheral  1/20 (5.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Chest discomfort  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Infusion site haemorrhage  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Local swelling  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Puncture site pain  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/17 (5.88%)  0/6 (0.00%) 
Vessel puncture site haematoma  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Device leakage  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Complication of device removal  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Injection site haematoma  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Injection site haemorrhage  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Pain  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Immune system disorders                       
Hypersensitivity  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Infections and infestations                       
Graft infection  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Oral candidiasis  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Post procedural infection  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Postoperatvie wound infection  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications                       
Reocclusion  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  4/21 (19.05%)  0/17 (0.00%)  0/6 (0.00%) 
Vascular graft thrombosis  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Vascular graft complication  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Procedural pain  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Investigations                       
Haemoglobin decreased  1/20 (5.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  2/13 (15.38%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Aspartate aminotransferase increased  0/20 (0.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Blood glucose increased  0/20 (0.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Haematocrit decreased  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Alanine aminotransferase increased  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Blood cholesterol increased  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Red blood cell count decreased  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Blood pressure increased  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/17 (0.00%)  0/6 (0.00%) 
Hepatic enzyme increased  1/20 (5.00%)  0/20 (0.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Blood alkaline phosphatase increased  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Blood fibrinogen decreased  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Gamma-glutamyltransferase increased  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders                       
Hypercholesterolaemia  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/17 (5.88%)  0/6 (0.00%) 
Hyperglycaemia  1/20 (5.00%)  1/20 (5.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Hypokalaemia  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Acidosis  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Hypoalbuminaemia  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders                       
Pain in extremity  2/20 (10.00%)  2/20 (10.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  1/17 (5.88%)  2/6 (33.33%) 
Back pain  0/20 (0.00%)  0/20 (0.00%)  2/22 (9.09%)  1/20 (5.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/17 (5.88%)  0/6 (0.00%) 
Musculoskeletal pain  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Rhabdomyolysis  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Groin pain  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Muscle spasms  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
Lung neoplasm malignant  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Nervous system disorders                       
Presyncope  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Paraesthesia  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  1/6 (16.67%) 
Dizziness  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Psychiatric disorders                       
Disorientation  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Restlessness  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/17 (5.88%)  0/6 (0.00%) 
Anxiety  0/20 (0.00%)  0/20 (0.00%)  1/22 (4.55%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Insomnia  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Sleep disorder  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders                       
Haematuria  0/20 (0.00%)  1/20 (5.00%)  1/22 (4.55%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/17 (5.88%)  0/6 (0.00%) 
Renal failure acute  1/20 (5.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Oliguria  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Renal failure  1/20 (5.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Proteinuria  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Renal failure chronic  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
Cough  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Dyspnoea  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Wheezing  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders                       
Dermatitis allergic  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Erythema  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Skin discolouration  1/20 (5.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Vascular disorders                       
Peripheral embolism  4/20 (20.00%)  2/20 (10.00%)  6/22 (27.27%)  1/20 (5.00%)  1/9 (11.11%)  1/9 (11.11%)  2/13 (15.38%)  0/12 (0.00%)  4/21 (19.05%)  3/17 (17.65%)  0/6 (0.00%) 
Haematoma  0/20 (0.00%)  2/20 (10.00%)  1/22 (4.55%)  2/20 (10.00%)  3/9 (33.33%)  1/9 (11.11%)  4/13 (30.77%)  1/12 (8.33%)  0/21 (0.00%)  0/17 (0.00%)  1/6 (16.67%) 
Peripheral ischaemia  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Arterial thrombosis limb  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/20 (5.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  1/17 (5.88%)  2/6 (33.33%) 
Hypertension  1/20 (5.00%)  0/20 (0.00%)  2/22 (9.09%)  3/20 (15.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  2/17 (11.76%)  0/6 (0.00%) 
Ischaemia  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/17 (0.00%)  1/6 (16.67%) 
Femoral artery embolism  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  1/21 (4.76%)  2/17 (11.76%)  0/6 (0.00%) 
Hypotension  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  2/20 (10.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Ischaemic limb pain  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  1/17 (5.88%)  0/6 (0.00%) 
Extremity necrosis  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Iliac artery stenosis  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/17 (5.88%)  0/6 (0.00%) 
Labile blood pressure  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Peripheral artery dissection  0/20 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/17 (5.88%)  0/6 (0.00%) 
Peripheral artery aneurysm  0/20 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/20 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/17 (0.00%)  0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Name/Title: Kimberly Steinmann, MD
Organization: Grifols Therapeutics
Phone: 919-308-5444
Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01222117     History of Changes
Other Study ID Numbers: T05018-2004
2010-019760-36 ( EudraCT Number )
First Submitted: October 13, 2010
First Posted: October 18, 2010
Results First Submitted: March 9, 2016
Results First Posted: May 30, 2016
Last Update Posted: January 16, 2017