Trial Outcomes & Findings for Octaplas Pediatric Plasma Replacement Trial (NCT NCT02050841)
NCT ID: NCT02050841
Last Updated: 2020-06-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
up to 6 days
Results posted on
2020-06-23
Participant Flow
Participant milestones
| Measure |
Octaplas
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Octaplas Pediatric Plasma Replacement Trial
Baseline characteristics by cohort
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
|
Age, Categorical
<=18 years
|
50 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
2.0 years
STANDARD_DEVIATION 3.98 • n=99 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
ABO Blood Group
A
|
16 Participants
n=99 Participants
|
|
ABO Blood Group
B
|
9 Participants
n=99 Participants
|
|
ABO Blood Group
AB
|
4 Participants
n=99 Participants
|
|
ABO Blood Group
O
|
21 Participants
n=99 Participants
|
|
Height
|
78.1 centimeters
STANDARD_DEVIATION 30.49 • n=99 Participants
|
|
Weight
|
13.66 kilograms
STANDARD_DEVIATION 21.589 • n=99 Participants
|
|
BMI
|
16.88 kg/m^2
STANDARD_DEVIATION 5.421 • n=99 Participants
|
PRIMARY outcome
Timeframe: up to 6 daysOutcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Any SAE
|
5 participants
|
—
|
|
Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Any SAE related to Octaplas
|
0 participants
|
—
|
|
Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Any ADR
|
0 participants
|
—
|
|
Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Any ADR, SAE, HFE TEE, or TE leading to withdrawal
|
0 participants
|
—
|
|
Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Any ADR, SAE, HFE, TEE, or TE leading to death
|
1 participants
|
—
|
|
Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
Any study death related to Octaplas
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: up to 6 daysAssesses Pre- and Post-infusion for Infusion Episode 1
Outcome measures
| Measure |
Octaplas
n=13 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=37 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Monitoring of Clinically Significant Changes in White Blood Cells
|
5.3 10^3/µL
Interval -4.7 to 28.3
|
2.05 10^3/µL
Interval -12.3 to 9.3
|
PRIMARY outcome
Timeframe: up to 6 daysAssesses Pre- and Post-infusion for Infusion Episode 1
Outcome measures
| Measure |
Octaplas
n=13 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=37 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Monitoring of Clinically Significant Changes in Red Blood Cells
|
-0.34 10^6/µL
Interval -1.4 to 0.6
|
-0.06 10^6/µL
Interval -1.8 to 1.8
|
PRIMARY outcome
Timeframe: up to 6 daysAssesses Pre- and Post-infusion for Infusion Episode 1
Outcome measures
| Measure |
Octaplas
n=13 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=37 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Monitoring of Clinically Significant Changes in Hemoglobin
|
-0.70 g/dL
Interval -3.9 to 2.7
|
0.80 g/dL
Interval -4.6 to 5.2
|
PRIMARY outcome
Timeframe: up to 6 daysAssesses Pre- and Post-infusion for Infusion Episode 1
Outcome measures
| Measure |
Octaplas
n=13 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=37 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Monitoring of Clinically Significant Changes in Hematocrit
|
-2.35 volume percentage of RBC in blood
Interval -10.8 to 6.5
|
1.35 volume percentage of RBC in blood
Interval -14.6 to 16.2
|
PRIMARY outcome
Timeframe: up to 6 daysAssesses Pre- and Post-infusion for Infusion Episode 1
Outcome measures
| Measure |
Octaplas
n=13 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=37 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)
|
1.6 fL
Interval -5.4 to 6.3
|
1.85 fL
Interval -22.8 to 9.1
|
PRIMARY outcome
Timeframe: up to 6 daysAssesses Pre- and Post-infusion for Infusion Episode 1
Outcome measures
| Measure |
Octaplas
n=13 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=37 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)
|
0.85 pg
Interval -1.8 to 2.9
|
1.00 pg
Interval -8.3 to 5.6
|
PRIMARY outcome
Timeframe: up to 6 daysAssesses Pre- and Post-infusion for Infusion Episode 1
Outcome measures
| Measure |
Octaplas
n=13 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=37 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)
|
-0.15 g/dL
Interval -0.9 to 4.2
|
0.20 g/dL
Interval -1.2 to 2.8
|
PRIMARY outcome
Timeframe: up to 6 daysAssesses Pre- and Post-infusion for Infusion Episode 1
Outcome measures
| Measure |
Octaplas
n=13 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=37 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW)
|
0.10 % variation of RBC size
Interval -3.9 to 3.0
|
0.40 % variation of RBC size
Interval -2.1 to 4.2
|
PRIMARY outcome
Timeframe: up to 6 daysAssesses Pre- and Post-infusion for Infusion Episode 1
Outcome measures
| Measure |
Octaplas
n=13 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=37 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Monitoring of Clinically Significant Changes in Platelets
|
-105.5 10^3/µL
Interval -210.0 to 15.0
|
-167.00 10^3/µL
Interval -410.0 to 215.0
|
SECONDARY outcome
Timeframe: up to 6 daysThis hemostatic parameter is figured out in the lab and helps to diagnose a bleeding disorder or excessive clotting disorder. The change of INR before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.
Outcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
Shift from Not Clinically Significant to Normal
|
1 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
Remained Normal
|
8 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
Remained Not Clinically Significant
|
11 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
Shift from Normal to Not Clinically Significant
|
25 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
Shift to or from Clinically Significant
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: up to 6 daysThis hemostatic parameter is figured out in the lab and measures the time it takes for your blood to clot (the higher the PT the longer it takes your blood to clot). The change of PT before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.
Outcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
Shift from Not Clinically Significant to Normal
|
1 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
Remained Normal
|
8 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
Remained Not Clinically Significant
|
18 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
Shift from Normal to Not Clinically Significant
|
19 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
Shift to or from Clinically Significant
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: up to 6 daysTEG and ROTEM are methods of testing the efficiency of blood coagulation. The results were compared by looking at potential trends from TEG and ROTEM between pre-infusion vs post-infusion time points.
Outcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
Shift from Not Clinically Significant to Normal
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
Remained Normal
|
40 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
Remained Not Clinically Significant
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
Shift from Normal to Not Clinically Significant
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
Shift to or from Clinically Significant
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to 6 daysaPTT measures the length of time (in seconds) that it takes for clotting to occur in a test cube. The higher the number of seconds the longer it takes the blood to clot. The changes between pre - and post infusion were analyzed
Outcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
From (NCS) Not Clinically Significant to Normal
|
5 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
Remained Normal
|
18 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
Remained Not Clinically Significant (NCS)
|
12 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
Shift from Normal to Not Clinically Significant
|
9 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
NCS to Clinically Significant Shift
|
1 participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
Clinically Significant to NCS shift
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: up to 6 daysNormal infusion: Replacement of multiple clotting factors Bypass priming: Limit hemodilution and reduce transfusion requirements Bypass warming up: Rewarm patients suffering from hypothermia during the surgery process
Outcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
Normal Infusion
|
15 mL/kg
Standard Deviation 14.17
|
—
|
|
Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
Bypass Priming
|
20.2 mL/kg
Standard Deviation 7.82
|
—
|
|
Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
Bypass Warming Up
|
15.9 mL/kg
Standard Deviation 5.88
|
—
|
SECONDARY outcome
Timeframe: up to 6 daysOutcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Medically Significant Changes in Blood Pressure
Systolic Blood Pressure
|
75.66 mm of Hg
Standard Deviation 16.901
|
79.96 mm of Hg
Standard Deviation 16.437
|
|
Medically Significant Changes in Blood Pressure
Diastolic Blood Pressure
|
46.28 mm of Hg
Standard Deviation 10.031
|
50.00 mm of Hg
Standard Deviation 11.648
|
SECONDARY outcome
Timeframe: up to 6 daysOutcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Medically Significant Changes in Heart Rate
|
122.86 beats per minute
Standard Deviation 30.528
|
132.80 beats per minute
Standard Deviation 24.439
|
SECONDARY outcome
Timeframe: up to 6 daysOutcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Medically Significant Changes in Respiratory Rate
|
21.27 breaths/minute
Standard Deviation 7.335
|
23.79 breaths/minute
Standard Deviation 6.702
|
SECONDARY outcome
Timeframe: up to 6 daysOutcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Medically Significant Changes in Oxygen Saturation
|
96.86 % oxygen in blood
Standard Deviation 5.564
|
98.33 % oxygen in blood
Standard Deviation 3.204
|
SECONDARY outcome
Timeframe: up to 6 daysOutcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Medically Significant Changes in Body Temperature
|
35.60 units
Standard Deviation 2.023
|
36.50 units
Standard Deviation 1.597
|
SECONDARY outcome
Timeframe: up to 6 daysOutcome measures
| Measure |
Octaplas
n=50 Participants
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
Infants ≤2 Years
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|---|
|
Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor')
Assessed to have overall safety of 'excellent'
|
50 Participants
|
—
|
|
Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor')
Assessed to have overall safety of 'moderate'
|
0 Participants
|
—
|
|
Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor')
Assessed to have overall safety of 'poor'
|
0 Participants
|
—
|
Adverse Events
Octaplas
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Octaplas
n=50 participants at risk
Qualified patients will receive Octaplas as per protocol.
octaplas: Octaplas S/D Plasma
|
|---|---|
|
Vascular disorders
Portal vein thrombosis
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected for each participant over the course of 6 days
Any of the following drug safety information was collected after the start of the first infusion episode: * Serious adverse events * Adverse drug reactions temporally associated with administration of the investigational product * Adverse events that fall into the category of TEs, TEEs and hyperfibrinolytic events * Post-treatment related safety reports, pregnancies, drug overdose, interaction, abuse, misuse, medication error, lack of efficacy
|
|
Vascular disorders
Haemorrhage
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected for each participant over the course of 6 days
Any of the following drug safety information was collected after the start of the first infusion episode: * Serious adverse events * Adverse drug reactions temporally associated with administration of the investigational product * Adverse events that fall into the category of TEs, TEEs and hyperfibrinolytic events * Post-treatment related safety reports, pregnancies, drug overdose, interaction, abuse, misuse, medication error, lack of efficacy
|
|
Vascular disorders
Shock haemorrhagic
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected for each participant over the course of 6 days
Any of the following drug safety information was collected after the start of the first infusion episode: * Serious adverse events * Adverse drug reactions temporally associated with administration of the investigational product * Adverse events that fall into the category of TEs, TEEs and hyperfibrinolytic events * Post-treatment related safety reports, pregnancies, drug overdose, interaction, abuse, misuse, medication error, lack of efficacy
|
|
Surgical and medical procedures
Iatrogenic injury
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected for each participant over the course of 6 days
Any of the following drug safety information was collected after the start of the first infusion episode: * Serious adverse events * Adverse drug reactions temporally associated with administration of the investigational product * Adverse events that fall into the category of TEs, TEEs and hyperfibrinolytic events * Post-treatment related safety reports, pregnancies, drug overdose, interaction, abuse, misuse, medication error, lack of efficacy
|
|
Vascular disorders
Haemorrhage coronary artery
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected for each participant over the course of 6 days
Any of the following drug safety information was collected after the start of the first infusion episode: * Serious adverse events * Adverse drug reactions temporally associated with administration of the investigational product * Adverse events that fall into the category of TEs, TEEs and hyperfibrinolytic events * Post-treatment related safety reports, pregnancies, drug overdose, interaction, abuse, misuse, medication error, lack of efficacy
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected for each participant over the course of 6 days
Any of the following drug safety information was collected after the start of the first infusion episode: * Serious adverse events * Adverse drug reactions temporally associated with administration of the investigational product * Adverse events that fall into the category of TEs, TEEs and hyperfibrinolytic events * Post-treatment related safety reports, pregnancies, drug overdose, interaction, abuse, misuse, medication error, lack of efficacy
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected for each participant over the course of 6 days
Any of the following drug safety information was collected after the start of the first infusion episode: * Serious adverse events * Adverse drug reactions temporally associated with administration of the investigational product * Adverse events that fall into the category of TEs, TEEs and hyperfibrinolytic events * Post-treatment related safety reports, pregnancies, drug overdose, interaction, abuse, misuse, medication error, lack of efficacy
|
|
Cardiac disorders
Intracardiac thrombus
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected for each participant over the course of 6 days
Any of the following drug safety information was collected after the start of the first infusion episode: * Serious adverse events * Adverse drug reactions temporally associated with administration of the investigational product * Adverse events that fall into the category of TEs, TEEs and hyperfibrinolytic events * Post-treatment related safety reports, pregnancies, drug overdose, interaction, abuse, misuse, medication error, lack of efficacy
|
|
Cardiac disorders
Hypotension
|
2.0%
1/50 • Number of events 1 • Adverse event data were collected for each participant over the course of 6 days
Any of the following drug safety information was collected after the start of the first infusion episode: * Serious adverse events * Adverse drug reactions temporally associated with administration of the investigational product * Adverse events that fall into the category of TEs, TEEs and hyperfibrinolytic events * Post-treatment related safety reports, pregnancies, drug overdose, interaction, abuse, misuse, medication error, lack of efficacy
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place