Trial Outcomes & Findings for STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction (NCT NCT00623623)
NCT ID: NCT00623623
Last Updated: 2019-08-01
Results Overview
The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1899 participants
Primary outcome timeframe
30 days
Results posted on
2019-08-01
Participant Flow
Open-label, prospective, randomised, parallel, comparative international multicentre trial
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.
Participant milestones
| Measure |
Tenecteplase (Group A)
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
950
|
949
|
|
Overall Study
COMPLETED
|
949
|
948
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Tenecteplase (Group A)
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Overall Study
Previous enrolment into this study
|
1
|
1
|
Baseline Characteristics
FAS
Baseline characteristics by cohort
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
Total
n=1897 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 Years
STANDARD_DEVIATION 12.42 • n=949 Participants • FAS
|
60 Years
STANDARD_DEVIATION 12.49 • n=948 Participants • FAS
|
60 Years
STANDARD_DEVIATION 12.46 • n=1897 Participants • FAS
|
|
Sex: Female, Male
Female
|
195 Participants
n=949 Participants • FAS
|
208 Participants
n=948 Participants • FAS
|
403 Participants
n=1897 Participants • FAS
|
|
Sex: Female, Male
Male
|
754 Participants
n=949 Participants • FAS
|
740 Participants
n=948 Participants • FAS
|
1494 Participants
n=1897 Participants • FAS
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Full analysis set (FAS): All consented patients either randomised by Interactive Voice Response System (IVRS) or treated (i.e., manually allocated to treatment group) by the investigator. This population is also referred to as the intention-to-treat population (ITT).
The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS).
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.
|
116 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported.
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With All Cause Mortality
|
43 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported.
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Cardiac Mortality
|
31 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported.
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Cardiogenic Shock
|
41 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported.
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Congestive Heart Failure (CHF)
|
57 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Recurrent Myocardial Infarction (Reinfarction)
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Rehospitalisation for Cardiac Reasons
|
45 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Rehospitalisation for Non-cardiac Reasons
|
19 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Serious Repeat Target Vessel Revascularization
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With All Cause Death and Shock
|
59 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported.
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With All Cause Death and Shock and CHF
|
100 Participants
|
123 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With All Cause Death and Shock and Reinfarction
|
77 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Total Fatal Stroke
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Total Disabling Stroke
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Total Non-disabling Stroke
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Intracranial Haemorrhage
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Ischaemic Stroke
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Total Stroke (All Types)
|
15 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions
|
61 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Minor Non-intracranial Bleeds
|
206 Participants
|
191 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Total Non-intracranial Bleeds
|
267 Participants
|
236 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Serious Resuscitated Ventricular Fibrillation
|
32 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures
|
10 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With All Cause Death and Non-fatal Stroke
|
50 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: FAS
This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported
Outcome measures
| Measure |
Tenecteplase (Group A)
n=949 Participants
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 Participants
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke
|
117 Participants
|
135 Participants
|
Adverse Events
Tenecteplase (Group A)
Serious events: 146 serious events
Other events: 0 other events
Deaths: 43 deaths
Primary PCI (Group B)
Serious events: 164 serious events
Other events: 0 other events
Deaths: 42 deaths
Serious adverse events
| Measure |
Tenecteplase (Group A)
n=949 participants at risk
Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment)
|
Primary PCI (Group B)
n=948 participants at risk
Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines.
|
|---|---|---|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Angina pectoris
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Angina unstable
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Arteriospasm coronary
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.42%
4/949 • From first drug administration until end of tiral, up to 30 days
|
1.2%
11/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Atrioventricular block
|
0.95%
9/949 • From first drug administration until end of tiral, up to 30 days
|
1.5%
14/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Bradycardia
|
0.32%
3/949 • From first drug administration until end of tiral, up to 30 days
|
0.42%
4/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
10/949 • From first drug administration until end of tiral, up to 30 days
|
1.7%
16/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Cardiac failure acute
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Cardiac tamponade
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.21%
2/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Coronary artery dissection
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Coronary artery occlusion
|
0.32%
3/949 • From first drug administration until end of tiral, up to 30 days
|
0.84%
8/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Coronary artery perforation
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Intracardiac thrombus
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Mitral valve incompetence
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.32%
3/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.53%
5/949 • From first drug administration until end of tiral, up to 30 days
|
0.21%
2/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Myocardial rupture
|
0.53%
5/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Parasystole
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Pericardial effusion
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.42%
4/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Pericarditis
|
0.95%
9/949 • From first drug administration until end of tiral, up to 30 days
|
0.74%
7/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Postinfarction angina
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Pulseless electrical activity
|
0.53%
5/949 • From first drug administration until end of tiral, up to 30 days
|
0.32%
3/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Sinus arrhythmia
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Torsade de pointes
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Ventricular fibrillation
|
4.3%
41/949 • From first drug administration until end of tiral, up to 30 days
|
4.9%
46/948 • From first drug administration until end of tiral, up to 30 days
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
11/949 • From first drug administration until end of tiral, up to 30 days
|
1.4%
13/948 • From first drug administration until end of tiral, up to 30 days
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Gastrointestinal disorders
Ileus
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.21%
2/948 • From first drug administration until end of tiral, up to 30 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
General disorders
Chest pain
|
0.42%
4/949 • From first drug administration until end of tiral, up to 30 days
|
0.42%
4/948 • From first drug administration until end of tiral, up to 30 days
|
|
General disorders
Device occlusion
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.21%
2/948 • From first drug administration until end of tiral, up to 30 days
|
|
General disorders
Multi-organ failure
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.21%
2/948 • From first drug administration until end of tiral, up to 30 days
|
|
General disorders
Necrosis
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
General disorders
Non-cardiac chest pain
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
General disorders
Pyrexia
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
General disorders
Systemic inflammatory response syndrome
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
General disorders
Thrombosis in device
|
0.32%
3/949 • From first drug administration until end of tiral, up to 30 days
|
0.42%
4/948 • From first drug administration until end of tiral, up to 30 days
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Endocarditis
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Infection
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Lower respiratory tract infection
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Mediastinitis
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Pneumonia
|
0.74%
7/949 • From first drug administration until end of tiral, up to 30 days
|
0.53%
5/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Sepsis
|
0.32%
3/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Septic shock
|
0.32%
3/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Sputum purulent
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Toxic shock syndrome
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Urinary tract infection
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Infections and infestations
Wound infection
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Investigations
Blood electrolytes abnormal
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Investigations
C-reactive protein increased
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Investigations
Electrocardiogram abnormal
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Investigations
International normalised ratio increased
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Investigations
Pulse absent
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage IV
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Coma
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Convulsion
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Headache
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Loss of consciousness
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Neuromyopathy
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.21%
2/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Psychiatric disorders
Delirium
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Renal and urinary disorders
Renal failure
|
0.32%
3/949 • From first drug administration until end of tiral, up to 30 days
|
0.42%
4/948 • From first drug administration until end of tiral, up to 30 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.32%
3/949 • From first drug administration until end of tiral, up to 30 days
|
0.53%
5/948 • From first drug administration until end of tiral, up to 30 days
|
|
Renal and urinary disorders
Renal impairment
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.21%
2/948 • From first drug administration until end of tiral, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
11/949 • From first drug administration until end of tiral, up to 30 days
|
1.5%
14/948 • From first drug administration until end of tiral, up to 30 days
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.21%
2/948 • From first drug administration until end of tiral, up to 30 days
|
|
Surgical and medical procedures
Mechanical ventilation
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.00%
0/948 • From first drug administration until end of tiral, up to 30 days
|
|
Surgical and medical procedures
Resuscitation
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Vascular disorders
Aortic dissection
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.21%
2/948 • From first drug administration until end of tiral, up to 30 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
|
Vascular disorders
Hypotension
|
0.21%
2/949 • From first drug administration until end of tiral, up to 30 days
|
0.42%
4/948 • From first drug administration until end of tiral, up to 30 days
|
|
Vascular disorders
Peripheral ischaemia
|
0.11%
1/949 • From first drug administration until end of tiral, up to 30 days
|
0.11%
1/948 • From first drug administration until end of tiral, up to 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
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Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER