Trial Outcomes & Findings for A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI) (NCT NCT01347580)
NCT ID: NCT01347580
Last Updated: 2015-07-22
Results Overview
(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1875 participants
Primary outcome timeframe
At initial angiography, pre PCI
Results posted on
2015-07-22
Participant Flow
Patients were randomized in pre-hospital settings at 102 Emergency Medical Services between September 2011 and October 2013. 1875 patients were recruited in the study, 1862 consented patients were randomized.
Participant milestones
| Measure |
Pre-hospital Ticagrelor
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Overall Study
STARTED
|
909
|
953
|
|
Overall Study
Modified Intent to Treat Population
|
906
|
952
|
|
Overall Study
Safety Population
|
908
|
950
|
|
Overall Study
COMPLETED
|
844
|
897
|
|
Overall Study
NOT COMPLETED
|
65
|
56
|
Reasons for withdrawal
| Measure |
Pre-hospital Ticagrelor
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
23
|
|
Overall Study
Death
|
30
|
19
|
|
Overall Study
Protocol Violation
|
10
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Had other reason
|
9
|
6
|
Baseline Characteristics
A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI)
Baseline characteristics by cohort
| Measure |
Pre-hospital Ticagrelor
n=909 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=953 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
Total
n=1862 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Years
|
60.6 Years
STANDARD_DEVIATION 12.38 • n=5 Participants
|
61.0 Years
STANDARD_DEVIATION 12.49 • n=7 Participants
|
60.8 Years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
369 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
736 Participants
n=5 Participants
|
757 Participants
n=7 Participants
|
1493 Participants
n=5 Participants
|
|
Diabetes mellitus
yes
|
115 patients
n=5 Participants
|
138 patients
n=7 Participants
|
253 patients
n=5 Participants
|
|
Diabetes mellitus
no/unknown
|
794 patients
n=5 Participants
|
815 patients
n=7 Participants
|
1609 patients
n=5 Participants
|
|
TIMI risk score
0-2
|
552 patients
n=5 Participants
|
573 patients
n=7 Participants
|
1125 patients
n=5 Participants
|
|
TIMI risk score
3-6
|
337 patients
n=5 Participants
|
365 patients
n=7 Participants
|
702 patients
n=5 Participants
|
|
TIMI risk score
>6
|
20 patients
n=5 Participants
|
15 patients
n=7 Participants
|
35 patients
n=5 Participants
|
|
Killip class
I
|
819 patients
n=5 Participants
|
862 patients
n=7 Participants
|
1681 patients
n=5 Participants
|
|
Killip class
II, III, IV
|
51 patients
n=5 Participants
|
43 patients
n=7 Participants
|
94 patients
n=5 Participants
|
|
Killip class
unknown
|
39 patients
n=5 Participants
|
48 patients
n=7 Participants
|
87 patients
n=5 Participants
|
|
First medical contact
in ambulance
|
689 patients
n=5 Participants
|
723 patients
n=7 Participants
|
1412 patients
n=5 Participants
|
|
First medical contact
in emergency department
|
220 patients
n=5 Participants
|
230 patients
n=7 Participants
|
450 patients
n=5 Participants
|
|
PCI
yes
|
800 Patients
n=5 Participants
|
830 Patients
n=7 Participants
|
1630 Patients
n=5 Participants
|
|
PCI
no
|
109 Patients
n=5 Participants
|
123 Patients
n=7 Participants
|
232 Patients
n=5 Participants
|
|
type of PCI
with stent
|
760 patients
n=5 Participants
|
776 patients
n=7 Participants
|
1536 patients
n=5 Participants
|
|
type of PCI
without stent
|
40 patients
n=5 Participants
|
54 patients
n=7 Participants
|
94 patients
n=5 Participants
|
|
Time between the 2 loading doses
|
32 minutes
n=5 Participants
|
30 minutes
n=7 Participants
|
31 minutes
n=5 Participants
|
PRIMARY outcome
Timeframe: At initial angiography, pre PCIPopulation: mITT, on patients with non missing values
(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=824 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=856 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)
|
143 patients
|
145 patients
|
PRIMARY outcome
Timeframe: Between baseline and PCIPopulation: mITT, on patients with non missing values
ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (\<70%) resolution.
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=774 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=824 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)
|
102 patients
|
102 patients
|
SECONDARY outcome
Timeframe: during the 30 days of treatmentPopulation: mITT
death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=906 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=952 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
1st Composite Clinical Endpoint
|
41 patients
|
42 patients
|
SECONDARY outcome
Timeframe: within 30 days of studyPopulation: mITT
Death/MI/urgent revascularization. Adjudicated events except death
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=906 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=952 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
2nd Composite Clinical Endpoint
|
39 patients
|
34 patients
|
SECONDARY outcome
Timeframe: during 30 days of treatmentPopulation: mITT
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=906 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=952 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Definite Stent Thrombosis
|
2 patients
|
11 patients
|
SECONDARY outcome
Timeframe: at coroangiography post-PCIPopulation: mITT, on patients with non missing TIMI flow grade values
TIMI) flow grade 3 is complete perfusion post-PCI.
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=760 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=784 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
TIMI Flow Grade 3 Post -PCI
|
625 patients
|
630 patients
|
SECONDARY outcome
Timeframe: Between baseline and ECG 60 mn post-PCIPopulation: mITT on patients with non missing ECG values
ST segment elevation resolution post PCI \>=70% is defined as complete resolution
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=713 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=743 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
ST Segment Elevation Resolution Post-PCI >= 70%
|
410 patients
|
390 patients
|
SECONDARY outcome
Timeframe: during PCIPopulation: mITT
Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=906 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=952 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI
|
78 patients
|
100 patients
|
SECONDARY outcome
Timeframe: within 48 hours of first dosePopulation: Safety
non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=908 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=950 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Major Bleeds Within 48 Hours
|
16 patients
|
15 patients
|
SECONDARY outcome
Timeframe: within 48 hours of first dosePopulation: Safety
non CABG related bleeds (PLATO definition)
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=908 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=950 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Minor and Major Bleedings Within 48 Hours
|
24 patients
|
24 patients
|
SECONDARY outcome
Timeframe: after 48hours post-first dosePopulation: safety
non CABG related bleeds (PLATO definition) include life threatening and other major bleedings
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=908 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=950 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Major Bleeds After 48 Hours
|
11 patients
|
11 patients
|
SECONDARY outcome
Timeframe: after 48 hours post first dosePopulation: safety
non CABG related bleeds (PLATO definition)
Outcome measures
| Measure |
Pre-hospital Ticagrelor
n=908 Participants
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
In-hospital Ticagrelor
n=950 Participants
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Minor and Major Bleeds After 48 Hours
|
18 patients
|
16 patients
|
Adverse Events
Ticagrelor In-Hosp
Serious events: 143 serious events
Other events: 529 other events
Deaths: 0 deaths
Ticagrelor Pre-Hosp
Serious events: 140 serious events
Other events: 469 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ticagrelor In-Hosp
n=950 participants at risk
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
Ticagrelor Pre-Hosp
n=908 participants at risk
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADRENAL ADENOMA
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER NEOPLASM
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARDIAC MYXOMA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE)
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL NEOPLASM
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER METASTATIC
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
DIZZINESS
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
DYSARTHRIA
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
HEMIPARESIS
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
LACUNAR INFARCTION
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.32%
3/950 • Number of events 3 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Psychiatric disorders
ANXIETY
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Renal and urinary disorders
RENAL COLIC
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.32%
3/950 • Number of events 3 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.33%
3/908 • Number of events 3 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
DIAPHRAGMATIC PARALYSIS
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.44%
4/908 • Number of events 4 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Vascular disorders
AORTIC DISSECTION
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Vascular disorders
ARTERY DISSECTION
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Vascular disorders
HAEMODYNAMIC INSTABILITY
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Vascular disorders
HYPOTENSION
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.33%
3/908 • Number of events 3 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
AORTIC VALVE INCOMPETENCE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
ARRHYTHMIA
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
ARTERIOSPASM CORONARY
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.44%
4/908 • Number of events 4 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.32%
3/950 • Number of events 3 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
BRADYCARDIA
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
CARDIAC ARREST
|
0.74%
7/950 • Number of events 7 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
1.2%
11/908 • Number of events 11 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
CARDIAC ASTHMA
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.74%
7/950 • Number of events 7 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.77%
7/908 • Number of events 7 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
1.7%
16/950 • Number of events 16 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
1.9%
17/908 • Number of events 17 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
CONGESTIVE CARDIOMYOPATHY
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
DRESSLER'S SYNDROME
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
INTERVENTRICULAR SEPTUM RUPTURE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
INTRACARDIAC THROMBUS
|
0.42%
4/950 • Number of events 4 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
MYOCARDIAL RUPTURE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
PALPITATIONS
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.42%
4/950 • Number of events 4 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
PERICARDITIS
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
TORSADE DE POINTES
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
VENTRICLE RUPTURE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
3.2%
30/950 • Number of events 30 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
2.5%
23/908 • Number of events 23 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
VENTRICULAR SEPTAL DEFECT ACQUIRED
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.74%
7/950 • Number of events 7 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.66%
6/908 • Number of events 6 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Congenital, familial and genetic disorders
VENTRICULAR SEPTAL DEFECT
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
COLITIS
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
GASTRITIS
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
GASTROINTESTINAL TELANGIECTASIA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
MELAENA
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMATOMA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
ASTHENIA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
CARDIAC DEATH
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
CHEST PAIN
|
0.42%
4/950 • Number of events 4 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
DEVICE MALFUNCTION
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.53%
5/950 • Number of events 5 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.44%
4/908 • Number of events 4 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
SUDDEN CARDIAC DEATH
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
SUDDEN DEATH
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
THROMBOSIS IN DEVICE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
VESSEL PUNCTURE SITE HAEMATOMA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
BILIARY SEPSIS
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
GROIN INFECTION
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
LUNG INFECTION
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
PNEUMONIA
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
RELAPSING FEVER
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
SEPSIS
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.21%
2/950 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Injury, poisoning and procedural complications
PROCEDURAL HAEMORRHAGE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.33%
3/908 • Number of events 3 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Investigations
NUTRITIONAL CONDITION ABNORMAL
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Investigations
TROPONIN INCREASED
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.22%
2/908 • Number of events 2 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.11%
1/908 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.11%
1/950 • Number of events 1 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
0.00%
0/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
Other adverse events
| Measure |
Ticagrelor In-Hosp
n=950 participants at risk
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
Ticagrelor Pre-Hosp
n=908 participants at risk
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
|
|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
8.5%
81/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
8.7%
79/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
Dyspnoea
|
9.1%
86/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
6.8%
62/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
Nausea
|
5.2%
49/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
4.5%
41/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
General disorders
Non cardiac chest pain
|
5.5%
52/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
4.6%
42/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Vascular disorders
Hypotension
|
3.2%
30/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
4.8%
44/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.7%
26/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
3.1%
28/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Nervous system disorders
Headache
|
3.3%
31/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
2.1%
19/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
40/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
3.7%
34/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
38/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
3.3%
30/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
Ventricular fibrillation
|
3.9%
37/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
3.5%
32/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
Cardiac failure
|
3.5%
33/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
3.3%
30/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
|
Cardiac disorders
Bradycardia
|
2.7%
26/950 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
3.1%
28/908 • within 30 days of study
Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60