Study: NCT03702244

Adverse event: Myocardial Infarction (MI - non-fatal)
Serious: yes
Organ System: Cardiac disorders
Notes: Acute MI was defined as having evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Fatal MI is excluded. The Fourth Universal Definition of MI was used.
Frequency: 13 affected / 1057 at risk

Adverse event: Death from any cause
Serious: yes
Organ System: Cardiac disorders
Notes: All cause death is defined as death resulting from any cause.
Frequency: 5 affected / 1057 at risk

Adverse event: Unplanned CV hospitalization excluding admissions with MI or death
Serious: yes
Organ System: Cardiac disorders
Notes: Unplanned cardiovascular (CV) admissions to hospital without MI or death during the same episode of care. Statistical testing for recurrent events was performed using the negative binomial methods for recurrent events.
Frequency: 22 affected / 1057 at risk

Adverse event: Major test and procedural complications by test type
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: There were no specific safety events associated with investigative procedures in this trial. All complications occurring (during the cardiovascular test as per protocol) were categorized in two groups (1) Major and (2) Minor, and by test type.
Frequency: 4 affected / 1057 at risk

Adverse event: Minor test and procedural complications by test type
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: There were no specific safety events associated with investigative procedures in this trial. All complications occurring (during the cardiovascular test as per protocol) were categorized in two groups (1) Major and (2) Minor, and by test type.
Frequency: 9 affected / 1057 at risk

Adverse event: Myocardial Infarction (MI - non-fatal)
Serious: yes
Organ System: Cardiac disorders
Notes: Acute MI was defined as having evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Fatal MI is excluded. The Fourth Universal Definition of MI was used.
Frequency: 5 affected / 1046 at risk

Adverse event: Death from any cause
Serious: yes
Organ System: Cardiac disorders
Notes: All cause death is defined as death resulting from any cause.
Frequency: 7 affected / 1046 at risk

Adverse event: Unplanned CV hospitalization excluding admissions with MI or death
Serious: yes
Organ System: Cardiac disorders
Notes: Unplanned cardiovascular (CV) admissions to hospital without MI or death during the same episode of care. Statistical testing for recurrent events was performed using the negative binomial methods for recurrent events.
Frequency: 18 affected / 1046 at risk

Adverse event: Major test and procedural complications by test type
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: There were no specific safety events associated with investigative procedures in this trial. All complications occurring (during the cardiovascular test as per protocol) were categorized in two groups (1) Major and (2) Minor, and by test type.
Frequency: 6 affected / 1046 at risk

Adverse event: Minor test and procedural complications by test type
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: There were no specific safety events associated with investigative procedures in this trial. All complications occurring (during the cardiovascular test as per protocol) were categorized in two groups (1) Major and (2) Minor, and by test type.
Frequency: 37 affected / 1046 at risk