Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
VTE recurrence event Venous thromboembolism (VTE) recurrence event |
VTE recurrence event is defined as pulmonary embolism (PE) and/or deep vein thrombosis (DVT) by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. |
18 months |
|
Secondary |
Major bleeding event (ISTH criteria) |
Major bleeding is defined as International Society of Thrombosis and Hemostasis (ISTH) major bleeding, which consisted of a reduction in the hemoglobin level by at least 2 g/dL, transfusion of at least 2 units of blood or symptomatic bleeding in a critical area or organ. |
3 months |
|
Secondary |
PE-related death event |
PE-related death event is defined as death due to a documented PE (either an objective test prior to death of the subject or PE detected during autopsy) or unexplained death (i.e. death without a clear alternate cause and not a primary consequence of subject's underlying cancer). |
3 months |
|
Secondary |
A composite of PE-related death, symptomatic recurrent VTE, and major bleeding (ISTH criteria) |
PE-related death event is defined as death due to a documented PE or unexplained death. Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. Major bleeding is defined as International Society of Thrombosis and Hemostasis (ISTH) major bleeding, which consisted of a reduction in the hemoglobin level by at least 2 g/dL, transfusion of at least 2 units of blood or symptomatic bleeding in a critical area or organ. |
3 months |
|
Secondary |
Symptomatic VTE recurrence event |
Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. |
3 months |
|
Secondary |
Hospitalization for VTE recurrence or clinically relevant bleeding events |
Hospitalization for VTE recurrence or bleeding events. VTE recurrence event is defined as PE and/or DVT by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. Bleeding events are clinically relevant bleeding events, which is defined as major or clinically relevant non-major bleeding. Major bleeding is defined as International Society of Thrombosis and Hemostasis (ISTH) major bleeding, which consisted of a reduction in the hemoglobin level by at least 2 g/dL, transfusion of at least 2 units of blood or symptomatic bleeding in a critical area or organ. Clinically relevant non-major bleeding event is defined as overt bleeding (i.e. is symptomatic or visualized by examination) which is not meeting the criteria for major bleeding, requires medical attention or is associated with discomfort for the subject such as pain, or impairment of activities of daily life. |
3 months |
|
Secondary |
Major bleeding event (ISTH criteria) |
Major bleeding is defined as International Society of Thrombosis and Hemostasis (ISTH) major bleeding, which consisted of a reduction in the hemoglobin level by at least 2 g/dL, transfusion of at least 2 units of blood or symptomatic bleeding in a critical area or organ. |
18 months |
|
Secondary |
PE-related death event |
PE-related death event is defined as death due to a documented PE (either an objective test prior to death of the subject or PE detected during autopsy) or unexplained death (i.e. death without a clear alternate cause and not a primary consequence of subject's underlying cancer). |
18 months |
|
Secondary |
Symptomatic VTE recurrence event |
Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. |
18 months |
|
Secondary |
Clinically relevant non-major (CRNM) bleeding |
A bleeding event will be classified as a clinically relevant non-major bleeding event if it is overt (i.e. is symptomatic or visualized by examination) not meeting the criteria for major bleeding, requires medical attention or is associated with discomfort for the subject such as pain, or impairment of activities of daily life. |
18 months |
|
Secondary |
Clinically relevant bleeding |
Clinically relevant bleeding is defined as major or CRNM bleeding. |
18 months |
|
Secondary |
All-cause death |
Death from any cause. |
18 months |
|
Secondary |
Bleeding-related death event |
Bleeding-related death event is defined as a bleeding event directly led to death. Examples of fatal bleeding events are an intracranial hemorrhage that led to herniation of the brain and death within 24 hours, and a massive gastrointestinal hemorrhage that results in shock, hemodynamic collapse, and death. |
18 months |
|
Secondary |
Any adverse outcomes during invasive procedures |
Adverse outcomes include bleeding events, recurrent VTE events, all-cause deaths. |
18 months |
|