State name | Description |
---|---|
On Tx | Patients who have just experienced an acute VTE, and are receiving one of the acute treatments being evaluated (either 3, 6 or 12Â months or lifetime treatment with rivaroxaban or dual LMWH/VKA therapy) |
rVTE – DVT | Patients who have just experienced a recurrent DVT. Assigned therapy was discontinued and all patients assumed to receive 6 months of dual LMWH/VKA. The duration of utility impact was assumed to be 1 month in the base case. DVT events were not associated with excess mortality |
rVTE – PE | Patients who have just experienced a recurrent PE (± DVT). Patients with coincident DVT transit to a post-DVT state to capture PTS risk. Assigned therapy was discontinued and all patients assumed to receive 6 months of dual LMWH/VKA. The duration of utility impact was assumed to be 1 month in the base case. PE events were associated with excess mortality |
Major bleed – IC | Patients on assigned therapy who have just experienced an IC bleeding event. Therapy was temporarily withheld during the cycle in which the IC bleeding event took place. IC bleeding events were associated with excess mortality |
Major bleed – EC | Patients on assigned therapy who have just experienced a major EC bleeding event (e.g. gastrointestinal bleeding). Therapy was temporarily withheld for 1 month during the cycle in which the bleeding event took place. The duration of utility impact was assumed to be 1 month in the base case |
NMCR bleed | Patients on assigned therapy who have just experienced a NMCR bleeding event. Defined as overt bleeding that did not meet the criteria for major bleeding but was associated with medical intervention, unscheduled contact with a physician, interruption or discontinuation of a study drug, or discomfort or impairment of activities of daily life. Therapy was temporarily withheld for 1Â month during the cycle in which the bleeding event took place. An example of this would be spontaneous bleeding from gums which requires acute medical intervention. NMCR bleeding was assumed not to impact on utility |
Post-IC bleed | Patients who previously experienced an IC bleeding event. Any assigned therapy is assumed to stop. IC bleeding events are associated with major risks of residual disability stemming from their impact on the central nervous system. The health-related quality of life and costs associated with this are included |
Off Tx-post index PE* | Patients currently off treatment after index PE. These patients are not at ongoing risk of PTS |
Off Tx-post DVT | Patients who have experienced an incident DVT within the time frame of the model and who are currently off treatment. These patients are at risk of PTS |
On Tx-post DVT | This state is only applicable to analyses of lifelong treatment duration. Patients who have experienced an incident DVT within the time frame of the model and who are currently on treatment. These patients are at risk of PTS |
PE post DVT* | Patients with recurrent PE and a history of DVT within the model. Survivors return to relevant post-DVT states so as to continue exposure to a risk of PTS conferred by their DVT history |
CTEPH | Patients diagnosed with CTEPH who are exposed to management costs, health-related quality of life loss and excess mortality |
Long-term CTEPH | State to which patients with CTEPH transition in the long term |
Death | Terminal state. Patients could die because of either events captured in the model, such as PE or IC bleed, or from other causes |