List of trial estimands with definitions
Estimand | Definition |
Primary outcome | |
E1 | All-cause mortality |
Difference (aspirin minus LMWH) in the probability of dying of any cause | |
Secondary efficacy outcomes | |
Cause-specific mortality | |
E2 | Difference in the probability of being observed to die due to PE (adjudication categories a and b) under assigned treatment |
E3 | Difference in the probability of being observed to die due to PE (adjudication categories a, b and c) |
E4 | Difference in the probability of being observed to die due to non-PE (categories d or e) related causes of death |
Non-fatal pulmonary embolism | |
E5.1 | Difference in the probability of being observed to have a non-fatal PE |
E5.2 | Difference in the probability of being observed to have a massive non-fatal PE |
E5.3 | Difference in the probability of being observed to have a submassive non-fatal PE |
E5.4 | Difference in the probability of being observed to have a clinically significant non-fatal PE |
E5.5 | Difference in the probability of being observed to have a clinically non-significant non-fatal PE |
E5.6 | Difference in the probability of being observed to have a segmental non-fatal PE |
E5.7 | Difference in the probability of being observed to have a non-segmental non-fatal PE |
Deep vein thrombosis | |
E6.1 | Difference in the probability of being observed to have symptomatic deep vein thrombosis |
E6.2 | Difference in the probability of being observed to have proximal deep vein thrombosis |
E6.3 | Difference in the probability of being observed to have distal deep vein thrombosis |
Secondary safety outcomes | |
E7 | Bleeding event |
Difference in the probability of being observed to have a bleeding event | |
E8 | Wound complication |
Difference in the probability of being observed to have a wound complication | |
E9 | Deep surgical site infection |
Difference in the probability of being observed to have a deep surgical site infection. |
LMWH, low-molecular-weight heparin; PE, pulmonary embolism.