Table 2

List of trial estimands with definitions

EstimandDefinition
Primary outcome
E1All-cause mortality
Difference (aspirin minus LMWH) in the probability of dying of any cause
Secondary efficacy outcomes
Cause-specific mortality
E2Difference in the probability of being observed to die due to PE (adjudication categories a and b) under assigned treatment
E3Difference in the probability of being observed to die due to PE (adjudication categories a, b and c)
E4Difference in the probability of being observed to die due to non-PE (categories d or e) related causes of death
Non-fatal pulmonary embolism
E5.1Difference in the probability of being observed to have a non-fatal PE
E5.2Difference in the probability of being observed to have a massive non-fatal PE
E5.3Difference in the probability of being observed to have a submassive non-fatal PE
E5.4Difference in the probability of being observed to have a clinically significant non-fatal PE
E5.5Difference in the probability of being observed to have a clinically non-significant non-fatal PE
E5.6Difference in the probability of being observed to have a segmental non-fatal PE
E5.7Difference in the probability of being observed to have a non-segmental non-fatal PE
Deep vein thrombosis
E6.1Difference in the probability of being observed to have symptomatic deep vein thrombosis
E6.2Difference in the probability of being observed to have proximal deep vein thrombosis
E6.3Difference in the probability of being observed to have distal deep vein thrombosis
Secondary safety outcomes
E7Bleeding event
Difference in the probability of being observed to have a bleeding event
E8Wound complication
Difference in the probability of being observed to have a wound complication
E9Deep 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.