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.