TABLE A6.
Venous Thromboembolic and Bleeding Events by Anticoagulation Use Across All Study Patients
| Event | Any Prophylactic Anticoagulation (n = 335), No. (%) | No Prophylactic Anticoagulation (n = 81), No. (%) |
|---|---|---|
| Any venous thromboembolic event | 32 (10) | 17 (21) |
| Grade 1 | 5 (1) | 3 (4) |
| Grade 2 | 23 (7) | 9 (11) |
| Grade 3 to 4 | 4 (1) | 5 (6) |
| Grade 5 | 0 | 0 |
| Any venous thromboembolic event leading to death | 0 | 0 |
| Any venous thromboembolic event leading to discontinuation of any agent | 0 | 2 (2) |
| Venous thromboembolic eventsa | ||
| Deep vein thrombosis | 11 (3) | 5 (6) |
| Pulmonary embolism | 10 (3) | 5 (6) |
| Venous thrombosis limb | 4 (1) | 2 (2) |
| Venous embolism | 4 (1) | 2 (2) |
| Embolism | 3 (0.9) | 2 (2) |
| Venous thrombosis | 2 (0.6) | 1 (1) |
| Thrombosis | 2 (0.6) | 1 (1) |
| Subclavian vein thrombosis | 1 (0.3) | 0 |
| Pulmonary infarction | 0 | 1 (1) |
| Superficial vein thrombosis | 0 | 1 (1) |
| Any bleeding event | 92 (27) | 10 (12) |
| Grade 3 to 4b | 4 (1) | 1 (1) |
| Grade 5 | 0 | 0 |
| Any bleeding event leading to death | 0 | 0 |
| Any bleeding event leading to discontinuation of any agent | 1 (0.3) | 0 |
NOTE. The safety population included all the patients who were randomly assigned and received at least one dose of any trial treatment. The group with any prophylactic anticoagulation included patients who had anticoagulation before at Cycle 1 Day 1 plus a 3-day window and continued until disease progression, death, withdrawal from the study, occurrence of venous thromboembolism, or Cycle 5 Day 1. The group with no prophylactic anticoagulation included patients who never took prophylactic anticoagulation during the first 4 months of amivantamab and lazertinib combination treatment.
Events in this category are listed according to decreasing incidence in the prophylactic anticoagulation group.
Grade 3 to 4 events include contusion, gingival bleeding, hemoptysis, hematemesis, and nail bed bleeding.