TABLE A5.
Event | Subcutaneous Group (n = 206), No. (%) | Intravenous Group (n = 210), No. (%) | ||
---|---|---|---|---|
Any Prophylactic Anticoagulation (n = 164) | No Prophylactic Anticoagulation (n = 42) | Any Prophylactic Anticoagulation (n = 171) | No Prophylactic Anticoagulation (n = 39) | |
Any venous thromboembolic event | 12 (7) | 7 (17) | 20 (12) | 10 (26) |
Grade 1 | 0 | 1 (2) | 5 (3) | 2 (5) |
Grade 2 | 10 (6) | 6 (14) | 13 (8) | 3 (8) |
Grade 3 to 4 | 2 (1) | 0 | 2 (1) | 5 (13) |
Grade 5 | 0 | 0 | 0 | 0 |
Any venous thromboembolic event leading to death | 0 | 0 | 0 | 0 |
Any venous thromboembolic event leading to discontinuation of any agent | 0 | 0 | 0 | 2 (5) |
Venous thromboembolic eventsa | ||||
Pulmonary embolism | 4 (2) | 2 (5) | 6 (4) | 3 (8) |
Deep vein thrombosis | 3 (2) | 2 (5) | 8 (5) | 3 (8) |
Venous embolism | 2 (1) | 1 (2) | 2 (1) | 1 (3) |
Venous thrombosis limb | 3 (2) | 0 | 1 (0.6) | 2 (5) |
Embolism | 1 (0.6) | 1 (2) | 2 (1) | 1 (3) |
Thrombosis | 1 (0.6) | 1 (2) | 1 (0.6) | 0 |
Subclavian vein thrombosis | 1 (0.6) | 0 | 0 | 0 |
Superficial vein thrombosis | 0 | 1 (2) | 0 | 0 |
Venous thrombosis | 0 | 0 | 2 (1) | 1 (3) |
Pulmonary infarction | 0 | 0 | 0 | 1 (3) |
Any bleeding event | 44 (27) | 5 (12) | 48 (28) | 5 (13) |
Grade 3 to 4b | 3 (2) | 1 (2) | 1 (0.6) | 0 |
Grade 5 | 0 | 0 | 0 | 0 |
Any bleeding event leading to death | 0 | 0 | 0 | 0 |
Any bleeding event leading to discontinuation of any agent | 1 (0.6) | 0 | 0 | 0 |
NOTE. The safety population included all patients who had undergone random assignment and received at least one dose of any trial treatment. The group with any prophylactic anticoagulation included patients who had anticoagulation before or 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.
Events in this category are listed according to decreasing incidence in the subcutaneous group.
Grade 3 to 4 events include contusion, gingival bleeding, hemoptysis, hematemesis, and nail bed bleeding.