Table 1 Overall incidence of thrombotic and bleeding adverse events (treated patients)
Study 1 (mCRC) a | Study 2 (mCRC) | Study 3 (NSCLC) b | ||||
|---|---|---|---|---|---|---|
Adverse event | IFL/placebo ( n =397) | IFL/BV ( n =392) | FOLFOX-4/XELOX/ placebo ( n =675) | FOLFOX-4/XELOX/ BV ( N =694) | CG/placebo ( n =327) | CG/BV ( n =659) b |
Patients with any grade events, n (%) | ||||||
Arterial thrombosis | 5 (1.3) | 14 (3.6) | 10 (1.5) | 17 (2.4) | 18 (5.5) | 25 (3.8) |
Venous thrombosis | 62 (15.6) | 68 (17.3) | 65 (9.6) | 94 (13.5) | 35 (10.7) | 85 (12.9) |
Bleeding/haemorrhage | NAa | NAa | 175 (25.9) | 212 (30.5) | 67 (20.5) | 239 (36.3) |
Patients with grade 3/4 events, n (%) | ||||||
Venous thrombosis | 55 (13.8) | 60 (15.3) | 34 (5.0) | 56 (8.1) | 21 (6.4) | 47 (7.1) |
Deep vein thrombosis | 27 (6.8) | 35 (8.9) | 10 (1.5) | 21 (3.0) | 5 (1.5) | 13 (2.0) |
Pulmonary embolus | 20 (5.0) | 15 (3.8) | 7 (1.0) | 18 (2.6) | 10 (3.1) | 26 (3.9) |
Bleeding/haemorrhage | 10 (2.5) | 13 (3.3) | 8 (1.2) | 13 (1.9) | 4 (1.2) | 23 (3.5) |
