Type of Adverse Event | QW (n = 374) n (%) | EDS (n = 378) n (%) |
---|---|---|
Patients who had any adverse events | 357 (95) | 360 (95) |
Patients who had adverse events of historical interest | 106 (28) | 100 (26) |
Neoplasms benign, malignant and unspecified | 59 (16) | 54 (14) |
Embolism/thrombosis | 23 (6) | 21 (6) |
Deep vein thrombosis | 14 (4) | 9 (2) |
Pulmonary embolism | 2 (1) | 9 (2) |
Phlebitis | 2 (1) | 2 (1) |
Jugular vein thrombosis | 0 (0) | 1 (<1) |
Subclavian vein thrombosis | 0 (0) | 1 (<1) |
Superior vena caval occlusion | 0 (0) | 1 (<1) |
Thrombophlebitis superficial | 2 (1) | 1 (<1) |
Thrombosis | 2 (1) | 1 (<1) |
Atrial thrombosis | 1 (<1) | 0 (0) |
Phlebitis superficial | 1 (<1) | 0 (0) |
Arrhythmias | 19 (5) | 12 (3) |
Congestive heart failure | 12 (3) | 10 (3) |
Hypertension | 10 (3) | 9 (2) |
Cerebrovascular accident | 2 (1) | 7 (2) |
Myocardial infarction/coronary artery disorders | 4 (1) | 5 (1) |
Immune system disorders | 0 (0) | 3 (1) |
Seizure | 3 (1) | 2 (1) |
Patients who had treatment-related adverse events | 18 (5) | 14 (4) |
Patients who had serious adverse events | 154 (41) | 133 (35) |
Patients who had serious treatment-related adverse events | 2 (1) | 3 (1) |
Pulmonary embolism | 0 (0) | 2 (1) |
Arthralgia | 0 (0) | 1 (<1) |
Neutropenia | 1 (<1) | 0 (0) |
Myocardial infarction | 1 (<1) | 0 (0) |
Pyrexia | 1 (<1) | 0 (0) |
Patients who had life-threatening adverse events | 22 (6) | 16 (4) |
Patients who discontinued from the study because of adverse events | 58 (16) | 46 (12) |
Patients who died | 39 (10) | 39 (10) |