Hemorrhagic adverse events by system organ class in cycle 1
| System organ class . | Test (n = 52), no. (%) . | Reference (n = 51), no. (%) . | ||
|---|---|---|---|---|
| Total . | Severe . | Total . | Severe . | |
| Any hemorrhagic event | 41 (79) | 3 (6) | 38 (79) | 3 (6) |
| Eye disorders | 7 (13) | 1 (2) | 0 (0) | 0 (0) |
| Eye hemorrhage | 3 (6) | 0 (0) | 0 (0) | 0 (0) |
| Retinal hemorrhage | 3 (6) | 1 (2) | 0 (0) | 0 (0) |
| Gastrointestinal disorders | 18 (35) | 0 (0) | 14 (27) | 1 (2) |
| Gingival bleeding | 9 (17) | 0 (0) | 6 (12) | 0 (0) |
| Rectal bleeding | 4 (8) | 0 (0) | 1 (2) | 0 (0) |
| Gastrointestinal hemorrhage | 3 (6) | 0 (0) | 5 (10) | 1 (2) |
| General disorders and administration site conditions | 11 (21) | 0 (0) | 3 (6) | 0 (0) |
| Injection site hemorrhage | 9 (17) | 0 (0) | 3 (6) | 0 (0) |
| Investigations | 9 (17) | 0 (0) | 7 (14) | 0 (0) |
| Hematuria | 7 (13) | 0 (0) | 6 (12) | 0 (0) |
| Respiratory, thoracic, and mediastinal disorders | 24 (46) | 1 (2) | 21 (41) | 0 (0) |
| Epistaxis | 22 (42) | 1 (2) | 21 (41) | 0 (0) |
| Hemoptysis | 6 (12) | 0 (0) | 2 (4) | 0 (0) |
| Skin and subcutaneous tissue disorders | 19 (37) | 0 (0) | 15 (29) | 0 (0) |
| Purpura | 8 (15) | 0 (0) | 7 (14) | 0 (0) |
| Petechiae | 7 (13) | 0 (0) | 8 (16) | 0 (0) |
| Ecchymosis | 3 (6) | 0 (0) | 0 (0) | 0 (0) |
| Surgical and medical procedure | 3 (6) | 0 (0) | 1 (2) | 0 (0) |
| Postoperative hemorrhage | 3 (6) | 0 (0) | 0 (0) | 0 (0) |
| Vascular disorders | 7 (13) | 0 (0) | 4 (8) | 0 (0) |
| Hematoma | 7 (13) | 0 (0) | 4 (8) | 0 (0) |
| System organ class . | Test (n = 52), no. (%) . | Reference (n = 51), no. (%) . | ||
|---|---|---|---|---|
| Total . | Severe . | Total . | Severe . | |
| Any hemorrhagic event | 41 (79) | 3 (6) | 38 (79) | 3 (6) |
| Eye disorders | 7 (13) | 1 (2) | 0 (0) | 0 (0) |
| Eye hemorrhage | 3 (6) | 0 (0) | 0 (0) | 0 (0) |
| Retinal hemorrhage | 3 (6) | 1 (2) | 0 (0) | 0 (0) |
| Gastrointestinal disorders | 18 (35) | 0 (0) | 14 (27) | 1 (2) |
| Gingival bleeding | 9 (17) | 0 (0) | 6 (12) | 0 (0) |
| Rectal bleeding | 4 (8) | 0 (0) | 1 (2) | 0 (0) |
| Gastrointestinal hemorrhage | 3 (6) | 0 (0) | 5 (10) | 1 (2) |
| General disorders and administration site conditions | 11 (21) | 0 (0) | 3 (6) | 0 (0) |
| Injection site hemorrhage | 9 (17) | 0 (0) | 3 (6) | 0 (0) |
| Investigations | 9 (17) | 0 (0) | 7 (14) | 0 (0) |
| Hematuria | 7 (13) | 0 (0) | 6 (12) | 0 (0) |
| Respiratory, thoracic, and mediastinal disorders | 24 (46) | 1 (2) | 21 (41) | 0 (0) |
| Epistaxis | 22 (42) | 1 (2) | 21 (41) | 0 (0) |
| Hemoptysis | 6 (12) | 0 (0) | 2 (4) | 0 (0) |
| Skin and subcutaneous tissue disorders | 19 (37) | 0 (0) | 15 (29) | 0 (0) |
| Purpura | 8 (15) | 0 (0) | 7 (14) | 0 (0) |
| Petechiae | 7 (13) | 0 (0) | 8 (16) | 0 (0) |
| Ecchymosis | 3 (6) | 0 (0) | 0 (0) | 0 (0) |
| Surgical and medical procedure | 3 (6) | 0 (0) | 1 (2) | 0 (0) |
| Postoperative hemorrhage | 3 (6) | 0 (0) | 0 (0) | 0 (0) |
| Vascular disorders | 7 (13) | 0 (0) | 4 (8) | 0 (0) |
| Hematoma | 7 (13) | 0 (0) | 4 (8) | 0 (0) |
The numbers of patients with hemorrhagic adverse events with a frequency of 5% or higher are listed for system organ class and for preferred terms within each system organ class. Within some system organ classes individual events (terms) occurred with a frequency of less than 5%; these were not listed but were captured within the system organ class. Some patients had more than one type of hemorrhagic event within a system organ class. The proportions (%) were compared by χ2 tests to determine whether statistical differences were present between the treatment groups. The proportion of severe hemorrhagic adverse events is indicated separately. Mild and moderate adverse events did not require specific treatment interventions. Severe adverse events required treatment intervention and change in patient activity status. There were no statistical differences (P > .05) between the treatment groups with respect to the incidence of any hemorrhagic adverse events.