Safety endpoints
| . | . | TXA . | Placebo . |
|---|---|---|---|
| N | 163 | 163 | |
| Line occlusions, n (%) | 27 (16.6) | 11 (6.7) | |
| Thrombotic events, n (%) | 6 (3.7) | 9 (5.5) | |
| Serious adverse events,*n (%) | |||
| Any | 123/163 (75.5) | 110/163 (67.5) | |
| System organ class | Preferred term | ||
| Blood | Febrile neutropenia | 40/163 (24.5) | 36/163 (22.1) |
| Cardiac | Overall | 19/163 (11.7) | 20/163 (12.3) |
| General | Overall | 40/163 (24.5) | 50/163 (30.7) |
| Fatigue | 17/163 (10.4) | 15/163 (9.2) | |
| Fever | 12/163 (7.4) | 12/163 (7.4) | |
| Limb edema | 7/163 (4.3) | 13/163 (8.0) | |
| GI | Overall | 56/163 (34.4) | 49/163 (30.1) |
| Infections | Overall | 36/163 (22.1) | 43/163 (26.4) |
| Respiratory | Overall | 33/163 (20.2) | 39/163 (23.9) |
| Skin | Overall | 21/163 (12.9) | 25/163 (15.3) |
| Vascular | Overall | 19/163 (11.7) | 20/163 (12.3) |
| Adverse events* | |||
| Any | 162/163 (99.4) | 161/163 (98.8) | |
| Blood | Febrile neutropenia | 110/163 (67.5) | 105/163 (64.4) |
| Cardiac | Overall | 94/163 (57.7) | 86/163 (52.8) |
| General | Overall | 145/163 (89.0) | 144/163 (88.3) |
| Fatigue | 105/163 (64.4) | 109/163 (66.9) | |
| Limb edema | 68/163 (41.7) | 70/163 (42.9) | |
| GI | Overall | 155/163 (95.1) | 154/163 (94.5) |
| Infections | Overall | 98/163 (60.1) | 99/163 (60.7) |
| Respiratory | Overall | 125/163 (76.7) | 130/163 (79.8) |
| Skin | Overall | 115/163 (70.6) | 116/163 (71.2) |
| Vascular | Overall | 96/163 (58.9) | 103/163 (63.2) |
| . | . | TXA . | Placebo . |
|---|---|---|---|
| N | 163 | 163 | |
| Line occlusions, n (%) | 27 (16.6) | 11 (6.7) | |
| Thrombotic events, n (%) | 6 (3.7) | 9 (5.5) | |
| Serious adverse events,*n (%) | |||
| Any | 123/163 (75.5) | 110/163 (67.5) | |
| System organ class | Preferred term | ||
| Blood | Febrile neutropenia | 40/163 (24.5) | 36/163 (22.1) |
| Cardiac | Overall | 19/163 (11.7) | 20/163 (12.3) |
| General | Overall | 40/163 (24.5) | 50/163 (30.7) |
| Fatigue | 17/163 (10.4) | 15/163 (9.2) | |
| Fever | 12/163 (7.4) | 12/163 (7.4) | |
| Limb edema | 7/163 (4.3) | 13/163 (8.0) | |
| GI | Overall | 56/163 (34.4) | 49/163 (30.1) |
| Infections | Overall | 36/163 (22.1) | 43/163 (26.4) |
| Respiratory | Overall | 33/163 (20.2) | 39/163 (23.9) |
| Skin | Overall | 21/163 (12.9) | 25/163 (15.3) |
| Vascular | Overall | 19/163 (11.7) | 20/163 (12.3) |
| Adverse events* | |||
| Any | 162/163 (99.4) | 161/163 (98.8) | |
| Blood | Febrile neutropenia | 110/163 (67.5) | 105/163 (64.4) |
| Cardiac | Overall | 94/163 (57.7) | 86/163 (52.8) |
| General | Overall | 145/163 (89.0) | 144/163 (88.3) |
| Fatigue | 105/163 (64.4) | 109/163 (66.9) | |
| Limb edema | 68/163 (41.7) | 70/163 (42.9) | |
| GI | Overall | 155/163 (95.1) | 154/163 (94.5) |
| Infections | Overall | 98/163 (60.1) | 99/163 (60.7) |
| Respiratory | Overall | 125/163 (76.7) | 130/163 (79.8) |
| Skin | Overall | 115/163 (70.6) | 116/163 (71.2) |
| Vascular | Overall | 96/163 (58.9) | 103/163 (63.2) |
GI, gastrointestinal.
A more detailed list of serious adverse events and adverse events is provided in supplemental File 2, Appendix H.