Table 3.
Post hoc analysis of inflammatory adverse events and American Trial to Evaluate Tranexamic Acid Therapy in Thrombocytopenia outcomes.
| Inflammatory adverse event | Allo |
Auto |
Chemo |
Total |
Total |
||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo |
TXA |
Placebo |
TXA |
Placebo |
TXA |
Placebo |
TXA |
||
| (n = 65), n (%) | (n = 63), n (%) | (n = 36), n (%) | (n = 34), n (%) | (n = 62), n (%) | (n = 66), n (%) | (n = 163), n (%) | (n = 163), n (%) | (N = 326), n (%) | |
| All rashes during study treatment | 28 (43.1) | 30 (47.6) | 5 (13.9) | 7 (20.6) | 16 (25.8) | 24 (36.4) | 49 (30.1) | 61 (37.4) | 110 (33.7) |
| Grade 3+ mucositis during study treatment | 24 (36.9) | 31 (49.2) | 6 (16.7) | 10 (29.4) | 2 (3.2) | 0 (0.0) | 32 (19.6) | 41 (25.2) | 73 (22.4) |
| Febrile neutropenia during study treatment | 33 (50.8) | 28 (44.4) | 18 (50.0) | 22 (64.7) | 43 (69.4) | 51 (77.3) | 94 (57.7) | 101 (62.0) | 195 (59.8) |
| Fever during study treatment | 11 (16.9) | 5 (7.9) | 2 (5.6) | 4 (11.8) | 4 (6.5) | 8 (12.1) | 17 (10.4) | 17 (10.4) | 34 (10.4) |
| Any infection during study treatment | 34 (52.3) | 29 (46.0) | 11 (30.6) | 10 (29.4) | 34 (54.8) | 30 (45.5) | 79 (48.5) | 69 (42.3) | 148 (45.4) |
| Grade 3+ infections during study treatment | 19 (29.2) | 12 (19.0) | 5 (13.9) | 1 (2.9) | 22 (35.5) | 16 (24.2) | 46 (28.2) | 29 (17.8) | 75 (23.0) |
| GVHD during study treatment | 4 (6.2) | 2 (3.2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 4 (2.5) | 2 (1.2) | 6 (1.8) |
| VOD/SOS | 2 (3.1) | 3 (4.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (1.2) | 3 (1.8) | 5 (1.5) |
| WHO grade 2+ bleeding | 38 (58.5) | 36 (57.1) | 8 (22.2) | 5 (14.7) | 31 (50.0) | 31 (47.0) | 77 (47.2) | 72 (44.2) | 149 (45.7) |
| Platelet transfusions | 7.1 (6.2) | 7.9 (8.3) | 2.8 (2.0) | 3.6 (3.6) | 8.3 (6.5) | 7.9 (5.6) | 6.6 (6.1) | 7.0 (6.7) | 6.7 (6.3) |
| RBC transfusions | 6.0 (4.1) | 6.3 (4.6) | 1.9 (2.2) | 2.1 (2.0) | 7.8 (4.1) | 7.1 (3.9) | 5.8 (4.4) | 5.7 (4.3) | 5.7 (4.4) |
Outcomes by therapeutic group (allogeneic stem cell transplant [allo], autologous stem cell transplant [auto], and chemotherapy [chemo] only) and the total study population. The Common Toxicology Criteria for Adverse Events version 4.03 grading system was used for all outcomes except bleeding, which used the WHO grading scale.
GVHD, graft vs host disease; RBC, red blood cell; SOS, sinusoidal obstruction syndrome; TXA, tranexamic acid; VOD, veno-occlusive disease; WHO, World Health Organization.