Table 2.
Association of grade 3+ infections while on study drug and bleeding outcomes.
| Clinical outcomes | No grade 3+ infection |
Grade 3+ infection |
||||
|---|---|---|---|---|---|---|
| Placebo |
TXA |
Total |
Placebo |
TXA |
Total |
|
| (n = 117) | (n = 134) | (N = 251) | (n = 46) | (n = 29) | (N = 75) | |
| Highest grade bleed, mean [19] | 1.3 (0.7) | 1.4 (0.7) | 1.3 (0.7) | 1.8 (0.9) | 1.8 (0.9) | 1.8 (0.9) |
| Any grade 2+ bleed, n (%) | 47 (40.2) | 53 (39.6) | 100 (39.8) | 30 (65.2) | 19 (65.5) | 49 (65.3) |
| Grade 2+ bleeding before infection, n (%) | -- | -- | -- | 29 (63.0) | 19 (65.5) | 48 (64.0) |
| RBC transfusions, mean [19] | 4.7 (3.9) | 5.1 (3.9) | 4.9 (3.9) | 8.5 (4.4) | 8.9 (4.8) | 8.6 (4.5) |
| Platelet transfusions, mean [19] | 5.0 (4.7) | 6.0 (6.0) | 5.6 (5.5) | 10.7 (7.2) | 11.3 (7.7) | 10.9 (7.4) |
| Time on study drug, mean [19] | 13.5 (7.6) | 14.8 (8.0) | 14.2 (7.8) | 20.1 (8.6) | 18.4 (8.0) | 19.4 (8.4) |
| Time to platelet recovery, mean [19] | 13.8 (6.6) | 16.8 (8.3) | 15.4 (7.7) | 22.0 (10.3) | 21.0 (7.6) | 21.6 (9.4) |
| Duration of severe neutropenia | 14.1 (8.4) | 15.8 (8.5) | 15.0 (8.5) | 19.3 (7.9) | 19.9 (7.5) | 19.5 (7.7) |
The Common Toxicology Criteria for Adverse Events version 4.03 grading system was used to grade infections; the World Health Organization bleeding scale was used to grade bleeds. Severe neutropenia was defined as <500/μL; duration truncated at 30 days.
RBC, red blood cell; TXA, tranexamic acid.