Proportion of patients with grade 2 or higher bleeding
. | PCT, n (%) n = 318 . | Control, n (%) n = 327 . | P* . |
|---|---|---|---|
| Any grade 2 bleeding | 186 (58.5) | 188 (57.5) | <.01† |
| Grade 2 bleeding by bleeding site | |||
| Genitourinary | 104 (32.7) | 103 (31.5) | 0.80 |
| Mucocutaneous | 82 (25.8) | 65 (19.9) | 0.08 |
| Invasive sites | 69 (21.7) | 65 (19.9) | 0.63 |
| Gastrointestinal | 60 (18.9) | 63 (19.3) | 0.92 |
| Respiratory | 35 (11.0) | 28 (8.6) | 0.35 |
| Musculoskeletal | 15 (4.7) | 18 (5.5) | 0.72 |
| Body cavity | 0 (0.0) | 1 (0.3) | 1.00 |
| Neurologic | 0 (0.0) | 0 (0.0) | — |
| Any grade 3 or 4 bleeding | 13 (4.1) | 20 (6.1) | <.01‡ |
. | PCT, n (%) n = 318 . | Control, n (%) n = 327 . | P* . |
|---|---|---|---|
| Any grade 2 bleeding | 186 (58.5) | 188 (57.5) | <.01† |
| Grade 2 bleeding by bleeding site | |||
| Genitourinary | 104 (32.7) | 103 (31.5) | 0.80 |
| Mucocutaneous | 82 (25.8) | 65 (19.9) | 0.08 |
| Invasive sites | 69 (21.7) | 65 (19.9) | 0.63 |
| Gastrointestinal | 60 (18.9) | 63 (19.3) | 0.92 |
| Respiratory | 35 (11.0) | 28 (8.6) | 0.35 |
| Musculoskeletal | 15 (4.7) | 18 (5.5) | 0.72 |
| Body cavity | 0 (0.0) | 1 (0.3) | 1.00 |
| Neurologic | 0 (0.0) | 0 (0.0) | — |
| Any grade 3 or 4 bleeding | 13 (4.1) | 20 (6.1) | <.01‡ |
— indicates not applicable.
Fisher exact test was used to calculate the P value for each of the 8 potential bleeding sites
The P value for the overall proportion of patients with grade 2 bleeding was < .01, based on a noninferiority test with a noninferiority margin of 0.125 (one-sided 95% confidence interval of difference: —1, 0.07). By using this method, a P value of < .05 indicates that PCT was not inferior to control
The P value for any grade 3 or 4 bleeding was < .01, based on a noninferiority test with a noninferiority margin of .07 (one-sided 95% confidence interval of difference: —1, 0.013). By using this method, a P value of < .05 indicates that PCT was not inferior to control