Table 3.
Primary and Key Secondary End Points, According to Treatment Group.
| Characteristic | Platelet Dose* | |||||
|---|---|---|---|---|---|---|
| Low Dose (N = 417) |
P Value, Low vs. Medium Dose |
Medium Dose (N = 423) |
P Value, Medium vs. High Dose |
High Dose (N = 432) |
P Value, High vs. Low Dose |
|
| Primary end point | ||||||
| ≥1 Episode of bleeding of grade 2 or higher — % of patients |
71 | 0.60 | 69 | 0.71 | 70 | 0.94 |
| Secondary end points | ||||||
| Highest grade of bleeding during study — % of patients |
0.30 | 0.65 | 0.54 | |||
| No bleeding or grade 1 | 30 | 32 | 30 | |||
| Grade 2 | 58 | 59 | 60 | |||
| Grade 3 | 9 | 7 | 8 | |||
| Grade 4 | 3 | 2 | 2 | |||
| Death from hemorrhage — no. of patients | 0 | 0 | 1.00 | 1 | 1.00 | |
| No. of days with bleeding of grade 2 or higher |
0.90 | 0.91 | 0.99 | |||
| Median | 1 | 1 | 1 | |||
| Interquartile range | 0–4 | 0–4 | 0–4 | |||
| Days from randomization to onset of bleeding of grade 2 or higher |
0.85 | 0.66 | 0.55 | |||
| Median | 7 | 7 | 8 | |||
| Interquartile range | 3–18 | 3–19 | 3–19 | |||
| Red-cell transfusions | ||||||
| ≥1 Transfusion — % of patients | 95 | 0.12 | 92 | 1.00 | 92 | 0.09 |
| Total units per patient † | 0.62 | 0.70 | 0.90 | |||
| Median | 4 | 4 | 4 | |||
| Interquartile range | 2–8 | 2–8 | 2–8 | |||
| Platelet transfusions‡ | ||||||
| No. per patient | <0.001 | 0.09 | <0.001 | |||
| Median | 5 | 3 | 3 | |||
| Interquartile range | 3–9 | 2–6 | 2–6 | |||
| Total no. of platelets transfused, based on at-issue count — ×10−11 |
0.002 | <0.001 | <0.001 | |||
| Median | 9.25 | 11.25 | 19.63 | |||
| Interquartile range | 4.91–17.91 | 6.99–22.76 | 10.61–37.44 | |||
Platelet doses were as follows: low dose, 1.1×1011 platelets per square meter of body-surface area; medium dose, 2.2×1011 platelets per square meter; and high dose, 4.4×1011 platelets per square meter.
Analysis of the number of red-cell transfusions per patient was limited to data for patients who had at least one red-cell transfusion and who had no missing data on the number of units transfused: 394 patients in the low-dose group, 387 in the medium-dose group, and 397 in the high-dose group.
Analysis of the number of platelet transfusions per patient was limited to data for patients who had no missing data on the number of transfusion events and no missing data on the total number of platelets transfused: 295 patients in the low-dose group, 346 in the medium-dose group, and 359 in the high-dose group. In these patients, the tradeoffs between number of platelets and number of transfusion events can be assessed.