TABLE 2.
Exposure to study platelet and red blood cell (RBC) components by mITT and per protocol analysis by primary disease therapy strata
| Modified intention‐to‐treat analysis | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Parameter | Chemotherapy | HCT myeloablative | HCT non‐ablative + RIC | Total | PRPC‐CPC a | ||||
| PRPC | CPC | PRPC | CPC | PRPC | CPC | PRPC | CPC | ||
| Patients (n) | 524 | 717 | 405 | 374 | 139 | 132 | 1068 | 1223 | |
| PC transfused | |||||||||
| Mean | 4.3 ± 4.2 | 4.5 ± 5.0 | 4.6 ± 6.1 | 3.6 ± 4.3 | 8.4 ± 9.8 | 6.8 ± 7.1 | 4.9 ± 6.1 | 4.5 ± 5.1 | 0.046* |
| Median | 3 | 2 | 3 | 2 | 5 | 4 | 3 | 2 | |
| Days of PC support b | |||||||||
| Mean | 6.9 ± 6.7 | 7.2 ± 7.1 | 4.7 ± 4.8 | 5.0 ± 5.3 | 9.2 ± 7.2 | 9.2 ± 7.8 | 6.4 ± 6.3 | 6.7 ± 6.8 | 0.447 |
| Median | 5 | 4 | 3 | 3 | 7 | 7 | 4 | 4 | |
| RBC components transfused | |||||||||
| Patients: n (%) | 357 (68) | 454 (63) | 188 (46) | 184 (49) | 94 (68) | 78 (59) | 639 (60) | 716 (59) | |
| Mean | 3.1 ± 2.8 | 3.5 ± 3.3 | 2.5 ± 2.2 | 2.4 ± 2.1 | 3.9 ± 3.0 | 4.0 ± 3.2 | 3.0 ± 2.7 | 3.3 ± 3.1 | 0.146 |
| Median | 2 | 2 | 2 | 2 | 3 | 3 | 2 | 2 | |
| Per protocol analysis | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Parameter | Chemotherapy | HCT myeloablative | HCT non‐ablative + RIC | Total | PRPC‐CPC | ||||
| PRPC | CPC | PRPC | CPC | PRPC | CPC | PRPC | CPC | ||
| Patients: n (%) | 490 | 545 | 385 | 362 | 127 | 129 | 1002 | 1036 | |
| PC transfused | |||||||||
| Mean | 4.3 ± 4.2 | 4.6 ± 5.1 | 4.4 ± 5.9 | 3.6 ± 4.3 | 8.1 ± 10.0 | 6.9 ± 7.1 | 4.8 ± 6.0 | 4.5 ± 5.2 | 0.153 |
| Median | 3 | 2 | 2 | 2 | 5 | 4 | 3 | 2 | |
| Days of PC support | |||||||||
| Mean | 6.7 ± 6.7 | 7.2 ± 7.1 | 4.5 ± 4.5 | 4.8 ± 5.1 | 8.7 ± 7.0 | 9.3 ± 7.7 | 6.1 ± 6.2 | 6.6 ± 6.7 | 0.148 |
| Median | 4 | 4 | 3 | 3 | 7 | 7 | 4 | 4 | |
| RBC components transfused | |||||||||
| Patients: n (%) | 331 (68) | 346 (63) | 176 (46) | 174 (48) | 83 (65) | 77 (60) | 590 (59) | 597 (58) | |
| Mean | 3.0 ± 2.8 | 3.6 ± 3.5 | 2.4 ± 2.1 | 2.4 ± 2.1 | 3.6 ± 2.5 | 4.0 ± 3.2 | 2.9 ± 2.6 | 3.3 ± 3.2 | 0.016* |
| Median | 2 | 2 | 2 | 2 | 3 | 3 | 2 | 2 | |
For continuous variables, p‐values (for treatment difference) are based on an ANOVA model including treatment and 4‐category primary disease therapy (chemotherapy, HCT‐myeloablative, HCT‐non‐myeloablative, and HCT‐RIC) as fixed effects. A point estimate and the corresponding two‐sided 95% CI for the treatment difference in least squares means are also provided. For categorical variables, the p‐values are based on a stratified CMH General Association PRPC controlling for primary disease therapy. A p‐value <.050 is flagged with an asterisk (*).
Days of platelet support period = (date of last study or non‐study platelet transfusion, up to Day 21 or platelet independence, whichever occurred sooner)−(date of first study transfusion) + 1, where platelet independence is defined as more than 5 days elapsed from the previous study or non‐study platelet transfusion.