Incidence of TEAMV-PD, TEARDS, and platelet transfusion exposure
| mITT analysis . | |||
|---|---|---|---|
| TEAMV-PD, TEARDS, and PC exposure: all patients . | |||
| Parameter . | PRPC (n = 1068) . | CPC (n = 1223) . | PRPC vs CPC∗ . |
| Patients with TEAMV-PD†, n (%) | 18 (1.7) | 38 (3.1) | –1.5% (–2.7%, –0.2%) |
| TEARDS with TEAMV-PD‡, n (%) | 11 (1.0) | 22 (1.8) | .151 |
| PC transfused in patients with TEAMV-PD§, n ± SD) | 22.6 ± 22.1 | 13.6 ± 9.2 | .493 |
| Days of PC support in patients with TEAMV-PD‖, n ± SD | 14.8 ± 7.0 | 14.1 ± 7.2 | .632 |
| TEAMV-PD and TEARDS for patients receiving 1 PC transfusion | |||
| Parameter | PRPC (n = 295) | CPC (n = 406) | PRPC vs CPC |
| Patients with TEAMV-PD†, n (%) | 1 (0.3) | 2 (0.5) | 0.2% (–1.7%, 2.2%) |
| TEARDS with TEAMV-PD‡, n (%) | 1 (0.3) | 1 (0.2) | .793 |
| TEAMV, TEARDS, and PC exposure for patients receiving ≥2 PC transfusions | |||
| Parameter | PRPC (n = 773) | CPC (n = 816) | PRPC vs CPC∗ |
| Patients with TEAMV-PD†, n (%) | 17 (2.2) | 36 (4.4) | –2.4% (–4.2%, –0.6%) |
| TEARDS for TEAMV-PD‡, n (%) | 10 (1.3) | 21 (2.6) | .086 |
| PC transfused in patients with TEAMV-PD§, n ± SD | 23.8 ± 22.1 | 14.3 ± 9.0 | .414 |
| Days of PC support in patients with TEAMV-PD‖, n ± SD | 15.6 ± 6.3 | 14.8 ± 6.7 | .791 |
| mITT analysis . | |||
|---|---|---|---|
| TEAMV-PD, TEARDS, and PC exposure: all patients . | |||
| Parameter . | PRPC (n = 1068) . | CPC (n = 1223) . | PRPC vs CPC∗ . |
| Patients with TEAMV-PD†, n (%) | 18 (1.7) | 38 (3.1) | –1.5% (–2.7%, –0.2%) |
| TEARDS with TEAMV-PD‡, n (%) | 11 (1.0) | 22 (1.8) | .151 |
| PC transfused in patients with TEAMV-PD§, n ± SD) | 22.6 ± 22.1 | 13.6 ± 9.2 | .493 |
| Days of PC support in patients with TEAMV-PD‖, n ± SD | 14.8 ± 7.0 | 14.1 ± 7.2 | .632 |
| TEAMV-PD and TEARDS for patients receiving 1 PC transfusion | |||
| Parameter | PRPC (n = 295) | CPC (n = 406) | PRPC vs CPC |
| Patients with TEAMV-PD†, n (%) | 1 (0.3) | 2 (0.5) | 0.2% (–1.7%, 2.2%) |
| TEARDS with TEAMV-PD‡, n (%) | 1 (0.3) | 1 (0.2) | .793 |
| TEAMV, TEARDS, and PC exposure for patients receiving ≥2 PC transfusions | |||
| Parameter | PRPC (n = 773) | CPC (n = 816) | PRPC vs CPC∗ |
| Patients with TEAMV-PD†, n (%) | 17 (2.2) | 36 (4.4) | –2.4% (–4.2%, –0.6%) |
| TEARDS for TEAMV-PD‡, n (%) | 10 (1.3) | 21 (2.6) | .086 |
| PC transfused in patients with TEAMV-PD§, n ± SD | 23.8 ± 22.1 | 14.3 ± 9.0 | .414 |
| Days of PC support in patients with TEAMV-PD‖, n ± SD | 15.6 ± 6.3 | 14.8 ± 6.7 | .791 |
SD, standard deviation.
For noninferiority analysis, the treatment difference (T-C) and the 95% CI is presented. For continuous variables, P values (for treatment difference) are based on an analysis of variance model including treatment and 4-category primary disease therapy (chemotherapy, HSCT-myeloablative, HSCT- nonmyeloablative, and HSCT-RIC) as fixed effects. A point estimate and the corresponding 2-sided 95% CI for the treatment difference in LS means are also provided. For categorical variables, P values are based on a stratified CMH PRPC (general association), controlling for primary disease therapy. A P value <.05 is flagged with an “∗.”
Patients with TEAMV-PD evaluated by the blinded PEP based on review of clinical records, respiratory therapy, and all chest imaging studies in the medical record; based on review of 93 patients with protocol defined or deviant TEAMV.
TEARDS in patients with TEAMV to treat pulmonary injury assessed by the PEP was evaluated according to the Berlin criteria for ARDS.
Number of PCs transfused to patients during the active transfusion period of up to 21 days.
Days of platelet support period = (date of last study or nonstudy platelet transfusion, up to day 21 or platelet independence, whichever sooner) – (date of first study transfusion) + 1, in which platelet independence is defined as >5 days elapsed from the previous study or nonstudy platelet transfusion.