Incidence of CSPAE and PC exposure
| mITT analysis . | |||
|---|---|---|---|
| CSPAE and PC exposure: all patients . | |||
| Parameter . | PRPC, n = 1068 . | CPC, n = 1223 . | PRPC vs CPC∗ . |
| Patients with CSPAE†, n (%) | 151(14.1) | 180 (14.7) | .810 |
| Patients with serious CSPAE‡, n (%) | 67(6.3) | 85(7.0) | .705 |
| PC transfused in patients with CSPAE§, n ± SD | 9.8 ± 10.0 | 9.9 ± 7.9 | .746 |
| Days of PC support in patients with CSPAE‖, n ± SD | 11.0 ± 7.3 | 12.8 ± 7.5 | .029∗ |
| CSPAE for patients with 1 PC transfusion | |||
| Parameter | PRPC n = 295 | CPC n = 406 | PRPC vs CPC∗ |
| Patients with CSPAE†, n (%) | 9 (3.1) | 14 (3.4) | .811 |
| Patients with serious CSPAE‡, n (%) | 6 (2.0) | 7 (1.7) | .715 |
| CSPAE for patients with ≥ 2 PC transfusions | |||
| Parameter | PRPC n = 773 | CPC n = 816 | PRPC vs CPC∗ |
| Patients with CSPAE†, n (%) | 142 (18.4) | 166 (20.3) | .455 |
| Patients with serious CSPAE‡, n (%) | 61 (7.9) | 78 (9.6) | .410 |
| PC transfused in patients with CSPAE§, n ± SD | 10.4 ± 10.1 | 10.6 ± 7.8 | .677 |
| Days of PC support in patients with CSPAE‖, n ± SD | 11.6 ± 7.0 | 13.7 ± 6.9 | .011∗ |
| mITT analysis . | |||
|---|---|---|---|
| CSPAE and PC exposure: all patients . | |||
| Parameter . | PRPC, n = 1068 . | CPC, n = 1223 . | PRPC vs CPC∗ . |
| Patients with CSPAE†, n (%) | 151(14.1) | 180 (14.7) | .810 |
| Patients with serious CSPAE‡, n (%) | 67(6.3) | 85(7.0) | .705 |
| PC transfused in patients with CSPAE§, n ± SD | 9.8 ± 10.0 | 9.9 ± 7.9 | .746 |
| Days of PC support in patients with CSPAE‖, n ± SD | 11.0 ± 7.3 | 12.8 ± 7.5 | .029∗ |
| CSPAE for patients with 1 PC transfusion | |||
| Parameter | PRPC n = 295 | CPC n = 406 | PRPC vs CPC∗ |
| Patients with CSPAE†, n (%) | 9 (3.1) | 14 (3.4) | .811 |
| Patients with serious CSPAE‡, n (%) | 6 (2.0) | 7 (1.7) | .715 |
| CSPAE for patients with ≥ 2 PC transfusions | |||
| Parameter | PRPC n = 773 | CPC n = 816 | PRPC vs CPC∗ |
| Patients with CSPAE†, n (%) | 142 (18.4) | 166 (20.3) | .455 |
| Patients with serious CSPAE‡, n (%) | 61 (7.9) | 78 (9.6) | .410 |
| PC transfused in patients with CSPAE§, n ± SD | 10.4 ± 10.1 | 10.6 ± 7.8 | .677 |
| Days of PC support in patients with CSPAE‖, n ± SD | 11.6 ± 7.0 | 13.7 ± 6.9 | .011∗ |
SD, standard deviation.
P values are based on a stratified CMH PRPC (general association), controlling for 4-category primary disease therapy (chemotherapy, HSCT-myeloablative, HSCT-nonmyeloablative, and HSCT-RIC). A P value <.05 is flagged with an “∗.”
Clinically significant pulmonary adverse events (CSPAE) are AEs with CTCAE grade ≥2. CSPAEs are treatment-emergent AEs, defined as AEs with an onset on or after the start of the first study platelet transfusion. By default, AEs with missing onset date are treatment emergent. AEs with missing relationship/severity/seriousness are categorized as related/severe/serious AEs. MedDRA version 18.0 is used.
Serious CSPAE are those events that meet the criteria for serious (death, life-threatening event, inpatient hospitalization, persistent or significant disability/incapacitation, congenital anomaly/birth defect, or another significant medical event).
The number of PCs transfused during the active transfusion period of up to 21 days after enrollment.
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.