TABLE 4.
Respiratory therapy, incidence of clinically significant pulmonary adverse events and platelet component exposure
| Modified intention‐to‐treat analysis | |||
|---|---|---|---|
| Respiratory therapy | |||
| Parameter | PRPC n = 1068 | CPC n = 1223 | PRPC versus CPC a |
| Patients with treatment‐emergent respiratory therapy of any type: n (%) | 189 (17.7) | 260 (21.3) | 0.064 |
| Intubation | 13 (1.2) | 40 (3.3) | |
| Tight‐fitting mask | 25 (2.3) | 30 (2.5) | |
| Loose‐fitting mask | 29 (2.7) | 47 (3.8) | |
| Nasal oxygen | 179 (16.8) | 240 (19.6) | |
| High‐flow oxygen or EzPAP | 14 (1.3) | 32 (2.6) | |
| No respiratory therapy required | 879 (82.3) | 963 (78.7) | |
| Clinically significant pulmonary adverse events | |||
| Patients with clinically significant pulmonary adverse events (CSPAE): n (%) b | 151 (14.1) | 180 (14.7) | 0.810 |
| Patients with Serious CSPAE: n (%) c | 67 (6.3) | 85 (7.0) | 0.705 |
| PC exposure in patients with CSPAE (n ± SD) d | 9.8 ± 10.0 | 9.9 ± 7.9 | 0.746 |
| Days of PC support in patients with CSPAE (n ± SD) e | 11.0 ± 7.3 | 12.8 ± 7.5 | 0.029* |
| per protocol analysis | |||
|---|---|---|---|
| Respiratory therapy | |||
| Parameter | PRPC n = 1002 | CPC n = 1036 | PRPC versus CPC a |
| Patients with treatment‐emergent respiratory therapy of any type: n (%) | 166 (16.6) | 218 (21.0) | 0.016* |
| Intubation | 11(1.1) | 30 (2.9) | |
| Tight‐fitting mask | 21 (2.1) | 20 (1.9) | |
| Loose‐fitting mask | 28 (2.8) | 42 (4.1) | |
| Nasal oxygen | 156 (15.6) | 202 (19.5) | |
| High‐flow oxygen or EzPAP | 12 (1.2) | 21(2.0) | |
| No respiratory therapy required | 836 (83.4) | 818 (79.0) | |
| Clinically significant pulmonary adverse events | |||
| Patients with CSPAEs: n (%) b | 135 (13.5) | 146 (14.1) | 0.795 |
| Patients with serious CSPAE: n (%) c | 59 (5.9) | 64 (6.2) | 0.889 |
| PC exposure in patients with CSPAE (n ± SD) d | 9.7 ± 10.3 | 10.2 ± 8.2 | 0.649 |
| Days of PC support in patients with CSPAE (n ± SD) e | 10.6 ± 7.2 | 12.8 ± 7.5 | 0.015* |
p‐values are based on a stratified CMH PRPC (General Association), controlling for four‐category primary disease therapy (Chemotherapy, HCT‐Myelo, HCT‐Non‐Myelo, and HCT‐RIC). A p‐value <.050 is flagged with an asterisk (*).
Clinically significant pulmonary adverse events (CSPAEs) are adverse events ≥ 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 PC transfused during the active transfusion period of up to 21 days after enrollment.
Days of platelet support period = (date of last study or non‐study platelet transfusion, up to Day 21 or platelet independence, whichever 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.