TABLE 3.
Incidence of treatment‐emergent assisted mechanical ventilation and treatment‐emergent acute respiratory distress syndrome
| Modified intention‐to‐treat analysis | |||
|---|---|---|---|
| Parameter | PRPC n = 1068 | CPC n = 1223 | PRPC versus CPC a |
| Treatment‐emergent assisted mechanical ventilation and platelet component exposure | |||
| Patients with TEAMV: n (%) b | 31 (2.9) | 56 (4.6) | −1.7% (−3.3%, −0.1%) |
| Median days to TEAMV c | >30 | >30 | 0.076 |
| Patients with TEAMV‐PD: n (%) d | 18 (1.7) | 38 (3.1) | −1.5% (−2.7%, −0.2%) |
| LS mean days to TEAMV after PC for 56 patients with TEAMV‐PD e | 10.7 ± 1.2 | 6.0 ± 1.2 | 4.6 (0.3, 8.9) |
| Treatment‐emergent ARDS for TEAMV‐PD: n (%) f | 11 (1.0) | 22 (1.8) | 0.151 |
| PC exposure in patients with TEAMV‐PD (n ± SD) g | 22.6 ± 22.1 | 13.6 ± 9.2 | 0.493 |
| Days of PC support in patients with TEAMV‐PD (n ± SD) h | 14.8 ± 7.0 | 14.1 ± 7.2 | 0.632 |
| Per protocol analysis | |||
|---|---|---|---|
| Treatment‐emergent assisted mechanical ventilation and platelet component exposure | |||
| Parameter | PRPC n = 1002 | CPC n = 1036 | PRPC versus CPC a |
| Patients with TEAMV: n (%) b | 26 (2.6) | 39 (3.8) | −1.3% (−2.9%, 0.3%) |
| Median days to TEAMV c | >30 | >30 | 0.199 |
| Patients with TEAMV ‐PD: n (%) d | 14 (1.4) | 25 (2.4) | −1.2% (−2.5%, 0.0%) |
| LS Mean Days to TEAMV after PC for 39 Patients with TEAMV‐PD e | 9.1 | 6.8 | 2.2 (−1.7, 6.2) |
| Treatment‐emergent ARDS for TEAMV‐PD: n (%) f | 8 (0.8) | 16 (1.5) | 0.132 |
| PC exposure in patients with TEAMV‐PD (n ± SD) g | 26.1 ± 23.4 | 15.7 ± 9.8 | 0.278 |
| Days of PC support in patients with TEAMV‐PD (n ± SD) h | 15.9 ± 6.4 | 14.4 ± 7.4 | 0.977 |
For non‐inferiority analysis the treatment difference (T‐C) and the 95% confidence interval is presented. For continuous variables, p‐values (for treatment difference) are based on an ANOVA model including treatment and 4‐category primary disease therapy (chemotherapy, HCT‐myelo, HCT‐non‐myelo, and HCT‐RIC) as fixed effects. A point estimate and the corresponding two‐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 <.050 is flagged with an asterisk (*).
Time in days from first study PC transfusion to the initiation of TEAMV for pulmonary injury evaluated by the PEP. Least‐squares (LS) means were derived from a negative binomial model with transfusion history as a covariate.
Protocol defined treatment‐emergent assisted mechanical ventilation (TEAMV) is defined as any patient with ventilation by tight‐fitting mask or intubation with positive end expiratory pressure ≥5 cmH2O initiated after the first exposure to study PC.
Median days to protocol defined TEAMV by Kaplan Meier method.
Patients with TEAMV‐PD indicated for pulmonary disease 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.
Treatment‐emergent acute respiratory syndrome (TEARDS) in patients with TEAMV to treat pulmonary injury assessed by the PEAP was evaluated according to the Berlin Criteria for ARDS.
Number of platelet components (PCs) transfused to patients during the active transfusion period of up to 21 days.
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.