A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components

The study will have a pilot run-in period and two sequential cohort groups for each center.

Pilot Run-in Period The pilot run-in period will be conducted in each center with a group of
at least 5 patients exposed only to conventional PCs, who provide informed consent for data
collection. The purpose of this pilot run-in is to evaluate study logistics and data
collection methods within each study center. Data collection will not differ from that
required in the two sequential patient cohorts. The data from the pilot phase will be
included in the data listings but not included for the treatment comparisons.

Control and INTERCEPT Cohorts Following the run-in period, the study will be conducted in two
sequential cohort periods. Informed consent for data collection without study specific
treatment intervention, and under patient confidentiality, will be required for both cohorts
prior to any study procedure.

During the Control cohort period, patients will have study data collected following
transfusion with only conventional PCs for up to 21 days of transfusion support, as
clinically indicated in a manner that is consistent with the local standard of care. During
the INTERCEPT phase, patients will receive only INTERCEPT PCs under the same clinical
treatment guideline. Patients will be transfused with only study PCs of the assigned
treatment type (Conventional or INTERCEPT) in each cohort. Enrollment will be stratified by
study center and type of primary disease therapy (autologous HSCT, allogeneic HSCT, cord
blood HSCT, and chemotherapy).

For both cohorts, patients will be supported with study PC transfusions for a maximum of 21
days or until platelet transfusion independence. Patients are considered to have achieved
platelet transfusion independence if more than 5 days elapse after exposure to a study PC
transfusion. When a patient achieves platelet independence, the patient will have completed
the study PC transfusion period (even if they subsequently resume another cycle of platelet
support).

Data collection for all participants will comprise: patient baseline disease characteristics,
including primary disease, type of HSCT (auto, allo, cord blood, matched related or matched
unrelated) or type of chemotherapy, and medications at study entry and during the study
observation period. Patient clinical respiratory status, including a chest imaging study at
baseline prior to the first study transfusion in each cohort period, will be also be
recorded.

Within each study cohort, patients will be assessed for the primary outcome measure of
assisted ventilation for a maximum of 28 days (7 days surveillance following up to of 21 days
of study PC transfusion support). Furthermore, AEs (including TRs) will be collected from the
primary medical record for 24 hours following the initiation of each study PC transfusion.;
SAEs (including ARDS), Grade 2 or higher AEs affecting the Respiratory System, and mortality
will be collected for 7 days post each study transfusion (or until hospital
discharge/discontinuation of outpatient platelet transfusion support, whichever is sooner).
Investigators will assess the intensity of each AE and SAE and provide their assessment of
the relationship of each AE and SAE to the study transfusion. Patients who experience the
outcome of assisted ventilation, ARDS, or Grade 2 or higher AEs affecting the Respiratory
System will be assessed as detailed in Assessment of Pulmonary Adverse Events in the synopsis
and in Protocol Section 8.1.

For patients who achieve platelet independence before Study Day 21, AEs will be collected for
24 hours after initiating the last study platelet transfusion prior to platelet independence;
the outcome of assisted ventilation, SAEs, ARDS, Grade 2 or higher AEs affecting the
Respiratory System, and mortality will be collected for 7 days after the last study PC
transfusion prior to platelet independence (or until hospital discharge/discontinuation of
outpatient platelet transfusion support, whichever is sooner).

For patients who require more than 21 days of PC transfusion support, AEs will be recorded
for up to 24 hours after the initiation of the last platelet transfusion up to and including
Day 21; the outcome of assisted ventilation, SAEs, ARDS, Grade 2 or higher AEs affecting the
Respiratory System, and mortality will be collected for up to a maximum of 28 days (7 days
after up to 21 days of platelet transfusion support),7 days after initiating the last study
transfusion within the 21-day study transfusion period (or until hospital
discharge/discontinuation of outpatient platelet transfusion support, whichever is sooner).

Study-specific research personnel will review the patient medical record and record study
outcomes on electronic Case Report Forms (eCRF). The intensity of AEs and SAEs will be graded
according to the most recent version of the Common Terminology Criteria for Adverse Events
(CTCAE) classification system. The AEs and SAEs will be coded using MedDRA (Version 18.0 or
higher). TRs will also be assessed following the CDC National Healthcare Safety Network
(NHSN) Biovigilance Component Hemovigilance Module Surveillance Protocol (NHSN Protocol).

Inclusion Criteria:

- Patients with a hematology-oncology disorder expected to require or requiring a
transfusion of one or more PCs.

- Written signed informed consent (unless exemption of individual consent is granted by
the center's IRB).

Exclusion Criteria:

- Assisted ventilation (administered by intubation or tight fitting mask with PEEP or
CPAP ≥ 5 cm H2O) prior to the first study PC transfusion of a cohort period.

- Documented allergy to psoralens