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Northfield Laboratories Reports Results of Pivotal Phase III Trauma,Study

the control group at 51% (p(less than or =)0.05). There was no statistically significant difference between PolyHeme and control patients for the other efficacy endpoints. -0-



                               TABLE 2

                           DAY 1 MORTALITY



                                        PolyHeme        Control

                                       (deaths/N)  %   (deaths/N)  %

 ------------------------------------- ---------- ---- ---------- ----

 MITT                                   34/350    9.7   27/364    7.4

 ------------------------------------- ---------- ---- ---------- ----

 AT                                     33/349    9.5   28/365    7.7

 ------------------------------------- ---------- ---- ---------- ----

 PP                                     20/279    7.2   21/307    6.8

 ------------------------------------- ---------- ---- ---------- ----

Safety Analysis

The primary safety endpoints in the study were Day 1 mortality, Day 30 mortality, and durable serious adverse events (SAEs). Durable serious adverse events were prospectively defined as SAEs which resulted in a "permanently disabling" outcome. There were two durable SAEs in each group. There was no statistically significant difference between the PolyHeme and control groups for any of these endpoints.

Additional Safety Data

All adverse events (AEs), serious adverse events (SAEs), cardiac SAEs, and myocardial infarction (MI) were also analyzed. The overall incidence of AEs in the PolyHeme group of 93% (324 patients) was higher than that in the control group of 88% (322 patients), (p(less than or =)0.05). The most common AEs in both groups were: anemia, fever, and electrolyte imbalances. The overall incidence of SAEs in the study was 40% (141 patients) in the PolyHeme group and 35% (126 patients) in the control group (pgreater than or 0.05). The most common SAEs in both groups were: shock, pneumonia, and respiratory failure.


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