Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )

Here, the percentage of participants with all-cause mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.

Time frame: Up to 6 hours after randomization

Population: Analysis was performed on the ITT and modified ITT (mITT) population. The ITT population included all the randomized participants. The mITT population included all participants from ITT population who received at least one complete or partial dose of the investigational product (IP) (BE1116 or placebo). It also included participants with a missing or non-testable Glasgow Coma Score, or a score less than 15, as well as those who received blood product transfusions prior to randomization.

Renal replacement therapy included dialysis, hemofiltration, or hemodiafiltration. AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines is diagnosed if any one of the following happens: • Serum creatinine increases by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours • Serum creatinine increases to ≥ 1.5 times the baseline level, within the past 7 days • Urine levels drops to less than 0.5 mL/kg/hour for 6 hours

Time frame: Up to 30 days after randomization

Population: Analysis was performed on the safety population. The safety population included of all the participants from ITT population who received at least one complete or partial dose of BE1116 or placebo, based on the treatment actually received.

ARDS will be assessed using the Berlin definition based on four criteria: timing, chest imaging, origin of edema, oxygenation (mild, moderate or severe) and high-flow nasal oxygen.

Time frame: Up to 30 days after randomization

Population: Analysis was performed on the safety population. The safety population included of all the participants from ITT population who received at least one complete or partial dose of BE1116 or placebo, based on the treatment actually received.

The TEEs may be symptomatic or asymptomatic, and arterial or venous (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke \[including thromboembolic stroke\], myocardial infarction). The observed in-hospital overall and related to IP TEEs are reported here.

Time frame: Up to 30 days after randomization

Population: Analysis was performed on the safety population. The safety population included of all the participants from ITT population who received at least one complete or partial dose of BE1116 or placebo, based on the treatment actually received.

Multiple organ failure will be assessed using the Denver post injury multiple organ failure score. The Denver score rates the dysfunction of 4 organ systems (pulmonary, renal, hepatic, and cardiac), which are each graded on a scale from 0 to 3, where 0 represents mild and 3 was severe. Multiple organ failure is defined as a score \> 3.

Time frame: Up to 30 days after randomization

Population: Analysis was performed on the safety population. The safety population included of all the participants from ITT population who received at least one complete or partial dose of BE1116 or placebo, based on the treatment actually received.

The number of participants with treatment-emergent SAEs considered related to IP that occurred during primary hospitalization within the 30 days after randomization are summarized by treatment arm.

Time frame: Up to 30 days after randomization

Population: Analysis was performed on the safety population. The safety population included of all the participants from ITT population who received at least one complete or partial dose of BE1116 or placebo, based on the treatment actually received.

Here, the percentage of participants with who underwent surgical or interventional radiological procedures to stop bleeding related to the primary injury has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.

Time frame: Up to 24 hours after randomization

Population: As planned, analysis was performed on the mITT population. The mITT population included all participants from ITT population who received at least one complete or partial dose of BE1116 or placebo. It also included participants with a missing or non-testable Glasgow Coma Score, or a score less than 15, as well as those who received blood product transfusions prior to randomization.

In-hospital mortality up to 24 hours after randomization was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.

Time frame: Up to 24 hours after randomization

Population: As planned, analysis was performed on the mITT population. The mITT population included all participants from ITT population who received at least one complete or partial dose of BE1116 or placebo. It also included participants with a missing or non-testable Glasgow Coma Score, or a score less than 15, as well as those who received blood product transfusions prior to randomization.

In-hospital mortality was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.

Time frame: Up to 30 days after randomization

Population: As planned, analysis was performed on the mITT population. The mITT population included all participants from ITT population who received at least one complete or partial dose of BE1116 or placebo. It also included participants with a missing or non-testable Glasgow Coma Score, or a score less than 15, as well as those who received blood product transfusions prior to randomization.