Trial Outcomes & Findings for Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ) (NCT NCT05568888)

NCT ID: NCT05568888

Last Updated: 2025-11-10

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1366 participants
• Primary outcome timeframe: Up to 6 hours after randomization
• Results posted on: 2025-11-10

Participant Flow

This study was conducted from 28 Mar 2023 to 29 October 2024 .

A total of 1366 participants were enrolled in this study. Of these, 1245 participants were treated as per their assigned treatment, either BE1116 or placebo.

Participant milestones

Measure	BE1116 Participants received a single administration of BE1116 via intravenous (IV) administration on Day 1.	Placebo Participants received IV administration of placebo matched to BE1116.
Overall Study STARTED	689	677
Overall Study Treated	618	627
Overall Study COMPLETED	628	605
Overall Study NOT COMPLETED	61	72

Reasons for withdrawal

Measure	BE1116 Participants received a single administration of BE1116 via intravenous (IV) administration on Day 1.	Placebo Participants received IV administration of placebo matched to BE1116.
Overall Study Physician Decision	1	0
Overall Study Protocol Deviation	2	1
Overall Study Withdrawal by Subject/Legally Authorized Representative	47	53
Overall Study Withdrawal by Parent/Guardian	10	14
Overall Study No IP Administered/Subject Excluded	1	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	BE1116 n=689 Participants Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=677 Participants Participants received IV administration of placebo matched to BE1116.	Total n=1366 Participants Total of all reporting groups
Age, Continuous	40.7 years STANDARD_DEVIATION 17.00 • n=5 Participants	39.8 years STANDARD_DEVIATION 17.65 • n=20 Participants	40.2 years STANDARD_DEVIATION 17.33 • n=40 Participants
Sex: Female, Male Female	163 Participants n=5 Participants	141 Participants n=20 Participants	304 Participants n=40 Participants
Sex: Female, Male Male	526 Participants n=5 Participants	536 Participants n=20 Participants	1062 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	97 Participants n=5 Participants	87 Participants n=20 Participants	184 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	490 Participants n=5 Participants	493 Participants n=20 Participants	983 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	102 Participants n=5 Participants	97 Participants n=20 Participants	199 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=5 Participants	12 Participants n=20 Participants	21 Participants n=40 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	21 Participants n=20 Participants	34 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=20 Participants	4 Participants n=40 Participants
Race (NIH/OMB) Black or African American	201 Participants n=5 Participants	210 Participants n=20 Participants	411 Participants n=40 Participants
Race (NIH/OMB) White	350 Participants n=5 Participants	335 Participants n=20 Participants	685 Participants n=40 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	5 Participants n=20 Participants	10 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	108 Participants n=5 Participants	93 Participants n=20 Participants	201 Participants n=40 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BE1116 n=689 Participants Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=677 Participants Participants received IV administration of placebo matched to BE1116.
Proportion of Participants With All-cause 6-hour Mortality All-cause Mortality in ITT Analysis Set	7.3 Percentage of participants	4.6 Percentage of participants
Proportion of Participants With All-cause 6-hour Mortality All-cause Mortality in mITT Analysis Set	7.2 Percentage of participants	4.1 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BE1116 n=432 Participants Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=436 Participants Participants received IV administration of placebo matched to BE1116.
Proportion of Participants With All-cause 24-hour In-hospital Mortality	11.1 Percentage of participants	7.3 Percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BE1116 n=432 Participants Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=436 Participants Participants received IV administration of placebo matched to BE1116.
Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization	24.8 Percentage of participants	18.6 Percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	BE1116 n=432 Participants Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=436 Participants Participants received IV administration of placebo matched to BE1116.
Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury	78.0 Percentage of participants	75.5 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BE1116 n=618 Participants Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=627 Participants Participants received IV administration of placebo matched to BE1116.
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)	34 Count of participants	46 Count of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BE1116 n=618 Participants Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=627 Participants Participants received IV administration of placebo matched to BE1116.
Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs) Overall TEEs	133 Count of participants	139 Count of participants
Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs) Related TEEs	46 Count of participants	51 Count of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BE1116 n=618 Participants Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=627 Participants Participants received IV administration of placebo matched to BE1116.
Number of Participants With Acute Respiratory Distress Syndrome (ARDS)	31 Count of participants	28 Count of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BE1116 n=618 Participants Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=627 Participants Participants received IV administration of placebo matched to BE1116.
Number of Participants With Multiple Organ Failure	59 Count of participants	53 Count of participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	BE1116 n=618 Participants Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=627 Participants Participants received IV administration of placebo matched to BE1116.
Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy	52 Count of participants	29 Count of participants

Adverse Events

BE1116

Serious events: 203 serious events

Other events: 32 other events

Deaths: 146 deaths

Placebo

Serious events: 168 serious events

Other events: 39 other events

Deaths: 114 deaths

Serious adverse events

Measure	BE1116 n=618 participants at risk Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=627 participants at risk Participants received IV administration of placebo matched to BE1116.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	6.8% 42/618 • Number of events 44 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	7.7% 48/627 • Number of events 50 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	2.9% 18/618 • Number of events 18 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	3.3% 21/627 • Number of events 21 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 10/618 • Number of events 10 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.80% 5/627 • Number of events 5 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Aortic aneurysm	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Acute Respiratory failure	1.1% 7/618 • Number of events 7 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.64% 4/627 • Number of events 4 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.97% 6/618 • Number of events 6 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.96% 6/627 • Number of events 6 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.65% 4/618 • Number of events 4 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Aortic thrombosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.49% 3/618 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Lung opacity	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Renal and urinary disorders Acute kidney injury	8.1% 50/618 • Number of events 50 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	3.8% 24/627 • Number of events 24 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Renal and urinary disorders Bladder perforation	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Renal and urinary disorders Renal infarct	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Renal and urinary disorders Renal tubular necrosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Renal and urinary disorders Renal vein thrombosis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Renal and urinary disorders Urethral perforation	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Deep vein thrombosis	4.9% 30/618 • Number of events 32 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	3.3% 21/627 • Number of events 21 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Peripheral artery thrombosis	0.65% 4/618 • Number of events 5 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Arterial haemorrhage	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Jugular vein thrombosis	0.32% 2/618 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.80% 5/627 • Number of events 5 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Shock	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Embolism	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Embolism venous	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Haemorrhage	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Hypotension	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Pelvic venous thrombosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Peripheral arterial occlusive disease	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Peripheral ischaemia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Peripheral vein occlusion	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Subclavian artery thrombosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Thrombosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Vena cava thrombosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Shock haemorrhagic	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.96% 6/627 • Number of events 6 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Arterial thrombosis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Vascular disorders Venous thrombosis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Pneumonia	4.0% 25/618 • Number of events 25 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	4.3% 27/627 • Number of events 28 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Septic shock	1.3% 8/618 • Number of events 8 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	1.3% 8/627 • Number of events 8 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Sepsis	0.81% 5/618 • Number of events 6 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.80% 5/627 • Number of events 6 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Abdominal abscess	0.49% 3/618 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Pneumonia staphylococcal	0.49% 3/618 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Urinary tract infection	0.49% 3/618 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Bacteraemia	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Empyema	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Chest wall abscess	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Enterobacter pneumonia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Fungaemia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Infectious pleural effusion	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Necrotising soft tissue infection	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Pneumonia necrotising	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Pneumonia pseudomonal	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Retroperitoneal abscess	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Systemic candida	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Abdominal infection	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.48% 3/627 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Clostridium difficile infection	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Liver abscess	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Candida infection	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Lung abscess	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Pneumonia klebsiella	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Post procedural sepsis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Stenotrophomonas infection	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Infections and infestations Wound infection	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
General disorders Multiple organ dysfunction syndrome	7.0% 43/618 • Number of events 44 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	5.7% 36/627 • Number of events 36 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
General disorders Systemic inflammatory response syndrome	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
General disorders Dehiscence	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Cerebrovascular accident	0.97% 6/618 • Number of events 6 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.48% 3/627 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Cerebral infarction	0.49% 3/618 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.48% 3/627 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Embolic stroke	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Intracranial pressure increased	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Parietal lobe stroke	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Carotid artery thrombosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Cerebellar infarction	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Cerebral artery embolism	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Cerebral haemorrhage	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Diplegia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Encephalopathy	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Ischaemic cerebral infarction	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Ischaemic stroke	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Middle cerebral artery stroke	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Seizure	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Brain oedema	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Brain injury	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Cerebral artery occlusion	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Haemorrhagic transformation stroke	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Paroxysmal sympathetic hyperactivity	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Spinal epidural haemorrhage	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Nervous system disorders Thalamic infarction	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Cardiac arrest	1.3% 8/618 • Number of events 9 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	1.1% 7/627 • Number of events 8 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Acute myocardial infarction	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Cardiac tamponade	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Acute coronary syndrome	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Bradycardia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Cardiac dysfunction	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Cardio-respiratory arrest	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Myocardial ischaemia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Supraventricular tachycardia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Atrial fibrillation	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Pericarditis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Cardiac disorders Right ventricular failure	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Craniocerebral injury	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Anaphylactic transfusion reaction	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Aortic injury	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Arterial injury	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Failure to anastomose	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Fat embolism	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Gastrointestinal injury	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Post transfusion purpura	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Seroma	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Transfusion-related acute lung injury	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Traumatic haemothorax	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Pancreatic leak	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Postoperative wound complication	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Subdural haematoma	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Ureteric injury	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.16% 1/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Anastomotic ulcer	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Injury, poisoning and procedural complications Abdominal wall wound	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.49% 3/618 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Intestinal perforation	0.49% 3/618 • Number of events 3 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Gastric fistula	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Gastric perforation	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Gastrointestinal necrosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Ileus	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Intestinal ischaemia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Melaena	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Small intestinal perforation	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Abdominal compartment syndrome	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Mesenteric artery thrombosis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Gastritis erosive	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Gastroduodenal haemorrhage	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Procedural pancreatitis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Blood and lymphatic system disorders Blood loss anaemia	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.48% 3/627 • Number of events 4 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Blood and lymphatic system disorders Thrombocytopenia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Blood and lymphatic system disorders Anaemia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Blood and lymphatic system disorders Thrombocytosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Hepatobiliary disorders Hepatic vein thrombosis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Hepatobiliary disorders Liver injury	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Hepatobiliary disorders Hepatic necrosis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Hepatobiliary disorders Acute cholecystitis necrotic	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Hepatobiliary disorders Perforation bile duct	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Reproductive system and breast disorders Pelvic fluid collection	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Skin and subcutaneous tissue disorders Urticaria	0.32% 2/618 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.32% 2/627 • Number of events 2 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Skin and subcutaneous tissue disorders Rash	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Congenital, familial and genetic disorders Antithrombin III deficiency	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Investigations International normalised ratio increased	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Investigations Haemoglobin decreased	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Investigations Oxygen saturation decreased	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Investigations Platelet count decreased	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Investigations Troponin increased	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Investigations White blood cell count increased	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Metabolism and nutrition disorders Hyperkalaemia	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.16% 1/618 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.00% 0/627 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Psychiatric disorders Mental status changes	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Psychiatric disorders Suicidal ideation	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.
Immune system disorders Anaphylactic reaction	0.00% 0/618 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	0.16% 1/627 • Number of events 1 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.

Other adverse events

Measure	BE1116 n=618 participants at risk Participants received a single administration of BE1116 via IV administration on Day 1.	Placebo n=627 participants at risk Participants received IV administration of placebo matched to BE1116.
Vascular disorders Deep vein thrombosis	5.2% 32/618 • Number of events 41 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.	6.2% 39/627 • Number of events 44 • Up to 30 days after randomization The safety analysis (analyses of serious adverse events (SAEs) and non-serious adverse events) is based on the Safety Population, which included all participants who received at least one complete or partial dose of BE1116 or placebo. All-cause mortality data were analyzed using the ITT population, comprising all randomized participants, classified according to their randomized treatment assignments.

Additional Information

Study Director

CSL Behring

Phone: 16108784000

Email: clinicaltrials@cslbehring.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place