Trial Outcomes & Findings for Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial (NCT NCT02508649)

NCT ID: NCT02508649

Last Updated: 2021-04-06

Results Overview

Composite endpoint defined as number of days from start of treatment to 30 days thereafter during which subject is: 1. Alive. However, if patient dies within these 30-days then PVFDs will be zero even if there is a period during which subject is alive and free of both vasopressor treatment and mechanical ventilation; 2. Free of treatment with vasopressors: Less than 60 min during any contiguous 24-h period. If a patient requires vasopressors longer than 60 min in total during any 24-h period, the intervening intervals during which they are free of vasopressors will not be included in the determination of PVFDs; 3. Free of any mechanical ventilation: Less than 60 min during any contiguous 24-h period. If a patient requires mechanical ventilation longer than 60 min in total during any 24-h period, the intervening intervals during which they are not receiving mechanical ventilation will not be included in the period free of mechanical ventilation in the determination of PVFDs.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 868 participants
• Primary outcome timeframe: Up to Day 30
• Results posted on: 2021-04-06

Participant Flow

A total of 63 sites were authorized to recruit subjects for the trial between July 2015 and August 2017. Eleven of these sites did not recruit any subjects. The trial sites that randomized subjects to the trial were: 11 in Belgium, 5 in Denmark, 17 in France, 5 in the Netherlands, and 14 in the United States of America (USA).

A total of 6377 subjects were screened, of which 868 subjects were randomized (585 subjects were allocated to selepressin [three doses] and 283 subjects were allocated to placebo). Up to four dosing regimens of selepressin were planned to be investigated in the trial. However, the highest dosing regimen was not used.

Participant milestones

Measure	Placebo Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin 2.5 ng/kg/Min Starting dose: 1.7 ng/kg/min selepressin; Maximum dose: 2.5 ng/kg/min selepressin, given as an infusion.	Selepressin 3.75 ng/kg/Min Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.
Overall Study STARTED	283	197	189	199
Overall Study Dosed	266	191	177	194
Overall Study COMPLETED	265	184	174	189
Overall Study NOT COMPLETED	18	13	15	10

Reasons for withdrawal

Measure	Placebo Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin 2.5 ng/kg/Min Starting dose: 1.7 ng/kg/min selepressin; Maximum dose: 2.5 ng/kg/min selepressin, given as an infusion.	Selepressin 3.75 ng/kg/Min Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.
Overall Study Withdrawal by Subject	4	6	5	6
Overall Study Investigator withdrew the subject	1	2	1	0
Overall Study Post randomization screening failure	12	4	9	3
Overall Study Lost to Follow-up	1	1	0	1

Baseline Characteristics

Number analyzed differs from the overall population as baseline body mass index (BMI) was not calculated for some of the subjects. The reason is that data was not collected for all subjects.

Baseline characteristics by cohort

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin 2.5 ng/kg/Min n=191 Participants Starting dose: 1.7 ng/kg/min selepressin; Maximum dose: 2.5 ng/kg/min selepressin, given as an infusion.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Total n=828 Participants Total of all reporting groups
Age, Continuous	65.7 years STANDARD_DEVIATION 14.56 • n=266 Participants	66.0 years STANDARD_DEVIATION 12.76 • n=191 Participants	67.2 years STANDARD_DEVIATION 13.13 • n=177 Participants	66.8 years STANDARD_DEVIATION 12.47 • n=194 Participants	66.3 years STANDARD_DEVIATION 13.37 • n=828 Participants
Sex: Female, Male Female	121 Participants n=266 Participants	80 Participants n=191 Participants	70 Participants n=177 Participants	70 Participants n=194 Participants	341 Participants n=828 Participants
Sex: Female, Male Male	145 Participants n=266 Participants	111 Participants n=191 Participants	107 Participants n=177 Participants	124 Participants n=194 Participants	487 Participants n=828 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=266 Participants	3 Participants n=191 Participants	1 Participants n=177 Participants	4 Participants n=194 Participants	12 Participants n=828 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	262 Participants n=266 Participants	188 Participants n=191 Participants	176 Participants n=177 Participants	190 Participants n=194 Participants	816 Participants n=828 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=266 Participants	0 Participants n=191 Participants	0 Participants n=177 Participants	0 Participants n=194 Participants	0 Participants n=828 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=266 Participants	0 Participants n=191 Participants	0 Participants n=177 Participants	0 Participants n=194 Participants	1 Participants n=828 Participants
Race (NIH/OMB) Asian	1 Participants n=266 Participants	2 Participants n=191 Participants	5 Participants n=177 Participants	4 Participants n=194 Participants	12 Participants n=828 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=266 Participants	0 Participants n=191 Participants	0 Participants n=177 Participants	0 Participants n=194 Participants	0 Participants n=828 Participants
Race (NIH/OMB) Black or African American	4 Participants n=266 Participants	3 Participants n=191 Participants	11 Participants n=177 Participants	7 Participants n=194 Participants	25 Participants n=828 Participants
Race (NIH/OMB) White	260 Participants n=266 Participants	186 Participants n=191 Participants	161 Participants n=177 Participants	183 Participants n=194 Participants	790 Participants n=828 Participants
Race (NIH/OMB) More than one race	0 Participants n=266 Participants	0 Participants n=191 Participants	0 Participants n=177 Participants	0 Participants n=194 Participants	0 Participants n=828 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=266 Participants	0 Participants n=191 Participants	0 Participants n=177 Participants	0 Participants n=194 Participants	0 Participants n=828 Participants
Baseline BMI	27.47 kg/m^2 STANDARD_DEVIATION 7.234 • n=265 Participants • Number analyzed differs from the overall population as baseline body mass index (BMI) was not calculated for some of the subjects. The reason is that data was not collected for all subjects.	27.56 kg/m^2 STANDARD_DEVIATION 8.778 • n=191 Participants • Number analyzed differs from the overall population as baseline body mass index (BMI) was not calculated for some of the subjects. The reason is that data was not collected for all subjects.	28.04 kg/m^2 STANDARD_DEVIATION 7.885 • n=176 Participants • Number analyzed differs from the overall population as baseline body mass index (BMI) was not calculated for some of the subjects. The reason is that data was not collected for all subjects.	27.98 kg/m^2 STANDARD_DEVIATION 8.565 • n=192 Participants • Number analyzed differs from the overall population as baseline body mass index (BMI) was not calculated for some of the subjects. The reason is that data was not collected for all subjects.	27.73 kg/m^2 STANDARD_DEVIATION 8.055 • n=824 Participants • Number analyzed differs from the overall population as baseline body mass index (BMI) was not calculated for some of the subjects. The reason is that data was not collected for all subjects.

PRIMARY outcome

Timeframe: Up to Day 30

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error.

Composite endpoint defined as number of days from start of treatment to 30 days thereafter during which subject is:

1. Alive. However, if patient dies within these 30-days then PVFDs will be zero even if there is a period during which subject is alive and free of both vasopressor treatment and mechanical ventilation;

2. Free of treatment with vasopressors: Less than 60 min during any contiguous 24-h period. If a patient requires vasopressors longer than 60 min in total during any 24-h period, the intervening intervals during which they are free of vasopressors will not be included in the determination of PVFDs;

3. Free of any mechanical ventilation: Less than 60 min during any contiguous 24-h period. If a patient requires mechanical ventilation longer than 60 min in total during any 24-h period, the intervening intervals during which they are not receiving mechanical ventilation will not be included in the period free of mechanical ventilation in the determination of PVFDs.

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled All selepressin arms pooled together and treated as a single arm.
Vasopressor- and Mechanical Ventilator-free Days (PVFDs)	14.45 days Interval 12.82 to 16.09	15.00 days Interval 13.77 to 16.23	—	—	—

SECONDARY outcome

Timeframe: At Day 90

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error.

All-cause mortality defined as the percentage of subjects that have died, regardless of cause.

Outcome measures

Measure	Placebo n=257 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=526 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled All selepressin arms pooled together and treated as a single arm.
All-cause Mortality	39.44 percentage of subjects	40.59 percentage of subjects	—	—	—

SECONDARY outcome

Timeframe: Up to Day 30

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error.

RRT-free days was defined as the number of days a subject is free of treatment with any form of RRT (continuous RRT, intermittent hemodialysis or peritoneal dialysis) and the intermittent periods were not included.

RRT-free days was analyzed excluding subjects on RRT for chronic renal failure at time of randomization.

Outcome measures

Measure	Placebo n=261 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=550 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled All selepressin arms pooled together and treated as a single arm.
Renal Replacement Therapy (RRT)-Free Days	18.21 days Interval 16.14 to 20.29	18.50 days Interval 17.03 to 19.98	—	—	—

SECONDARY outcome

Timeframe: Up to Day 30

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error.

The ICU free days, as for the PVFDs, reflect the time from last discharge of the ICU to Day 30 with an absolute penalty for mortality, i.e., any subject that died within this 30-day period was assigned zero value).

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled All selepressin arms pooled together and treated as a single arm.
Intensive Care Unit (ICU)-Free Days	12.15 days Interval 10.66 to 13.64	12.64 days Interval 11.51 to 13.76	—	—	—

SECONDARY outcome

Timeframe: Up to Day 30

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

Number of days from start of treatment to 30 days thereafter during which the subject is free of treatment with vasopressors, i.e. less than 60 min during any contiguous 24-h period.

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
Vasopressor-free Days up to Day 30	25.30 days Interval 0.0 to 28.3	25.60 days Interval 0.0 to 28.6	23.30 days Interval 0.0 to 28.6	25.30 days Interval 0.0 to 28.8	25.10 days Interval 0.0 to 28.7

SECONDARY outcome

Timeframe: Up to Day 30

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

Number of days from start of treatment to 30 days thereafter during which the subject is free of any mechanical ventilation, i.e. less than 60 min during any contiguous 24-h period.

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
Mechanical Ventilator-free Days up to Day 30	19.80 days Interval 0.0 to 29.4	18.90 days Interval 0.0 to 30.0	17.20 days Interval 0.0 to 29.1	17.50 days Interval 0.0 to 29.5	17.50 days Interval 0.0 to 29.8

SECONDARY outcome

Timeframe: Up to Day 30

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

The duration of septic shock was defined as the cumulative periods (>1 h), from start of investigational medicinal product (IMP) treatment until Day 30, on IMP or vasopressors.

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
Duration of Septic Shock (i.e. Vasopressor Use) up to Day 30	2.220 days Interval 1.11 to 4.42	1.660 days Interval 0.8 to 2.99	1.790 days Interval 0.81 to 4.37	1.465 days Interval 0.75 to 3.53	1.635 days Interval 0.77 to 3.65

SECONDARY outcome

Timeframe: Up to Day 30

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

The duration of mechanical ventilation was defined as the cumulative periods (>1 h), from start of the IMP treatment until Day 30, on mechanical ventilation.

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
Duration of Mechanical Ventilation up to Day 30	2.255 days Interval 0.0 to 8.71	1.690 days Interval 0.0 to 8.25	2.800 days Interval 0.1 to 8.88	1.910 days Interval 0.0 to 7.68	1.990 days Interval 0.0 to 8.25

SECONDARY outcome

Timeframe: Up to Day 30

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

Renal replacement therapy is defined as continuous RRT, intermittent hemodialysis, or peritoneal dialysis. In order to ensure that any reduction in the incidence of RRT was not caused by an increase in mortality, all subjects dying within the 30-day period were counted as on RRT.

Outcome measures

Measure	Placebo n=261 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=187 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=174 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=189 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=550 Participants All selepressin arms pooled together and treated as a single arm.
The Percentage of Subjects With RRT up to Day 30 (Counting Subjects Who Died as on RRT and Excluding Subjects on RRT for Chronic Renal Failure at the Time of Randomization) No	135 Participants	102 Participants	89 Participants	100 Participants	291 Participants
The Percentage of Subjects With RRT up to Day 30 (Counting Subjects Who Died as on RRT and Excluding Subjects on RRT for Chronic Renal Failure at the Time of Randomization) Yes	126 Participants	85 Participants	85 Participants	89 Participants	259 Participants

SECONDARY outcome

Timeframe: Up to Day 90

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

The duration of RRT was defined as the cumulative periods (>1 h) from start of IMP until Day 90 with RRT (continuous renal replacement therapy, intermittent hemodialysis, or peritoneal dialysis).

Subjects on RRT for chronic renal failure at time of randomization were not included in the analysis.

Outcome measures

Measure	Placebo n=261 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=187 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=174 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=189 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=550 Participants All selepressin arms pooled together and treated as a single arm.
Duration of RRT up to Day 90 (Excluding Subjects on RRT for Chronic Failure at the Time of Randomization)	1.634 days Standard Deviation 5.5380	1.739 days Standard Deviation 5.5593	1.876 days Standard Deviation 6.0300	2.459 days Standard Deviation 10.1365	2.030 days Standard Deviation 7.5640

SECONDARY outcome

Timeframe: Days 1, 3, and 7 or discharge from ICU

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error.

The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a modified Sequential Organ Failure Assessment (SOFA) (i.e. SOFA except the Glasgow Coma Scale). In addition, any dose of vasopressors or positive ionotropes will attribute 3 or 2 points on the cardiovascular scale, respectively.

Each organ has a possible dysfunction score of 0 (no organ dysfunction) to 4 (dysfunctional organ), for a total modified SOFA score range of 0 (no organ dysfunction) to 23 (all organs with dysfunction).

Outcome measures

Measure	Placebo n=263 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=555 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled All selepressin arms pooled together and treated as a single arm.
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Liver) score Day 7	1.17 score on a scale Interval 1.0 to 1.35	1.35 score on a scale Interval 1.23 to 1.46	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Overall score (Day 1)	9.95 score on a scale Interval 9.31 to 10.6	9.44 score on a scale Interval 9.0 to 9.89	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Overall score (Day 3)	8.95 score on a scale Interval 8.3 to 9.59	9.06 score on a scale Interval 8.6 to 9.51	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Overall score (Day 7)	8.08 score on a scale Interval 7.41 to 8.76	8.63 score on a scale Interval 8.17 to 9.1	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Respiratory) score Day 1	2.58 score on a scale Interval 2.45 to 2.71	2.50 score on a scale Interval 2.41 to 2.59	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Respiratory) score Day 3	2.43 score on a scale Interval 2.3 to 2.56	2.40 score on a scale Interval 2.31 to 2.49	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Respiratory) score Day 7	2.38 score on a scale Interval 2.24 to 2.52	2.41 score on a scale Interval 2.31 to 2.5	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Cardiovascular) score Day 1	3.66 score on a scale Interval 3.47 to 3.85	3.23 score on a scale Interval 3.1 to 3.36	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Cardiovascular) score Day 3	2.33 score on a scale Interval 2.14 to 2.53	2.08 score on a scale Interval 1.95 to 2.22	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Cardiovascular) score Day 7	1.79 score on a scale Interval 1.58 to 1.99	1.65 score on a scale Interval 1.51 to 1.79	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Renal) score Day 1	1.64 score on a scale Interval 1.47 to 1.81	1.59 score on a scale Interval 1.48 to 1.71	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Renal) score Day 3	1.52 score on a scale Interval 1.35 to 1.69	1.61 score on a scale Interval 1.49 to 1.73	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Renal) score Day 7	1.46 score on a scale Interval 1.28 to 1.64	1.63 score on a scale Interval 1.5 to 1.75	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Coagulation) score Day 1	1.15 score on a scale Interval 1.0 to 1.3	1.27 score on a scale Interval 1.16 to 1.37	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Coagulation) score Day 3	1.50 score on a scale Interval 1.35 to 1.66	1.73 score on a scale Interval 1.62 to 1.84	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Coagulation) score Day 7	1.30 score on a scale Interval 1.14 to 1.46	1.53 score on a scale Interval 1.42 to 1.64	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Liver) score Day 1	0.87 score on a scale Interval 0.71 to 1.03	0.72 score on a scale Interval 0.61 to 0.83	—	—	—
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge Individual (Liver) score Day 3	1.11 score on a scale Interval 0.95 to 1.28	1.07 score on a scale Interval 0.95 to 1.18	—	—	—

SECONDARY outcome

Timeframe: Up to Day 7 and Day 30

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error.

The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a SOFA score. Each organ has a possible dysfunction score of 0 (no organ dysfunction) to 4 (all organs with dysfunction).

Incidence of new organ dysfunction is defined as an increase ≥ 1 from baseline to post baseline up until the end of the period (e.g. going from 1-2) in any of the individual SOFA scores.

Incidence of new organ failures is defined as a change in any of the individual SOFA scores from (0-2) at baseline to (3-4) post baseline up until the end of the period (Day 7 or 30) (if the SOFA scores goes from (0-2) to (3-4) and back to (0-2) again within the period, that will still count as a new organ failure).

Percentage of subjects with new organ dysfunction and new organ failure (based on the SOFA Score) up to Day 7 and Day 30 are reported.

Outcome measures

Measure	Placebo n=256 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=536 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled All selepressin arms pooled together and treated as a single arm.
Percentage of Subjects With New Organ Dysfunction and New Organ Failure (Based on the SOFA Score) up to Day 7 and Day 30 New organ dysfunction (Day 7)	76.41 percentage of subjects Interval 70.42 to 81.51	81.95 percentage of subjects Interval 77.92 to 85.38	—	—	—
Percentage of Subjects With New Organ Dysfunction and New Organ Failure (Based on the SOFA Score) up to Day 7 and Day 30 New organ dysfunction (Day 30)	80.44 percentage of subjects Interval 74.8 to 85.07	84.08 percentage of subjects Interval 80.21 to 87.31	—	—	—
Percentage of Subjects With New Organ Dysfunction and New Organ Failure (Based on the SOFA Score) up to Day 7 and Day 30 New organ failure (Day 7)	44.18 percentage of subjects Interval 37.67 to 50.9	47.39 percentage of subjects Interval 42.7 to 52.12	—	—	—
Percentage of Subjects With New Organ Dysfunction and New Organ Failure (Based on the SOFA Score) up to Day 7 and Day 30 New organ failure (Day 30)	56.91 percentage of subjects Interval 50.23 to 63.35	57.15 percentage of subjects Interval 52.39 to 61.78	—	—	—

SECONDARY outcome

Timeframe: Up to Day 30

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

ICU length of stay is defined as the cumulative periods (>1 h) spent in ICU from start of IMP to 30 days after.

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
ICU Length of Stay up to Day 30	6.755 days Interval 3.11 to 16.11	4.940 days Interval 2.5 to 13.53	6.460 days Interval 2.88 to 15.53	5.960 days Interval 2.79 to 14.38	5.695 days Interval 2.71 to 14.43

SECONDARY outcome

Timeframe: At Day 30 and Day 180

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

All-cause mortality defined as the percentage of subjects that have died, regardless of cause.

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
All-cause Mortality (Defined as the Percentage of Subjects That Have Died, Regardless of Cause) at Day 30 and Day 180 Day 180 · No	147 Participants	104 Participants	96 Participants	102 Participants	302 Participants
All-cause Mortality (Defined as the Percentage of Subjects That Have Died, Regardless of Cause) at Day 30 and Day 180 Day 180 · Yes	116 Participants	80 Participants	76 Participants	85 Participants	241 Participants
All-cause Mortality (Defined as the Percentage of Subjects That Have Died, Regardless of Cause) at Day 30 and Day 180 Day 30 · No	174 Participants	121 Participants	114 Participants	124 Participants	359 Participants
All-cause Mortality (Defined as the Percentage of Subjects That Have Died, Regardless of Cause) at Day 30 and Day 180 Day 30 · Yes	91 Participants	66 Participants	62 Participants	65 Participants	193 Participants

SECONDARY outcome

Timeframe: Baseline and Days 1-7

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

Fluid balance (as a rate of time) calculated for fluid administered during episode of severe sepsis/septic shock will be presented until ICU discharge (for a maximum of 7 days).

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 1	104.74 mL/h Standard Deviation 110.40	95.14 mL/h Standard Deviation 116.90	86.80 mL/h Standard Deviation 111.86	66.68 mL/h Standard Deviation 96.94	82.68 mL/h Standard Deviation 109.24
Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 2	51.78 mL/h Standard Deviation 79.27	52.75 mL/h Standard Deviation 74.12	48.95 mL/h Standard Deviation 65.47	44.35 mL/h Standard Deviation 73.82	48.62 mL/h Standard Deviation 71.39
Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 3	19.71 mL/h Standard Deviation 79.94	24.87 mL/h Standard Deviation 65.20	33.34 mL/h Standard Deviation 67.61	29.14 mL/h Standard Deviation 75.19	29.11 mL/h Standard Deviation 69.52
Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 4	2.34 mL/h Standard Deviation 75.41	6.76 mL/h Standard Deviation 59.14	22.28 mL/h Standard Deviation 70.95	19.50 mL/h Standard Deviation 66.09	16.25 mL/h Standard Deviation 65.76
Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 5	-0.30 mL/h Standard Deviation 72.84	1.08 mL/h Standard Deviation 62.02	5.94 mL/h Standard Deviation 71.72	3.06 mL/h Standard Deviation 62.49	3.41 mL/h Standard Deviation 65.40
Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 6	-4.70 mL/h Standard Deviation 61.16	-12.19 mL/h Standard Deviation 80.30	-3.49 mL/h Standard Deviation 75.52	-5.91 mL/h Standard Deviation 64.72	-7.05 mL/h Standard Deviation 73.03
Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 7	-5.84 mL/h Standard Deviation 62.52	-7.36 mL/h Standard Deviation 63.51	4.17 mL/h Standard Deviation 67.38	-12.71 mL/h Standard Deviation 58.19	-5.55 mL/h Standard Deviation 63.12
Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Baseline	339.10 mL/h Standard Deviation 236.53	342.23 mL/h Standard Deviation 218.17	365.14 mL/h Standard Deviation 255.92	350.51 mL/h Standard Deviation 278.28	352.38 mL/h Standard Deviation 252.01

SECONDARY outcome

Timeframe: Baseline and Days 1-7

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

Cumulative fluid balance (total volume) calculated for fluid administered during episode of severe sepsis/septic shock will be presented until ICU discharge (for a maximum of 7 days).

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Baseline	3715.19 mL Standard Deviation 2191.23	4043.77 mL Standard Deviation 2650.73	4250.88 mL Standard Deviation 2943.81	3874.96 mL Standard Deviation 2499.80	4050.78 mL Standard Deviation 2696.92
Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 1	2513.84 mL Standard Deviation 2649.60	2283.24 mL Standard Deviation 2805.64	2083.09 mL Standard Deviation 2684.72	1600.21 mL Standard Deviation 2326.52	1984.43 mL Standard Deviation 2621.80
Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 2	3688.96 mL Standard Deviation 4071.55	3470.11 mL Standard Deviation 4148.24	3114.71 mL Standard Deviation 3588.75	2584.89 mL Standard Deviation 3621.66	3049.40 mL Standard Deviation 3809.45
Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 3	4179.02 mL Standard Deviation 5054.24	4020.24 mL Standard Deviation 4939.49	3684.97 mL Standard Deviation 4584.27	3212.04 mL Standard Deviation 4932.67	3630.48 mL Standard Deviation 4825.32
Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 4	4347.58 mL Standard Deviation 6027.04	4094.19 mL Standard Deviation 5122.49	4633.22 mL Standard Deviation 5855.47	3880.32 mL Standard Deviation 5643.93	4195.31 mL Standard Deviation 5546.47
Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 5	4600.67 mL Standard Deviation 6723.02	4307.39 mL Standard Deviation 5636.37	5126.22 mL Standard Deviation 6910.78	4079.52 mL Standard Deviation 6367.01	4497.16 mL Standard Deviation 6342.44
Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 6	4750.10 mL Standard Deviation 7322.08	4312.81 mL Standard Deviation 6564.90	5263.21 mL Standard Deviation 7595.18	4224.47 mL Standard Deviation 7163.95	4582.04 mL Standard Deviation 7121.18
Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days) Day 7	4978.66 mL Standard Deviation 7803.61	4418.66 mL Standard Deviation 7263.42	5628.59 mL Standard Deviation 8471.78	4425.98 mL Standard Deviation 7977.33	4814.08 mL Standard Deviation 7919.51

SECONDARY outcome

Timeframe: Baseline and Days 1-7

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days) Baseline	73.726 mL/h Standard Deviation 94.7641	72.944 mL/h Standard Deviation 82.3338	74.530 mL/h Standard Deviation 92.8984	83.773 mL/h Standard Deviation 86.5417	77.212 mL/h Standard Deviation 87.2301
Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 1	85.277 mL/h Standard Deviation 70.3224	101.270 mL/h Standard Deviation 80.4142	94.290 mL/h Standard Deviation 70.9804	104.049 mL/h Standard Deviation 75.8876	100.031 mL/h Standard Deviation 75.9501
Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 2	88.425 mL/h Standard Deviation 61.2134	89.404 mL/h Standard Deviation 64.9307	88.210 mL/h Standard Deviation 59.6632	92.400 mL/h Standard Deviation 61.8536	90.085 mL/h Standard Deviation 62.1593
Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 3	104.124 mL/h Standard Deviation 67.7586	104.833 mL/h Standard Deviation 66.4533	85.403 mL/h Standard Deviation 61.5660	97.312 mL/h Standard Deviation 67.8895	95.902 mL/h Standard Deviation 65.7529
Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 4	110.078 mL/h Standard Deviation 73.3563	103.459 mL/h Standard Deviation 69.8165	92.311 mL/h Standard Deviation 65.0558	102.859 mL/h Standard Deviation 64.2044	99.618 mL/h Standard Deviation 66.3843
Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 5	116.732 mL/h Standard Deviation 65.1159	110.129 mL/h Standard Deviation 65.7571	100.581 mL/h Standard Deviation 75.5667	117.152 mL/h Standard Deviation 68.3988	109.494 mL/h Standard Deviation 70.2288
Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 6	119.087 mL/h Standard Deviation 65.7102	126.512 mL/h Standard Deviation 83.3418	116.799 mL/h Standard Deviation 79.3092	118.269 mL/h Standard Deviation 72.2910	120.311 mL/h Standard Deviation 77.8633
Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 7	116.082 mL/h Standard Deviation 65.9402	121.751 mL/h Standard Deviation 68.1265	111.499 mL/h Standard Deviation 72.8493	114.284 mL/h Standard Deviation 69.5828	115.720 mL/h Standard Deviation 70.0786

SECONDARY outcome

Timeframe: Baseline and Days 1-7

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

Cumulative urinary output (absolute values) will be presented until ICU discharge (for a maximum of 7 Days).

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 3	6885.176 mL Standard Deviation 4100.2125	7527.805 mL Standard Deviation 4401.3731	6587.704 mL Standard Deviation 3849.2099	7322.964 mL Standard Deviation 4322.9651	7150.914 mL Standard Deviation 4211.3049
Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 6	15159.980 mL Standard Deviation 7264.4502	16354.712 mL Standard Deviation 7864.2281	14522.098 mL Standard Deviation 7391.7707	15674.783 mL Standard Deviation 7202.3158	15514.875 mL Standard Deviation 7479.2644
Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 7	17817.979 mL Standard Deviation 8226.0238	19269.682 mL Standard Deviation 9081.2013	17034.774 mL Standard Deviation 8635.0531	18380.119 mL Standard Deviation 8479.7547	18222.202 mL Standard Deviation 8736.1728
Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days) Baseline	888.834 mL Standard Deviation 1197.4426	898.056 mL Standard Deviation 1020.7890	947.843 mL Standard Deviation 1264.9054	1017.646 mL Standard Deviation 1076.2691	955.426 mL Standard Deviation 1121.3215
Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 1	2046.658 mL Standard Deviation 1687.7381	2430.485 mL Standard Deviation 1929.9400	2262.948 mL Standard Deviation 1703.5290	2497.173 mL Standard Deviation 1821.3014	2400.740 mL Standard Deviation 1822.8019
Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 2	4343.786 mL Standard Deviation 2909.9212	4702.538 mL Standard Deviation 3199.5558	4534.714 mL Standard Deviation 2825.1740	4814.544 mL Standard Deviation 3091.7350	4689.788 mL Standard Deviation 3045.8065
Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 4	9501.722 mL Standard Deviation 5247.5530	10239.275 mL Standard Deviation 5486.1180	8786.522 mL Standard Deviation 5086.7347	9851.841 mL Standard Deviation 5478.3671	9630.976 mL Standard Deviation 5377.6356
Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days) Day 5	12600.503 mL Standard Deviation 6293.7322	13219.597 mL Standard Deviation 6695.6766	11132.418 mL Standard Deviation 6230.4688	12795.773 mL Standard Deviation 6400.6821	12372.680 mL Standard Deviation 6480.0818

SECONDARY outcome

Timeframe: Baseline and Days 30, 60, 90 and 180

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

The EuroQoL-5-Dimensions (EQ-5D™) was used to assess the overall health of each subject. EQ-5D™ is a standardised instrument for use as a measure of health outcome. The first part of the instrument includes 5 dimensions where the subject indicates which of the given statements best describes the health state on the day of questionnaire completion. The second part contains a visual analogue scale (VAS) where the subject indicates how good or bad his or her own health is on the day of questionnaire completion.

EQ-5D-5L will be analyzed by the index value (Range: 0-1; 0=dead state, 1=full health state), the overall quality-adjusted life year (QALY), and the VAS score (Range: 0-100; 0=worst health state, 100=best health state). The EQ-5D-5L was completed at baseline and at the scheduled follow-up days (i.e. Day 30, Day 60, Day 90, and Day 180).

Data for EQ VAS score and EQ-5D-5L index score are reported in this endpoint.

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ VAS score (Day 30)	59.4 score on a scale Standard Deviation 21.21	54.7 score on a scale Standard Deviation 21.12	53.8 score on a scale Standard Deviation 19.63	53.9 score on a scale Standard Deviation 23.99	54.2 score on a scale Standard Deviation 21.65
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ VAS score (Day 90)	68.2 score on a scale Standard Deviation 19.61	65.9 score on a scale Standard Deviation 20.70	67.0 score on a scale Standard Deviation 17.50	68.1 score on a scale Standard Deviation 18.63	67.0 score on a scale Standard Deviation 18.98
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ VAS score (Day 180)	72.6 score on a scale Standard Deviation 20.07	71.2 score on a scale Standard Deviation 18.55	67.4 score on a scale Standard Deviation 21.39	69.7 score on a scale Standard Deviation 20.29	69.5 score on a scale Standard Deviation 20.08
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ-5D-5L index score (Baseline)	0.7305 score on a scale Standard Deviation 0.25098	0.7648 score on a scale Standard Deviation 0.22393	0.7576 score on a scale Standard Deviation 0.23070	0.7380 score on a scale Standard Deviation 0.22152	0.7525 score on a scale Standard Deviation 0.22481
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ-5D-5L index score (Day 30)	0.5706 score on a scale Standard Deviation 0.29463	0.5600 score on a scale Standard Deviation 0.27848	0.5089 score on a scale Standard Deviation 0.29004	0.5283 score on a scale Standard Deviation 0.33580	0.5335 score on a scale Standard Deviation 0.30245
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ-5D-5L index score (Day 60)	0.6707 score on a scale Standard Deviation 0.26160	0.6788 score on a scale Standard Deviation 0.22544	0.6719 score on a scale Standard Deviation 0.21777	0.6746 score on a scale Standard Deviation 0.25391	0.6753 score on a scale Standard Deviation 0.23222
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ-5D-5L index score (Day 90)	0.7207 score on a scale Standard Deviation 0.22523	0.7018 score on a scale Standard Deviation 0.26544	0.7290 score on a scale Standard Deviation 0.21608	0.6810 score on a scale Standard Deviation 0.24960	0.7032 score on a scale Standard Deviation 0.24515
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ-5D-5L index score (Day 180)	0.7627 score on a scale Standard Deviation 0.22170	0.7572 score on a scale Standard Deviation 0.19803	0.7409 score on a scale Standard Deviation 0.19813	0.7435 score on a scale Standard Deviation 0.23729	0.7472 score on a scale Standard Deviation 0.21112
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ VAS score (Baseline)	69.2 score on a scale Standard Deviation 21.13	69.9 score on a scale Standard Deviation 21.69	67.0 score on a scale Standard Deviation 21.60	67.4 score on a scale Standard Deviation 22.83	68.1 score on a scale Standard Deviation 22.07
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ VAS score (Day 60)	64.5 score on a scale Standard Deviation 20.58	62.6 score on a scale Standard Deviation 20.92	62.6 score on a scale Standard Deviation 18.94	63.8 score on a scale Standard Deviation 20.30	63.0 score on a scale Standard Deviation 20.04

SECONDARY outcome

Timeframe: Days 30, 60, 90 and 180

Population: The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed.

The EQ-5D™ was used to assess the overall health of each subject. EQ-5D™ is a standardised instrument for use as a measure of health outcome. The first part of the instrument includes 5 dimensions where the subject indicates which of the given statements best describes the health state on the day of questionnaire completion. The second part contains a VAS where the subject indicates how good or bad his or her own health is on the day of questionnaire completion.

EQ-5D-5L will be analyzed by the index value (Range: 0-1; 0=dead state, 1=full health state), the overall QALY, and the VAS score (Range: 0-100; 0=worst health state, 100=best health state). The EQ-5D-5L was completed at baseline and at the scheduled follow-up days (i.e. Day 30, Day 60, Day 90, and Day 180).

Data for EQ-5D-5L QALY is reported in this endpoint.

Outcome measures

Measure	Placebo n=266 Participants Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin Pooled n=191 Participants All selepressin arms pooled together and treated as a single arm.	Selepressin 3.75 ng/kg/Min n=177 Participants Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 Participants Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 Participants All selepressin arms pooled together and treated as a single arm.
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ-5D-5L QALY (Day 60)	0.088 Quality-adjusted life-year Standard Deviation 0.0683	0.093 Quality-adjusted life-year Standard Deviation 0.0588	0.085 Quality-adjusted life-year Standard Deviation 0.0548	0.084 Quality-adjusted life-year Standard Deviation 0.0643	0.087 Quality-adjusted life-year Standard Deviation 0.0595
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ-5D-5L QALY (Day 90)	0.144 Quality-adjusted life-year Standard Deviation 0.0819	0.146 Quality-adjusted life-year Standard Deviation 0.0725	0.145 Quality-adjusted life-year Standard Deviation 0.0670	0.139 Quality-adjusted life-year Standard Deviation 0.0760	0.143 Quality-adjusted life-year Standard Deviation 0.0718
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ-5D-5L QALY (Day 30)	0.036 Quality-adjusted life-year Standard Deviation 0.0558	0.039 Quality-adjusted life-year Standard Deviation 0.0448	0.033 Quality-adjusted life-year Standard Deviation 0.0388	0.030 Quality-adjusted life-year Standard Deviation 0.0501	0.034 Quality-adjusted life-year Standard Deviation 0.0451
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180 EQ-5D-5L QALY (Day 180)	0.330 Quality-adjusted life-year Standard Deviation 0.1174	0.338 Quality-adjusted life-year Standard Deviation 0.1239	0.329 Quality-adjusted life-year Standard Deviation 0.1011	0.319 Quality-adjusted life-year Standard Deviation 0.1155	0.328 Quality-adjusted life-year Standard Deviation 0.1137

Adverse Events

Placebo

Serious events: 85 serious events

Other events: 94 other events

Deaths: 116 deaths

Selepressin 2.5 ng/kg/Min

Serious events: 57 serious events

Other events: 54 other events

Deaths: 80 deaths

Selepressin 3.75 ng/kg/Min

Serious events: 65 serious events

Other events: 63 other events

Deaths: 76 deaths

Selepressin 5.25 ng/kg/Min

Serious events: 57 serious events

Other events: 60 other events

Deaths: 85 deaths

Selepressin Pooled

Serious events: 179 serious events

Other events: 177 other events

Deaths: 241 deaths

Serious adverse events

Measure	Placebo n=266 participants at risk Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin 2.5 ng/kg/Min n=191 participants at risk Starting dose: 1.7 ng/kg/min selepressin; Maximum dose: 2.5 ng/kg/min selepressin, given as an infusion.	Selepressin 3.75 ng/kg/Min n=177 participants at risk Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 participants at risk Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 participants at risk All selepressin arms pooled together and treated as a single arm.
Blood and lymphatic system disorders Anaemia	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Blood and lymphatic system disorders Haemolysis	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Blood and lymphatic system disorders Splenic necrosis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Cardiac arrest	1.1% 3/266 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	2.6% 5/191 • Number of events 7 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	2.8% 5/177 • Number of events 6 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	2.0% 11/562 • Number of events 14 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Myocardial ischaemia	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	2.3% 4/177 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.89% 5/562 • Number of events 5 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Acute myocardial infarction	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.0% 2/191 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.53% 3/562 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Cyanosis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.0% 2/194 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.53% 3/562 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Pulseless electrical activity	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.1% 2/177 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.53% 3/562 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Cardiac failure	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.0% 2/194 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.36% 2/562 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Cardiogenic shock	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.36% 2/562 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Supraventricular tachycardia	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.36% 2/562 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Acute coronary syndrome	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Atrial fibrillation	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Defect conduction intraventricular	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Myocardial depression	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Myocardial infarction	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Myocardial stunning	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Right ventricular failure	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Sinus bradycardia	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Tachycardia	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Ventricular arrhythmia	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Ventricular fibrillation	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Ventricular tachycardia	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Intestinal ischaemia	1.1% 3/266 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	2.1% 4/191 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.0% 2/194 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.2% 7/562 • Number of events 8 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Abdominal compartment syndrome	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Colonic fistula	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Duodenal perforation	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Gastric haemorrhage	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Gastrointestinal ischaemia	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Ileus	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Large intestine perforation	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Gastrointestinal disorders Peritoneal haemorrhage	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
General disorders Multiple organ dysfunction syndrome	9.0% 24/266 • Number of events 24 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	5.2% 10/191 • Number of events 10 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	9.6% 17/177 • Number of events 17 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	6.2% 12/194 • Number of events 12 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	6.9% 39/562 • Number of events 39 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
General disorders Catheter site haemorrhage	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
General disorders Disease progression	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
General disorders General physical health deterioration	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
General disorders Hyperthermia	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
General disorders Organ failure	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Hepatobiliary disorders Hepatic failure	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.36% 2/562 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Hepatobiliary disorders Cholecystitis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Hepatobiliary disorders Chronic hepatic failure	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Hepatobiliary disorders Gallbladder disorder	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Hepatobiliary disorders Hepatitis acute	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Septic shock	5.6% 15/266 • Number of events 15 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	5.2% 10/191 • Number of events 10 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	6.8% 12/177 • Number of events 12 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	4.1% 8/194 • Number of events 8 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	5.3% 30/562 • Number of events 30 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Pneumonia	1.5% 4/266 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.0% 2/191 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.1% 2/177 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.71% 4/562 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Sepsis	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.5% 3/194 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.71% 4/562 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Endocarditis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.53% 3/562 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Abscess	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Arthritis infective	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Cellulitis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Device related sepsis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Extradural abscess	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Klebsiella sepsis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Necrotising fasciitis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Infections and infestations Peritonitis bacterial	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.0% 2/191 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.36% 2/562 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Endotracheal intubation complication	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Investigations Cardiac output decreased	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Investigations Troponin I increased	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Investigations Troponin increased	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Hyperkalaemia	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Hyperlactacidaemia	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Fasciitis	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Nervous system disorders Encephalopathy	0.75% 2/266 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Nervous system disorders Brain oedema	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Nervous system disorders Cerebral ischaemia	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Nervous system disorders Coma	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Nervous system disorders Vasculitis cerebral	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Renal and urinary disorders Acute kidney injury	1.9% 5/266 • Number of events 5 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.1% 2/177 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.36% 2/562 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Renal and urinary disorders Renal failure	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.0% 2/194 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.53% 3/562 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.5% 4/266 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.6% 3/191 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.7% 3/177 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.2% 7/562 • Number of events 7 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 3/266 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	2.6% 5/194 • Number of events 5 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.1% 6/562 • Number of events 6 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.1% 2/177 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.53% 3/562 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Aspiration	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Mediastinal mass	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Skin discolouration	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.0% 2/191 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.1% 2/177 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.89% 5/562 • Number of events 5 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Peripheral ischaemia	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	2.3% 4/177 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.0% 2/194 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.2% 7/562 • Number of events 7 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Shock	1.5% 4/266 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.5% 3/194 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.89% 5/562 • Number of events 5 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Hypotension	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	1.5% 3/194 • Number of events 3 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.71% 4/562 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Shock haemorrhagic	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.36% 2/562 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Vasoconstriction	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.36% 2/562 • Number of events 2 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Circulatory collapse	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/191 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Distributive shock	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Dry gangrene	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Extremity necrosis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Hypertension	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.56% 1/177 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Ischaemia	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Poor peripheral circulation	0.38% 1/266 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/194 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/562 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Vascular disorders Thrombosis	0.00% 0/266 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/191 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.00% 0/177 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.52% 1/194 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	0.18% 1/562 • Number of events 1 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.

Other adverse events

Measure	Placebo n=266 participants at risk Sterile 0.9% sodium chloride solution given as an infusion, was used as the placebo.	Selepressin 2.5 ng/kg/Min n=191 participants at risk Starting dose: 1.7 ng/kg/min selepressin; Maximum dose: 2.5 ng/kg/min selepressin, given as an infusion.	Selepressin 3.75 ng/kg/Min n=177 participants at risk Starting dose: 2.5 ng/kg/min selepressin; Maximum dose: 3.75 ng/kg/min selepressin, given as an infusion.	Selepressin 5.25 ng/kg/Min n=194 participants at risk Starting dose: 3.5 ng/kg/min selepressin; Maximum dose: 5.25 ng/kg/min selepressin, given as an infusion.	Selepressin Pooled n=562 participants at risk All selepressin arms pooled together and treated as a single arm.
Blood and lymphatic system disorders Thrombocytopenia	4.5% 12/266 • Number of events 13 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	4.7% 9/191 • Number of events 9 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	5.6% 10/177 • Number of events 10 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	5.7% 11/194 • Number of events 11 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	5.3% 30/562 • Number of events 30 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Blood and lymphatic system disorders Anaemia	9.0% 24/266 • Number of events 25 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	6.3% 12/191 • Number of events 13 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	3.4% 6/177 • Number of events 6 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	3.6% 7/194 • Number of events 7 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	4.4% 25/562 • Number of events 26 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Cardiac disorders Atrial fibrillation	11.3% 30/266 • Number of events 43 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	11.5% 22/191 • Number of events 23 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	13.6% 24/177 • Number of events 27 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	11.3% 22/194 • Number of events 29 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	12.1% 68/562 • Number of events 79 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Expired product administered	18.8% 50/266 • Number of events 94 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	13.6% 26/191 • Number of events 48 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	16.4% 29/177 • Number of events 47 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	16.0% 31/194 • Number of events 62 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	15.3% 86/562 • Number of events 157 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Hypokalaemia	1.5% 4/266 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	2.6% 5/191 • Number of events 5 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	5.1% 9/177 • Number of events 9 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	2.1% 4/194 • Number of events 4 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.	3.2% 18/562 • Number of events 18 • All-cause mortality, defined as the percentage of subjects that have died regardless of cause, was recorded up to Day 180. Treatment-emergent adverse events (TEAEs) were collected during the treatment period, i.e., TEAEs occurring after IMP infusion to within 12 hours after the IMP infusion was stopped. All treated subjects were included in the safety analysis set and were analyzed according to the actual treatment received.

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