Trial Outcomes & Findings for Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia (NCT NCT04369469)

NCT ID: NCT04369469

Last Updated: 2022-05-24

Results Overview

Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 202 participants
• Primary outcome timeframe: Day 29
• Results posted on: 2022-05-24

Participant Flow

Of the 210 participants screened, 8 (3.8%) participants were screen failures. A total of 202 participants were randomized and treated.

Participant milestones

Measure	Group 1 - Ravulizumab + BSC Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone Participants received medications, therapies, and interventions per standard hospital treatment protocols
Overall Study STARTED	135	67
Overall Study Intent to Treat (ITT) Population	135	66
Overall Study Pharmacokinetic (PK)	127	52
Overall Study Safety Population	127	67
Overall Study COMPLETED	125	58
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Measure	Group 1 - Ravulizumab + BSC Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone Participants received medications, therapies, and interventions per standard hospital treatment protocols
Overall Study Lost to Follow-up	2	4
Overall Study Physician Decision	2	1
Overall Study Withdrawal by Subject	2	3
Overall Study Adverse Event	1	0
Overall Study Did Not Meet Inclusion/Exclusion Criteria	2	0
Overall Study Not Qualified due to History of Anaphylaxis	1	0
Overall Study Unable to Provide Consent	0	1

Baseline Characteristics

Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia

Baseline characteristics by cohort

Measure	Group 1 - Ravulizumab + BSC n=135 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=66 Participants Participants received medications, therapies, and interventions per standard hospital treatment protocols	Total n=201 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 13.23 • n=5 Participants	63.5 years STANDARD_DEVIATION 12.40 • n=7 Participants	63.3 years STANDARD_DEVIATION 12.93 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	23 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	43 Participants n=7 Participants	139 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	100 participants n=5 Participants	46 participants n=7 Participants	146 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	27 participants n=5 Participants	11 participants n=7 Participants	38 participants n=5 Participants
Race/Ethnicity, Customized Missing/Unknown	17 participants n=5 Participants	5 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Not reported	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized White	72 participants n=5 Participants	40 participants n=7 Participants	112 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	20 participants n=5 Participants	7 participants n=7 Participants	27 participants n=5 Participants
Race/Ethnicity, Customized Other	13 participants n=5 Participants	5 participants n=7 Participants	18 participants n=5 Participants
Race/Ethnicity, Customized Asian	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants
Race/Ethnicity, Customized Not Reported	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29

Population: The ITT Population consisted of all randomized participants. Participants were analyzed as randomized.

Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations.

Outcome measures

Measure	Group 1 - Ravulizumab + BSC n=135 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=66 Participants Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29	57.6 Percentage of participants	59.7 Percentage of participants

SECONDARY outcome

Timeframe: Day 29

Population: The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

The number of days free of mechanical ventilation was defined as the total number of days from Day 1 to Day 29 without invasive or non-invasive mechanical ventilation.

Outcome measures

Measure	Group 1 - Ravulizumab + BSC n=129 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=62 Participants Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Number Of Days Free Of Mechanical Ventilation At Day 29	6.79 Days Interval 4.79 to 8.8	6.81 Days Interval 4.19 to 9.43

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

The number of days that the participants were alive and not in the ICU from Day 1 through Day 29 are presented.

Outcome measures

Measure	Group 1 - Ravulizumab + BSC n=129 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=62 Participants Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Number of Days the Participants Were Alive and Not in ICU	6.09 Days Interval 4.31 to 7.87	6.71 Days Interval 4.38 to 9.03

SECONDARY outcome

Timeframe: Baseline, Day 29

Population: The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

Baseline was defined as the last available assessment on or before Day 1 for all participants. Participants were evaluated using the SOFA score, an assessment tool that included a review of 6 organ systems: respiratory, renal, hepatic, cardiac, coagulation, and central nervous system. Each organ system was scored from 0 to 4 points using the worst value observed within the previous 24 hours. The total score ranged from 0 to 24, with a higher score indicating a worse condition.

Outcome measures

Measure	Group 1 - Ravulizumab + BSC n=42 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=17 Participants Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29	-2.0 Units on a scale Standard Deviation 6.25	-4.5 Units on a scale Standard Deviation 4.90

SECONDARY outcome

Timeframe: Baseline, Day 29

Population: The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

Oxygenation was measured using the SpO2 and the amount of supplemental oxygen as measured by the FiO2 received by taking the ratio of these 2 measures at the same time point.

Outcome measures

Measure	Group 1 - Ravulizumab + BSC n=38 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=17 Participants Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29	62.5 ratio Standard Deviation 112.43	134.0 ratio Standard Deviation 104.35

SECONDARY outcome

Timeframe: Day 1 through Day 29

Population: The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

The number of days that the participants were alive and not in the hospital from Day 1 through Day 29 are presented.

Outcome measures

Measure	Group 1 - Ravulizumab + BSC n=129 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=62 Participants Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Number of Days the Participants Were Alive and Not in the Hospital	3.02 Days Interval 1.76 to 4.29	3.47 Days Interval 1.83 to 5.12

SECONDARY outcome

Timeframe: Up to Day 60 and Up to Day 90

Population: The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, "Number Analyzed" signifies those participants who were evaluable for the assessment at the specified time frame.

For this analysis, 2 participants in Group 1 (Ravulizumab + BSC) and 1 participant in Group 2 (BSC Alone) were censored at Day 90. The estimated number of participants alive for this analysis was calculated using the method of Kaplan and Meier (KM) and compared using a log-rank test stratified by intubated or not intubated on Day 1 as a sensitivity analysis. This Outcome Measure was designed to project an estimate of how many participants would be alive and not the actual number of alive participants. All-Cause Mortality data is provided in the Adverse Events Section.

Outcome measures

Measure	Group 1 - Ravulizumab + BSC n=135 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=66 Participants Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90 Day 60	60 Participants	29 Participants
Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90 Day 90	49 Participants	20 Participants

SECONDARY outcome

Timeframe: Day 1 and Day 29

Population: Pharmacokinetics/Pharmacodynamics (PK/PD) Population: participants in the ITT population with at least 1 postdose PK or PD result.

Results are reported in micrograms/milliliter (μg/mL).

Outcome measures

Measure	Group 1 - Ravulizumab + BSC n=126 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29 Day 1 (predose)	0.00 μg/mL Standard Deviation 0.00	—
Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29 Day 29 (predose)	231.35 μg/mL Standard Deviation 149.741	—

SECONDARY outcome

Timeframe: Baseline, Day 29

Population: PK/PD Population: participants in the ITT population with at least 1 postdose PK or PD result. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Measure	Group 1 - Ravulizumab + BSC n=43 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=14 Participants Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29	-156.31 μg/mL Standard Deviation 61.599	21.79 μg/mL Standard Deviation 67.918

SECONDARY outcome

Timeframe: Baseline, Day 29

Population: PK/PD Population: participants in the ITT population with at least 1 postdose PK or PD result. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

Outcome measures

Measure	Group 1 - Ravulizumab + BSC n=43 Participants Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=14 Participants Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Change From Baseline In Terminal Complement Complex C5b-9 At Day 29	-133.23 ug/L Standard Deviation 202.070	-277.21 ug/L Standard Deviation 604.742

Adverse Events

Group 1 - Ravulizumab + BSC

Serious events: 79 serious events

Other events: 97 other events

Deaths: 55 deaths

Group 2 - BSC Alone

Serious events: 38 serious events

Other events: 49 other events

Deaths: 25 deaths

Serious adverse events

Measure	Group 1 - Ravulizumab + BSC n=127 participants at risk Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=67 participants at risk Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Blood and lymphatic system disorders Thrombocytopenia	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Blood and lymphatic system disorders Anaemia	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Blood and lymphatic system disorders Haemolytic anaemia	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Blood and lymphatic system disorders Microangiopathic haemolytic anaemia	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Cardiac arrest	3.1% 4/127 • Number of events 4 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	3.0% 2/67 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Atrial fibrillation	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	3.0% 2/67 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Cardio-respiratory arrest	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	3.0% 2/67 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Pulseless electrical activity	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Ventricular tachycardia	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Acute myocardial infarction	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Atrial flutter	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Cardiac failure	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Cardiogenic shock	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Endocrine disorders Hypothyroidism	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Gastrointestinal disorders Gastric haemorrhage	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Gastrointestinal disorders Gastrointestinal ischaemia	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Gastrointestinal disorders Oesophageal haemorrhage	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
General disorders Multiple organ dysfunction syndrome	11.0% 14/127 • Number of events 14 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	9.0% 6/67 • Number of events 6 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
General disorders Condition aggravated	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
General disorders Oedema peripheral	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
General disorders Pyrexia	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Hepatobiliary disorders Ischaemic hepatitis	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Hepatobiliary disorders Hepatic failure	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Hepatobiliary disorders Liver injury	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Septic shock	10.2% 13/127 • Number of events 15 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	4.5% 3/67 • Number of events 5 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations COVID-19 pneumonia	5.5% 7/127 • Number of events 7 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Pneumonia	3.1% 4/127 • Number of events 4 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Bacteraemia	1.6% 2/127 • Number of events 3 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Sepsis	2.4% 3/127 • Number of events 3 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Pneumonia bacterial	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Staphylococcal bacteraemia	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Systemic candida	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Pneumonia pseudomonal	0.79% 1/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Bronchopulmonary aspergillosis	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations COVID-19	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Candida infection	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Clostridium difficile infection	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Cryptococcosis	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Cytomegalovirus viraemia	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Device related infection	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Enterobacter pneumonia	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Escherichia bacteraemia	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Fungal sepsis	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Herpes simplex pneumonia	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Klebsiella bacteraemia	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Pneumonia pneumococcal	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Pneumonia staphylococcal	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Pseudomonal sepsis	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Injury, poisoning and procedural complications Head injury	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Injury, poisoning and procedural complications Procedural hypotension	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Investigations Blood beta-D-glucan positive	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Investigations Blood lactic acid increased	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Investigations Fibrin D dimer increased	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Investigations Oxygen saturation decreased	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Investigations Transaminases increased	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Metabolism and nutrition disorders Metabolic acidosis	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Musculoskeletal and connective tissue disorders Haematoma muscle	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Nervous system disorders Cerebral infarction	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Nervous system disorders Brain injury	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Nervous system disorders Cerebrovascular accident	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Nervous system disorders Encephalopathy	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Nervous system disorders Haemorrhage intracranial	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Nervous system disorders Intensive care unit acquired weakness	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Renal and urinary disorders Acute kidney injury	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	3.0% 2/67 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Renal and urinary disorders Renal failure	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	3.0% 2/67 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	9.4% 12/127 • Number of events 12 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	7.5% 5/67 • Number of events 5 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	4.7% 6/127 • Number of events 6 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	6.0% 4/67 • Number of events 4 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.9% 5/127 • Number of events 5 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	7.5% 5/67 • Number of events 5 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Hypoxia	3.1% 4/127 • Number of events 4 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	4.5% 3/67 • Number of events 3 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.1% 4/127 • Number of events 5 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	3.0% 2/67 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Lung disorder	2.4% 3/127 • Number of events 3 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 2/127 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Haemothorax	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Organizing pneumonia	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Stridor	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Vascular disorders Hypotension	2.4% 3/127 • Number of events 4 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	0.00% 0/67 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Vascular disorders Shock hemorrhagic	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/127 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	1.5% 1/67 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).

Other adverse events

Measure	Group 1 - Ravulizumab + BSC n=127 participants at risk Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.	Group 2 - BSC Alone n=67 participants at risk Participants received medications, therapies, and interventions per standard hospital treatment protocols.
Vascular disorders Hypotension	12.6% 16/127 • Number of events 18 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	11.9% 8/67 • Number of events 10 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Blood and lymphatic system disorders Anaemia	10.2% 13/127 • Number of events 15 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	6.0% 4/67 • Number of events 5 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Atrial fibrillation	9.4% 12/127 • Number of events 12 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	7.5% 5/67 • Number of events 5 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
General disorders Pyrexia	7.9% 10/127 • Number of events 12 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	9.0% 6/67 • Number of events 6 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Vascular disorders Deep vein thrombosis	11.0% 14/127 • Number of events 14 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	3.0% 2/67 • Number of events 2 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Renal and urinary disorders Acute kidney injury	7.1% 9/127 • Number of events 10 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	7.5% 5/67 • Number of events 5 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Metabolism and nutrition disorders Hyperkalaemia	6.3% 8/127 • Number of events 9 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	9.0% 6/67 • Number of events 6 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Metabolism and nutrition disorders Hypernatraemia	8.7% 11/127 • Number of events 11 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	4.5% 3/67 • Number of events 3 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Skin and subcutaneous tissue disorders Decubitus ulcer	6.3% 8/127 • Number of events 9 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	6.0% 4/67 • Number of events 4 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Vascular disorders Hypertension	7.1% 9/127 • Number of events 9 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	4.5% 3/67 • Number of events 3 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Infections and infestations Pneumonia bacterial	5.5% 7/127 • Number of events 7 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	6.0% 4/67 • Number of events 4 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Gastrointestinal disorders Constipation	3.9% 5/127 • Number of events 5 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	7.5% 5/67 • Number of events 6 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Cardiac disorders Bradycardia	4.7% 6/127 • Number of events 6 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	6.0% 4/67 • Number of events 4 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.79% 1/127 • Number of events 1 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).	6.0% 4/67 • Number of events 6 • Day 1 through Day 90 Data for All-Cause Mortality was collected for the ITT Population (all randomized participants; participants were analyzed as randomized). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study drug; participants were analyzed as treated).

Additional Information

Alexion Pharmaceuticals, Inc.

Alexion Pharmaceuticals, Inc.

Phone: +1 855-752-2356

Email: clinicaltrials@alexion.com

Results disclosure agreements

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