Trial Outcomes & Findings for Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial) (NCT NCT06729606)

NCT ID: NCT06729606

Last Updated: 2025-10-09

Results Overview

The primary outcome was a 6-category ordinal outcome defining the participant's status at Day 90: (1) at home (defined as the type of residence before hospitalization) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalized but either on supplemental oxygen or not at home, (5) hospitalized or in hospice care, or (6) dead.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 471 participants
• Primary outcome timeframe: Status on Day 90
• Results posted on: 2025-10-09

Participant Flow

This substudy presents analysis for Aviptadil vs Aviptadil Placebo. Per protocol, this comparison was conducted among the pooled cohort of participants who were randomized to receive Active Aviptadil or Aviptadil Placebo within randomization strata 1, 2, and 4 of the master protocol.

Participant milestones

Measure	Aviptadil + SOC Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761). Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761). Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Overall Study STARTED	234	237
Overall Study COMPLETED	231	230
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Measure	Aviptadil + SOC Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761). Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761). Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Overall Study Adverse Event	0	2
Overall Study Death	1	0
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	2	4

Baseline Characteristics

Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)

Baseline characteristics by cohort

Measure	Aviptadil + SOC n=231 Participants Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=230 Participants Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Total n=461 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	156 Participants n=93 Participants	161 Participants n=4 Participants	317 Participants n=27 Participants
Age, Categorical >=65 years	75 Participants n=93 Participants	69 Participants n=4 Participants	144 Participants n=27 Participants
Age, Continuous	56.6 years STANDARD_DEVIATION 14.7 • n=93 Participants	56.2 years STANDARD_DEVIATION 15.1 • n=4 Participants	56.4 years STANDARD_DEVIATION 14.9 • n=27 Participants
Sex: Female, Male Female	94 Participants n=93 Participants	84 Participants n=4 Participants	178 Participants n=27 Participants
Sex: Female, Male Male	137 Participants n=93 Participants	146 Participants n=4 Participants	283 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	62 Participants n=93 Participants	58 Participants n=4 Participants	120 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	169 Participants n=93 Participants	172 Participants n=4 Participants	341 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized Race · Asian	7 Participants n=93 Participants	10 Participants n=4 Participants	17 Participants n=27 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Race · Black or African American	40 Participants n=93 Participants	33 Participants n=4 Participants	73 Participants n=27 Participants
Race/Ethnicity, Customized Race · White	123 Participants n=93 Participants	132 Participants n=4 Participants	255 Participants n=27 Participants
Race/Ethnicity, Customized Race · More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race · Other	16 Participants n=93 Participants	11 Participants n=4 Participants	27 Participants n=27 Participants
Race/Ethnicity, Customized Race · Only ethnicity (race unknown)	40 Participants n=93 Participants	36 Participants n=4 Participants	76 Participants n=27 Participants

PRIMARY outcome

Timeframe: Status on Day 90

Population: 6 participants in the Aviptadil+SOC arm and 5 participants in the Placebo+SOC arm did not have the day 90 status available to compute the primary endpoint. These participants were excluded from the analysis.

The primary outcome was a 6-category ordinal outcome defining the participant's status at Day 90: (1) at home (defined as the type of residence before hospitalization) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalized but either on supplemental oxygen or not at home, (5) hospitalized or in hospice care, or (6) dead.

Outcome measures

Measure	Aviptadil + SOC n=225 Participants Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=225 Participants Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 1 = at home and off oxygen (recovered) for at least 77 days	36 Participants	31 Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 2 = at home and off oxygen for 49-76 days	37 Participants	35 Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 3 = at home and off oxygen for 1-48 days	43 Participants	32 Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 4 = not hospitalized but either on supplemental oxygen or not at home	15 Participants	31 Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 5 = hospitalized or in hospice care	8 Participants	13 Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 6 = died	86 Participants	83 Participants

SECONDARY outcome

Timeframe: Through Day 90

Outcome measures

Measure	Aviptadil + SOC n=231 Participants Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=230 Participants Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Number of Participants Who Died Through Day 90	86 Participants	83 Participants

SECONDARY outcome

Timeframe: Through Day 5

Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 5

Outcome measures

Measure	Aviptadil + SOC n=231 Participants Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=230 Participants Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Number of Participants With a Safety Outcome Through Day 5	146 Participants	129 Participants

SECONDARY outcome

Timeframe: Through Day 28

Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 28

Outcome measures

Measure	Aviptadil + SOC n=231 Participants Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=230 Participants Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Number of Participants With a Safety Outcome Through Day 28	181 Participants	172 Participants

SECONDARY outcome

Timeframe: Through Day 180

Outcome measures

Measure	Aviptadil + SOC n=231 Participants Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=230 Participants Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Number of Participants Who Died Through Day 180	90 Participants	86 Participants

Adverse Events

Aviptadil + SOC

Serious events: 25 serious events

Other events: 200 other events

Deaths: 90 deaths

Placebo + SOC

Serious events: 23 serious events

Other events: 176 other events

Deaths: 86 deaths

Serious adverse events

Measure	Aviptadil + SOC n=231 participants at risk Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=230 participants at risk Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Acute myocardial infarction	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Cardiac arrest	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Palpitations	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Pulseless electrical activity	2.2% 5/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Ventricular tachycardia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Diarrhoea	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Diverticular perforation	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Large intestine perforation	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Herpes zoster	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Septic shock	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Injury, poisoning and procedural complications Barotrauma	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Injury, poisoning and procedural complications Subdural haematoma	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Investigations Computerised tomogram thorax abnormal	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Seizure	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Psychiatric disorders Delirium	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Psychiatric disorders Mental status changes	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.0% 7/231 • Number of events 8 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	3.0% 7/230 • Number of events 7 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Skin and subcutaneous tissue disorders Rash	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Hypertension	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Hypotension	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment

Other adverse events

Measure	Aviptadil + SOC n=231 participants at risk Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=230 participants at risk Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Renal and urinary disorders Haematuria	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Renal and urinary disorders Renal impairment	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Renal and urinary disorders Renal injury	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Renal and urinary disorders Renal tubular dysfunction	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Renal and urinary disorders Urinary retention	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.3% 3/231 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.7% 4/230 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.2% 5/231 • Number of events 6 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.7% 4/230 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Renal and urinary disorders Oliguria	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Bradypnoea	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Renal and urinary disorders Renal failure	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	2.6% 6/230 • Number of events 6 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Blood and lymphatic system disorders Anaemia	2.6% 6/231 • Number of events 6 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.7% 4/230 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Blood and lymphatic system disorders Blood loss anaemia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Blood and lymphatic system disorders Coagulopathy	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Blood and lymphatic system disorders Leukocytosis	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Blood and lymphatic system disorders Neutropenia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Acute myocardial infarction	1.7% 4/231 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Acute right ventricular failure	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Angina pectoris	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Arrhythmia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Arrhythmia supraventricular	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Atrial fibrillation	2.2% 5/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	5.2% 12/230 • Number of events 13 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Bradycardia	7.8% 18/231 • Number of events 21 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	9.6% 22/230 • Number of events 33 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Cardiac arrest	1.7% 4/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Cardiac failure	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Cardiac failure acute	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Cardiogenic shock	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Extrasystoles	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Myocardial infarction	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Palpitations	0.43% 1/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Pulseless electrical activity	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Right ventricular failure	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Sinus tachycardia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Supraventricular extrasystoles	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Supraventricular tachycardia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Tachycardia	10.8% 25/231 • Number of events 27 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	6.5% 15/230 • Number of events 21 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Ventricular arrhythmia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Ventricular extrasystoles	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Cardiac disorders Ventricular tachycardia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.7% 4/230 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Ear and labyrinth disorders Tinnitus	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Eye disorders Eye oedema	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Abdominal distension	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Abdominal pain	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Constipation	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.7% 4/230 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Diarrhoea	5.6% 13/231 • Number of events 14 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	2.2% 5/230 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Diverticular perforation	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Dysphagia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.7% 4/230 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Flatulence	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Gastrointestinal haemorrhage	1.7% 4/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Haematochezia	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Ileus	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Melaena	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Nausea	3.0% 7/231 • Number of events 8 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	3.0% 7/230 • Number of events 8 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Pancreatitis	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Peptic ulcer	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Rectal haemorrhage	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Retroperitoneal haematoma	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Salivary hypersecretion	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Gastrointestinal disorders Vomiting	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Chest discomfort	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Chills	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	2.6% 6/230 • Number of events 6 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Complication associated with device	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Fatigue	0.87% 2/231 • Number of events 6 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Flushing	14.7% 34/231 • Number of events 48 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	6.1% 14/230 • Number of events 20 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Hyperhidrosis	1.7% 4/231 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Hypothermia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Infusion site extravasation	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Non-cardiac chest pain	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Oedema	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Pyrexia	14.3% 33/231 • Number of events 49 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	13.5% 31/230 • Number of events 45 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
General disorders Systemic inflammatory response syndrome	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Hepatobiliary disorders Acute hepatic failure	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Hepatobiliary disorders Cholestasis	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Immune system disorders Multisystem inflammatory syndrome	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Immune system disorders Multisystem inflammatory syndrome in adults	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Immune system disorders Urticaria	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Abdominal abscess	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Bacteraemia	0.87% 2/231 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations COVID-19 pneumonia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Candida infection	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Clostridium difficile colitis	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Clostridium difficile infection	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Cytomegalovirus infection	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Cytomegalovirus infection reactivation	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Enterobacter pneumonia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Enterococcal bacteraemia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Escherichia bacteraemia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Escherichia urinary tract infection	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Fungaemia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Fungal infection	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Haemophilus bacteraemia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Helicobacter infection	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Infectious pleural effusion	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Klebsiella sepsis	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Parotitis	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Pneumonia	3.5% 8/231 • Number of events 8 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	3.0% 7/230 • Number of events 7 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Pneumonia aspiration	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Pneumonia bacterial	2.6% 6/231 • Number of events 6 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.7% 4/230 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Pneumonia haemophilus	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Pneumonia klebsiella	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Pneumonia pseudomonal	1.3% 3/231 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Pneumonia staphylococcal	2.2% 5/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	3.0% 7/230 • Number of events 7 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Respiratory tract infection fungal	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Sepsis	2.2% 5/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	2.2% 5/230 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Septic shock	5.2% 12/231 • Number of events 12 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	6.1% 14/230 • Number of events 16 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Sinusitis bacterial	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Staphylococcal bacteraemia	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.7% 4/230 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Staphylococcal infection	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Staphylococcal sepsis	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Streptococcal bacteraemia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Upper respiratory tract infection	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Urinary tract infection	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Urinary tract infection bacterial	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Urinary tract infection enterococcal	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Urinary tract infection fungal	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Urinary tract infection staphylococcal	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Infections and infestations Viral sepsis	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Injury, poisoning and procedural complications Barotrauma	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Injury, poisoning and procedural complications Post procedural hypotension	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Injury, poisoning and procedural complications Subdural haematoma	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Injury, poisoning and procedural complications Substance-induced psychotic disorder	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Injury, poisoning and procedural complications Vascular access site erythema	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Investigations Haemoglobin decreased	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Investigations Urine output decreased	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Acidosis	1.3% 3/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Decreased appetite	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Hyperglycaemia	3.0% 7/231 • Number of events 8 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Hyperkalaemia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Hypertriglyceridaemia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Hypoglycaemia	0.43% 1/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Metabolic acidosis	1.7% 4/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Metabolism and nutrition disorders Type 2 diabetes mellitus	1.7% 4/231 • Number of events 8 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Areflexia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Cerebellar stroke	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Dizziness	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Encephalopathy	2.2% 5/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.7% 4/230 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Haemorrhagic stroke	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Headache	6.1% 14/231 • Number of events 16 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	3.0% 7/230 • Number of events 11 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Intensive care unit acquired weakness	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Metabolic encephalopathy	1.7% 4/231 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Paraesthesia	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Polyneuropathy	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Presyncope	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Seizure	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Somnolence	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Syncope	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Nervous system disorders Toxic encephalopathy	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Psychiatric disorders Agitation	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Psychiatric disorders Anxiety	1.7% 4/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Psychiatric disorders Confusional state	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Psychiatric disorders Delirium	1.3% 3/231 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Psychiatric disorders Intensive care unit delirium	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Psychiatric disorders Mental status changes	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Psychiatric disorders Suicidal ideation	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Renal and urinary disorders Acute kidney injury	6.9% 16/231 • Number of events 19 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	9.6% 22/230 • Number of events 28 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Renal and urinary disorders Anuria	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Renal and urinary disorders Azotaemia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Cough	0.87% 2/231 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Dry throat	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.6% 6/231 • Number of events 6 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	3.5% 8/230 • Number of events 8 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Epistaxis	0.43% 1/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Hypoxia	6.1% 14/231 • Number of events 20 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	4.8% 11/230 • Number of events 16 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	2.2% 5/231 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.9% 9/231 • Number of events 10 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	2.2% 5/230 • Number of events 5 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Productive cough	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.6% 6/231 • Number of events 6 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	1.7% 4/231 • Number of events 6 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.2% 12/231 • Number of events 13 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	6.1% 14/230 • Number of events 14 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.87% 2/231 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Throat tightness	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	1.3% 3/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Skin and subcutaneous tissue disorders Drug eruption	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Skin and subcutaneous tissue disorders Rash	2.2% 5/231 • Number of events 8 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.87% 2/230 • Number of events 3 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Surgical and medical procedures Endotracheal intubation	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Surgical and medical procedures Haemofiltration	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Surgical and medical procedures Renal replacement therapy	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Deep vein thrombosis	4.3% 10/231 • Number of events 10 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	7.0% 16/230 • Number of events 18 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Distributive shock	0.87% 2/231 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Flushing	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Hot flush	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Hypertension	18.2% 42/231 • Number of events 61 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	16.5% 38/230 • Number of events 56 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Hypotension	68.8% 159/231 • Number of events 709 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	60.9% 140/230 • Number of events 687 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Peripheral artery thrombosis	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Peripheral ischaemia	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Shock	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	2.6% 6/230 • Number of events 12 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Shock haemorrhagic	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Thrombosis	0.00% 0/231 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.43% 1/230 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Venous thrombosis	0.43% 1/231 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/230 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment

Additional Information

Shweta Sharma Mistry

University of Minnesota

Phone: 612-626-9021

Email: shwetas@ccbr.umn.edu

Results disclosure agreements

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