Trial Outcomes & Findings for Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial (NCT NCT02175225)

NCT ID: NCT02175225

Last Updated: 2019-05-30

Results Overview

The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 294 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2019-05-30

Participant Flow

Participant milestones

Measure	Deferoxamine Mesylate Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Overall Study STARTED	145	149
Overall Study Initiated Study Drug	144	147
Overall Study 90 Day Outcome Obtained	140	143
Overall Study 180 Day Outcome Obtained	135	135
Overall Study COMPLETED	137	138
Overall Study NOT COMPLETED	8	11

Reasons for withdrawal

Measure	Deferoxamine Mesylate Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	6	7
Overall Study Study drug not administered	1	2

Baseline Characteristics

Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

Baseline characteristics by cohort

Measure	Deferoxamine Mesylate n=144 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=147 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)	Total n=291 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	62 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	56 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	91 Participants n=7 Participants	179 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants n=5 Participants	120 Participants n=7 Participants	243 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	25 Participants n=5 Participants	12 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) White	81 Participants n=5 Participants	100 Participants n=7 Participants	181 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Medical history: Hypertension	113 Participants n=5 Participants	124 Participants n=7 Participants	237 Participants n=5 Participants
Medical history: Diabetes mellitus	32 Participants n=5 Participants	43 Participants n=7 Participants	75 Participants n=5 Participants
Medical history: Cardiac disease	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Medical history: Pulmonary disease	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Medical history: Previous ischemic stroke or transient ischemic attack	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Medical history: Previous intracerebral hemorrhage	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Location of intracerebral hemorrhage Lobar	26 Participants n=5 Participants	33 Participants n=7 Participants	59 Participants n=5 Participants
Location of intracerebral hemorrhage Deep (thalamic)	45 Participants n=5 Participants	61 Participants n=7 Participants	106 Participants n=5 Participants
Location of intracerebral hemorrhage Deep (non-thalamic)	73 Participants n=5 Participants	53 Participants n=7 Participants	126 Participants n=5 Participants
Intraventricular hemorrhage present	47 Participants n=5 Participants	62 Participants n=7 Participants	109 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.

The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.

Outcome measures

Measure	Deferoxamine Mesylate n=140 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=143 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days	48 Participants	47 Participants

PRIMARY outcome

Timeframe: 90 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.

Number of subjects experiencing Serious adverse events at any time from randomization through day 90

Outcome measures

Measure	Deferoxamine Mesylate n=144 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=147 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Number of Subjects Experiencing Serious Adverse Events	39 Participants	49 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.

Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization

Outcome measures

Measure	Deferoxamine Mesylate n=144 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=147 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Number of Subjects With Serious Adverse Events Within 7 Days	24 Participants	26 Participants

SECONDARY outcome

Timeframe: 90 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.

Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.

Although mRS 0-3 is less favorable than the primary outcome of mRS 0-2, it would still be a desirable effect in patients with ICH given that no treatments exist to reduce disability.

Outcome measures

Measure	Deferoxamine Mesylate n=140 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=143 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Proportion of Patients With mRS Score 0-3 at 90 Days	91 Participants	82 Participants

SECONDARY outcome

Timeframe: 180 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.

Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.

Outcome measures

Measure	Deferoxamine Mesylate n=135 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=135 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days	61 Participants	48 Participants

SECONDARY outcome

Timeframe: 180 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.

Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.

Outcome measures

Measure	Deferoxamine Mesylate n=135 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=135 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days	97 Participants	92 Participants

SECONDARY outcome

Timeframe: 90 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach. Subgroup analysis by Onset to treatment time window (\<=12 hours vs \>12 hours)

Analyses will be expanded to include an interaction between treatment and OTT window and the magnitude of the treatment effect, and corresponding confidence interval, will be estimated for each time window (<12 hours vs. >/= 12 hours) in order to explore the presence of a differential treatment effect in the OTT windows.

Outcome measures

Measure	Deferoxamine Mesylate n=140 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=143 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows Onset to treatment time >12 hours	33 Participants	28 Participants
Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows Onset to treatment time <=12 hours	15 Participants	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.

The overall ordinal distribution of scores on mRS at 90 days in DFO- and placebo-treated subjects will be determined.

Outcome measures

Measure	Deferoxamine Mesylate n=140 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=143 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Ordinal Distribution of Scores on mRS at Day 90 mRS 0	6 Participants	4 Participants
Ordinal Distribution of Scores on mRS at Day 90 mRS 1	13 Participants	12 Participants
Ordinal Distribution of Scores on mRS at Day 90 mRS 2	29 Participants	31 Participants
Ordinal Distribution of Scores on mRS at Day 90 mRS 3	43 Participants	35 Participants
Ordinal Distribution of Scores on mRS at Day 90 mRS 4	33 Participants	43 Participants
Ordinal Distribution of Scores on mRS at Day 90 mRS 5	6 Participants	7 Participants
Ordinal Distribution of Scores on mRS at Day 90 mRS 6	10 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.

The overall ordinal distribution of scores on mRS at 180 days in DFO- and placebo-treated subjects will be determined.

Outcome measures

Measure	Deferoxamine Mesylate n=135 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=135 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Ordinal Distribution of Scores on mRS at 180 Days mRS 0	10 Participants	5 Participants
Ordinal Distribution of Scores on mRS at 180 Days mRS 1	18 Participants	16 Participants
Ordinal Distribution of Scores on mRS at 180 Days mRS 2	33 Participants	27 Participants
Ordinal Distribution of Scores on mRS at 180 Days mRS 3	36 Participants	44 Participants
Ordinal Distribution of Scores on mRS at 180 Days mRS 4	22 Participants	24 Participants
Ordinal Distribution of Scores on mRS at 180 Days mRS 5	4 Participants	7 Participants
Ordinal Distribution of Scores on mRS at 180 Days mRS 6	12 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during the study infusion

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.

Adverse event of special interest: anaphylaxis at any time during the study infusion

Outcome measures

Measure	Deferoxamine Mesylate n=144 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=147 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug)	3 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during the study infusion

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.

Hypotension requiring medical intervention at any time during the study infusion that could not be explained by other causes

Outcome measures

Measure	Deferoxamine Mesylate n=144 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=147 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Adverse Event of Special Interest: Number of Patients With Hypotension	1 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: after initiation of study infusion

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.

Adverse event of special interest: development of new and unexplained visual or auditory changes after initiation of the study infusion

Outcome measures

Measure	Deferoxamine Mesylate n=144 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=147 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes	3 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.

Adverse event of special interest: Respiratory compromise of any cause, including acute respiratory distress syndrome, in hospital until day 7 or discharge [whichever was earlier]

Outcome measures

Measure	Deferoxamine Mesylate n=144 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=147 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Adverse Event of Special Interest: Number of Patients With Respiratory Compromise All cause	20 Participants	23 Participants
Adverse Event of Special Interest: Number of Patients With Respiratory Compromise Cause by acute respiratory distress syndrome	2 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Population: Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.

Edema accompanied by an unexplained increase of more than four points on the US National Institutes of Health Stroke Scale or a decrease of more than two points in Glasgow Coma Scale score during the first week after the intracerebral haemorrhage.

Outcome measures

Measure	Deferoxamine Mesylate n=144 Participants Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=147 Participants Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Number of Patients With Symptomatic Cerebral Edema	9 Participants	5 Participants

Adverse Events

Deferoxamine Mesylate

Serious events: 39 serious events

Other events: 107 other events

Deaths: 12 deaths

Normal Saline

Serious events: 50 serious events

Other events: 114 other events

Deaths: 12 deaths

Serious adverse events

Measure	Deferoxamine Mesylate n=144 participants at risk Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=147 participants at risk Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Investigations Anaemia	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Cardiac disorders Arrhythmia	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Cardiac disorders Cardiac arrest	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Cardiac disorders Myocardial infarction	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Constipation	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Haematemesis	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Ileus	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Oedema mouth	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Vomiting	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Chest pain	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Systemic inflammatory response syndrome	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Immune system disorders Hypersensitivity	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Bacteraemia	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Clostridium difficile colitis	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Pneumonia	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Sepsis	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Septic shock	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Tracheobronchitis	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Urinary tract infection	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.0% 3/147 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Injury, poisoning and procedural complications Fall	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Injury, poisoning and procedural complications Wound decomposition	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Cardiac enzymes increased	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hyponatraemia	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Metabolism and nutrition disorders Dehydration	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Autonomic nervous system imbalance	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Brain herniation	2.8% 4/144 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Brain midline shift	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Brain oedema	3.5% 5/144 • Number of events 5 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders CNS ventriculitis	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Cerebral haemorrhage	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Cerebral hematoma expansion	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Convulsion	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Hydrocephalus	2.8% 4/144 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Hypoaesthesia	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Intracranial pressure increased	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Ischaemic stroke	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Neurological decompensation	0.69% 1/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Syncope/Presyncope	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Psychiatric disorders Mental status changes	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Haematuria	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Renal failure acute	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Reproductive system and breast disorders Pelvic pain	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Asthma	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.8% 4/144 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.8% 4/144 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 2/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Skin and subcutaneous tissue disorders Skin ulcer	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Surgical and medical procedures Withdrawal of life support	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Vascular disorders Deep vein thrombosis	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.0% 3/147 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Vascular disorders Hypertension	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Vascular disorders Hypotension	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.

Other adverse events

Measure	Deferoxamine Mesylate n=144 participants at risk Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate	Normal Saline n=147 participants at risk Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate)
Gastrointestinal disorders Abdominal pain	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Anorectal disorder	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Constipation	4.2% 6/144 • Number of events 6 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	6.8% 10/147 • Number of events 10 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Diarrhoea	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.0% 3/147 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Dry mouth	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Dysphagia	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Ileus	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Lip swelling	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Nausea	3.5% 5/144 • Number of events 5 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.0% 3/147 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Reflux gastritis	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Swollen tongue	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Vomiting	9.0% 13/144 • Number of events 13 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	4.1% 6/147 • Number of events 6 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Chest pain	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Discomfort	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Fatigue	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Inflammation	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Infusion site extravasation	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	3.4% 5/147 • Number of events 6 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Infusion site pain	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Injection site irritation	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Injection site reaction	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Nodule	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Oedema	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Metabolism and nutrition disorders Diabetes mellitus	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Oedema peripheral	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Pain	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Pyrexia	11.8% 17/144 • Number of events 17 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	10.9% 16/147 • Number of events 17 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
General disorders Systemic inflammatory response syndrome	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Bacteraemia	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Cellulitis	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Metabolism and nutrition disorders Fluid retention	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Otitis media	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Pneumonia	4.9% 7/144 • Number of events 7 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.0% 3/147 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Sinusitis	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Skin candida	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Cerebral hematoma expansion	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.0% 3/147 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Tinea pedis	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Tracheobronchitis	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Infections and infestations Urinary tract infection	12.5% 18/144 • Number of events 18 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	15.0% 22/147 • Number of events 22 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Injury, poisoning and procedural complications Anaphylactic transfusion reaction	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Injury, poisoning and procedural complications Fall	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Activated partial thromboplastin time prolonged	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Anaemia	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Blood creatinine increased	2.8% 4/144 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	4.1% 6/147 • Number of events 6 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Blood glucose increased	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Blood potassium decreased	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Blood urea increased	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Cardiac enzymes increased	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Coagulopathy	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hepatic enzyme increased	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hyperglycaemia	4.9% 7/144 • Number of events 7 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	4.8% 7/147 • Number of events 7 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hypernatraemia	3.5% 5/144 • Number of events 5 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hyperphosphataemia	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hypoalbuminaemia	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hypocalcaemia	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.0% 3/147 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hypokalaemia	7.6% 11/144 • Number of events 11 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hypomagnesaemia	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hyponatraemia	3.5% 5/144 • Number of events 5 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	3.4% 5/147 • Number of events 5 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Hypophosphataemia	4.9% 7/144 • Number of events 7 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations International normalised ratio increased	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Laboratory test abnormal	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Leukocytosis	3.5% 5/144 • Number of events 5 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	3.4% 5/147 • Number of events 5 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Monocyte count	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Prothrombin time prolonged	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Pyuria	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Rubulavirus test positive	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Thrombocytopenia	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Investigations Urine output decreased	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Metabolism and nutrition disorders Dehydration	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Metabolism and nutrition disorders Gout	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Arthralgia	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Joint effusion	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Joint swelling	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Muscle spasms	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Pain in extremity	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Brain midline shift	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Brain oedema	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Cerebral haemorrhage	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Convulsion	2.8% 4/144 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	4.1% 6/147 • Number of events 6 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Encephalopathy	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Headache	4.9% 7/144 • Number of events 7 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	5.4% 8/147 • Number of events 8 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Hemiparesis	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Hemiplegia	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Hydrocephalus	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	3.4% 5/147 • Number of events 5 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Intracranial aneurysm	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Intracranial pressure increased	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.0% 3/147 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Ischaemic stroke	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Lethargy	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Neurological decompensation	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Paraesthesia	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Sensory loss	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Somnolence	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 5 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Syncope/Presyncope	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Tremor	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Nervous system disorders Visual field defect	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.0% 3/147 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Psychiatric disorders Agitation	9.0% 13/144 • Number of events 15 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	5.4% 8/147 • Number of events 9 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Psychiatric disorders Alcohol withdrawal syndrome	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Psychiatric disorders Anxiety	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Psychiatric disorders Confusional state	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Psychiatric disorders Delirium	4.9% 7/144 • Number of events 7 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	3.4% 5/147 • Number of events 5 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Psychiatric disorders Depression	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Psychiatric disorders Insomnia	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Dysuria	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Haematuria	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Incontinence	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Nephropathy	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Renal failure acute	4.2% 6/144 • Number of events 6 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	6.1% 9/147 • Number of events 9 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Renal failure chronic	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Urinary incontinence	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Renal and urinary disorders Urinary retention	5.6% 8/144 • Number of events 8 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	4.8% 7/147 • Number of events 7 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Reproductive system and breast disorders Breast mass	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Aspiration	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	4.1% 6/147 • Number of events 6 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Skin and subcutaneous tissue disorders Pruritus	2.1% 3/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Skin and subcutaneous tissue disorders Rash	1.4% 2/144 • Number of events 3 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Vascular disorders Deep vein thrombosis	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Vascular disorders Haematoma	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Vascular disorders Hypertension	1.4% 2/144 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	2.7% 4/147 • Number of events 4 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Vascular disorders Hypotension	4.2% 6/144 • Number of events 6 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	4.1% 6/147 • Number of events 7 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Vascular disorders Neurogenic shock	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Vascular disorders Thrombophlebitis superficial	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Eye disorders Blindness	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Cardiac disorders Arrhythmia	7.6% 11/144 • Number of events 12 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	7.5% 11/147 • Number of events 13 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Cardiac disorders Myocardial infarction	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Cardiac disorders Myocardial ischaemia	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Ear and labyrinth disorders Ear pain	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Ear and labyrinth disorders Hearing impaired	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Ear and labyrinth disorders Tinnitus	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Endocrine disorders Goitre	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Eye disorders Colour blindness	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Eye disorders Conjunctivitis	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Eye disorders Diplopia	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Eye disorders Eye pain	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Eye disorders Gaze palsy	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Eye disorders Pupils unequal	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	1.4% 2/147 • Number of events 2 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Eye disorders Scleral oedema	0.00% 0/144 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.68% 1/147 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Gastrointestinal disorders Abdominal distension	0.69% 1/144 • Number of events 1 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.	0.00% 0/147 • All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier. Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.

Additional Information

Magdy Selim, MD, PhD

Beth Israel Deaconess Medical Center

Phone: 617-632-8913

Email: mselim@bidmc.harvard.edu

Results disclosure agreements

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