Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion (NCT NCT03954041)

NCT ID: NCT03954041

Last Updated: 2024-11-27

Results Overview

Total contusion volume including hematoma and perihematomal edema volumes reported in milliliters (mL) was assessed by the central imaging core laboratory on baseline non-contrast computed tomography (NCCT), 24-hour NCCT, and the 96-hour scan (Magnetic resonance imaging \[MRI\] and/or NCCT) and the scans obtained prior to decompressive craniectomy (DC), intraparenchymal hematoma (IPH) evacuation, or comfort measures only (CMO).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 92 participants
• Primary outcome timeframe: Baseline up to 96 hours (Day 4)
• Results posted on: 2024-11-27

Participant Flow

Participants were enrolled at study centers in Israel, France, Japan, Italy, Spain, and the United States.

A total of 92 participants were enrolled and randomized, out of which 86 participants were dosed with BIIB093 or a matching placebo.

Participant milestones

Measure	Placebo Participants were administered with BIIB093 matching placebo as an intravenous (IV) bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day Participants were administered with BIIB093 up to 3 milligrams per day (mg/day) as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Overall Study STARTED	48	23	21
Overall Study COMPLETED	30	14	11
Overall Study NOT COMPLETED	18	9	10

Reasons for withdrawal

Measure	Placebo Participants were administered with BIIB093 matching placebo as an intravenous (IV) bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day Participants were administered with BIIB093 up to 3 milligrams per day (mg/day) as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Overall Study Lost to Follow-up	3	3	6
Overall Study Death	4	0	1
Overall Study Death by neurologic criteria	0	0	1
Overall Study Reason not specified	7	4	2
Overall Study Withdrew prior to dosing	4	2	0

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion

Baseline characteristics by cohort

Measure	Placebo n=44 Participants Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day n=21 Participants Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day n=21 Participants Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	Total n=86 Participants Total of all reporting groups
Age, Continuous	59.3 years STANDARD_DEVIATION 14.18 • n=5 Participants	55.7 years STANDARD_DEVIATION 19.87 • n=7 Participants	55.0 years STANDARD_DEVIATION 21.02 • n=5 Participants	57.4 years STANDARD_DEVIATION 17.39 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	72 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	68 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	12 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	26 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	51 Participants n=4 Participants
Race/Ethnicity, Customized Race · Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to 96 hours (Day 4)

Population: mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.

Total contusion volume including hematoma and perihematomal edema volumes reported in milliliters (mL) was assessed by the central imaging core laboratory on baseline non-contrast computed tomography (NCCT), 24-hour NCCT, and the 96-hour scan (Magnetic resonance imaging [MRI] and/or NCCT) and the scans obtained prior to decompressive craniectomy (DC), intraparenchymal hematoma (IPH) evacuation, or comfort measures only (CMO).

Outcome measures

Measure	Placebo n=38 Participants Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day n=20 Participants Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day n=19 Participants Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging Baseline	29.45 mL Standard Deviation 29.688	21.21 mL Standard Deviation 26.659	21.33 mL Standard Deviation 26.637
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging Change From Baseline at 96 Hours	18.91 mL Standard Deviation 23.804	30.07 mL Standard Deviation 29.418	18.78 mL Standard Deviation 12.771

SECONDARY outcome

Timeframe: Day 180

Population: mITT population included all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.

The GOS-E is a global disability scale used to assess recovery after traumatic brain injury. For this study, the 8 point ordinal scale was condensed to the following 7-categories: 1 and 2 combined: Dead and Vegetative State, 3: Lower Severe disability, 4: Upper Severe disability, 5: Lower Moderate disability, 6: Upper Moderate disability, 7 : Lower Good recovery, and 8: Upper Good Recovery. Lower scores indicate death and higher scores indicate recovery.

Outcome measures

Measure	Placebo n=30 Participants Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day n=15 Participants Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day n=11 Participants Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 Score: 1/2	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 Score: 3	13.3 Percentage of participants	13.3 Percentage of participants	27.3 Percentage of participants
Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 Score: 4	0 Percentage of participants	26.7 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 Score: 5	13.3 Percentage of participants	6.7 Percentage of participants	0 Percentage of participants
Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 Score: 6	26.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 Score: 7	6.7 Percentage of participants	13.3 Percentage of participants	27.3 Percentage of participants
Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 Score: 8	40.0 Percentage of participants	40.0 Percentage of participants	36.4 Percentage of participants

SECONDARY outcome

Timeframe: Day 90

Population: mITT population included all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit or NSx or CMO, if earlier. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.

The mRS measures the degree of functional independence following stroke. In this study, the 7-category ordinal mRS scale was condensed to the following 5-categories: 0/1, 2, 3, 4, 5/6 where 0 and 1 reflect no disability and near-normal functioning while 5 and 6 represent severe disability and death, respectively.

Outcome measures

Measure	Placebo n=39 Participants Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day n=19 Participants Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day n=14 Participants Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 Score: 0/1	38.5 Percentage of participants	31.6 Percentage of participants	57.1 Percentage of participants
Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 Score: 2	25.6 Percentage of participants	26.3 Percentage of participants	7.1 Percentage of participants
Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 Score: 3	12.8 Percentage of participants	21.1 Percentage of participants	0 Percentage of participants
Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 Score: 4	10.3 Percentage of participants	15.8 Percentage of participants	21.4 Percentage of participants
Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 Score: 5/6	12.8 Percentage of participants	5.3 Percentage of participants	14.3 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 (24 hours) up to Day 4 (96 hours) post-injury

Population: mITT population included all the randomized participants who received any study drug (BIIB093 or placebo) and had at least one final read per central review of contusion volume from a NCCT or MRI scan acquired between 10 hours after the initiation of study drug infusion and the Hour 96 visit or NSx or CMO, if earlier.

Delayed intubation is defined as participants requiring intubation (for neurologic deterioration only) at any time between 24 hours and 96 hours post-injury.

Outcome measures

Measure	Placebo n=44 Participants Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day n=21 Participants Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day n=20 Participants Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Percentage of Participants Requiring Delayed Intubation	2.3 Percentage of participants	4.8 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 24 hours (Day 1)

Population: mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.

Total contusion volume including hematoma and perihematomal edema volumes reported in mL was assessed by the central imaging core laboratory on baseline NCCT and 24-hour NCCT.

Outcome measures

Measure	Placebo n=38 Participants Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day n=20 Participants Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day n=19 Participants Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging Baseline	29.45 mL Standard Deviation 29.688	21.21 mL Standard Deviation 26.659	21.33 mL Standard Deviation 26.637
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging Change From Baseline at 24 Hours	8.16 mL Standard Deviation 18.824	11.24 mL Standard Deviation 13.909	6.67 mL Standard Deviation 13.483

SECONDARY outcome

Timeframe: Baseline up to 24 hours (Day 1)

Population: mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.

Hematoma volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the scans obtained prior to DC, IPH evacuation, or CMO.

Outcome measures

Measure	Placebo n=40 Participants Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day n=20 Participants Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day n=20 Participants Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Change From Baseline in Absolute Hematoma Volume at 24 Hours Baseline	6.72 mL Standard Deviation 10.012	6.11 mL Standard Deviation 12.086	3.62 mL Standard Deviation 3.737
Change From Baseline in Absolute Hematoma Volume at 24 Hours Change From Baseline at 24 Hours	2.07 mL Standard Deviation 5.920	2.13 mL Standard Deviation 3.667	2.23 mL Standard Deviation 3.537

SECONDARY outcome

Timeframe: Baseline up to 96 hours (Day 4)

Population: mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.

Edema volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the 96-hour scan (MRI and/or NCCT) and the scans obtained prior to DC, IPH evacuation, or CMO.

Outcome measures

Measure	Placebo n=38 Participants Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day n=20 Participants Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day n=19 Participants Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Change From Baseline in Absolute Edema Volume at 96 Hours Change From Baseline at 96 Hours	16.13 mL Standard Deviation 20.872	25.87 mL Standard Deviation 27.772	14.98 mL Standard Deviation 10.459
Change From Baseline in Absolute Edema Volume at 96 Hours Baseline	22.41 mL Standard Deviation 23.234	15.10 mL Standard Deviation 16.366	17.52 mL Standard Deviation 24.103

SECONDARY outcome

Timeframe: Randomization up to Day 90

Population: mITT population included all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT or MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit or NSx or CMO, if earlier. 'Overall number of participants analyzed' signifies the number of participants who died from randomization up to Day 90.

Time to all-cause death is defined as the time from randomization to the time of death and includes all-cause death along with neurological death.

Outcome measures

Measure	Placebo n=3 Participants Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3 mg/Day Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5 mg/Day n=1 Participants Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Time to All-Cause Death Through Day 90	NA days Not estimable due to the small number of deaths.	—	NA days Not estimable due to the small number of deaths.

Adverse Events

Placebo

Serious events: 12 serious events

Other events: 36 other events

Deaths: 4 deaths

BIIB093 3mg/Day

Serious events: 7 serious events

Other events: 20 other events

Deaths: 0 deaths

BIIB093 5mg/Day

Serious events: 8 serious events

Other events: 18 other events

Deaths: 2 deaths

Serious adverse events

Measure	Placebo n=44 participants at risk Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3mg/Day n=23 participants at risk Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5mg/Day n=19 participants at risk Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Cardiac disorders Cardiac arrest	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Cardiac disorders Cardio-respiratory arrest	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Gastrointestinal disorders Rectal haemorrhage	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
General disorders Multiple organ dysfunction syndrome	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Hepatobiliary disorders Cholecystitis	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Appendicitis	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Klebsiella sepsis	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Pneumonia	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Pneumonia staphylococcal	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Postoperative wound infection	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Urosepsis	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Injury, poisoning and procedural complications Brain contusion	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Injury, poisoning and procedural complications Fall	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Injury, poisoning and procedural complications Femoral neck fracture	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Injury, poisoning and procedural complications Radius fracture	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Injury, poisoning and procedural complications Subdural haematoma	4.5% 2/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	17.4% 4/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	21.1% 4/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Brain oedema	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Cerebral haemorrhage	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Epilepsy	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Intracranial pressure increased	4.5% 2/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	15.8% 3/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Neurological decompensation	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Posterior reversible encephalopathy syndrome	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Psychiatric disorders Korsakoff's syndrome	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Psychiatric disorders Restlessness	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Vascular disorders Hypotension	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).

Other adverse events

Measure	Placebo n=44 participants at risk Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 3mg/Day n=23 participants at risk Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.	BIIB093 5mg/Day n=19 participants at risk Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days.
Musculoskeletal and connective tissue disorders Back pain	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Musculoskeletal and connective tissue disorders Pain in extremity	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Altered state of consciousness	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Anosmia	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Aphasia	4.5% 2/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Cognitive disorder	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Dementia with lewy bodies	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Dizziness	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	10.5% 2/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Epilepsy	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Generalised tonic-clonic seizure	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Headache	15.9% 7/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	17.4% 4/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	10.5% 2/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Intracranial pressure increased	11.4% 5/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Lacunar infarction	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Lateral medullary syndrome	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Blood and lymphatic system disorders Anaemia	11.4% 5/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	10.5% 2/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Blood and lymphatic system disorders Dilutional anaemia	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Cardiac disorders Atrial fibrillation	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Cardiac disorders Bradycardia	11.4% 5/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	17.4% 4/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	10.5% 2/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Cardiac disorders Supraventricular tachycardia	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Cardiac disorders Tachycardia	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Ear and labyrinth disorders Vertigo	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Eye disorders Anisocoria	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Eye disorders Vision blurred	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Gastrointestinal disorders Constipation	22.7% 10/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	26.1% 6/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	10.5% 2/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Gastrointestinal disorders Diarrhoea	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	13.0% 3/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Gastrointestinal disorders Dysphagia	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Gastrointestinal disorders Nausea	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	15.8% 3/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Gastrointestinal disorders Proctitis haemorrhagic	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Gastrointestinal disorders Salivary hypersecretion	9.1% 4/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Gastrointestinal disorders Vomiting	9.1% 4/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	21.7% 5/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
General disorders Asthenia	4.5% 2/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
General disorders Generalised oedema	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
General disorders Hypothermia	9.1% 4/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
General disorders Medical device site erosion	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
General disorders Oedema peripheral	4.5% 2/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
General disorders Pyrexia	20.5% 9/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	26.1% 6/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	15.8% 3/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Hepatobiliary disorders Cholestasis	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Hepatobiliary disorders Hepatic cytolysis	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Hepatobiliary disorders Hepatic function abnormal	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	13.0% 3/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Covid-19	4.5% 2/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Diverticulitis intestinal haemorrhagic	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Escherichia infection	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Pneumonia	20.5% 9/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	13.0% 3/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	15.8% 3/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Pneumonia aspiration	4.5% 2/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Tracheobronchitis	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Infections and infestations Urinary tract infection	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Injury, poisoning and procedural complications Brain contusion	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Investigations C-reactive protein increased	13.6% 6/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Investigations Electroencephalogram abnormal	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Investigations Fibrin d dimer increased	9.1% 4/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Investigations Gamma-glutamyltransferase increased	11.4% 5/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Investigations Haemoglobin decreased	4.5% 2/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Metabolism and nutrition disorders Hyperchloraemia	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Metabolism and nutrition disorders Hyperglycaemia	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	10.5% 2/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Metabolism and nutrition disorders Hypernatraemia	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Metabolism and nutrition disorders Hypocalcaemia	9.1% 4/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Metabolism and nutrition disorders Hypoglycaemia	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	30.4% 7/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	15.8% 3/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Metabolism and nutrition disorders Hypokalaemia	22.7% 10/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	26.1% 6/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	10.5% 2/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Metabolism and nutrition disorders Hyponatraemia	13.6% 6/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	26.1% 6/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Musculoskeletal and connective tissue disorders Arthralgia	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Memory impairment	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Neurological decompensation	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Sciatica	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Seizure	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Subdural hygroma	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Nervous system disorders Syncope	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Psychiatric disorders Agitation	13.6% 6/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	15.8% 3/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Psychiatric disorders Confusional state	4.5% 2/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Psychiatric disorders Delirium	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	15.8% 3/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Psychiatric disorders Disorientation	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Psychiatric disorders Insomnia	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	13.0% 3/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Psychiatric disorders Irritability	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Psychiatric disorders Restlessness	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Renal and urinary disorders Acute kidney injury	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Renal and urinary disorders Dysuria	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	8.7% 2/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Renal and urinary disorders Oliguria	11.4% 5/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	13.0% 3/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Renal and urinary disorders Polyuria	11.4% 5/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Reproductive system and breast disorders Priapism	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Respiratory, thoracic and mediastinal disorders Atelectasis	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.8% 3/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	2.3% 1/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	13.0% 3/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Vascular disorders Hypertension	20.5% 9/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	26.1% 6/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	21.1% 4/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Vascular disorders Hypotension	13.6% 6/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	0.00% 0/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Vascular disorders Orthostatic hypotension	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).
Vascular disorders Phlebitis	0.00% 0/44 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	4.3% 1/23 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).	5.3% 1/19 • From signing of informed consent up to last follow-up visit (approximately 1360 days) Safety analysis set included all randomized participants who had received any infusion of the study drug (BIIB093 or placebo).

Additional Information

US Biogen Clinical Trial Center

Biogen

Phone: 866-633-4636

Email: clinicaltrials@biogen.com

Results disclosure agreements

• Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
• Publication restrictions are in place

Restriction type: OTHER