Trial Outcomes & Findings for Safety Evaluation of 3K3A-APC in Ischemic Stroke (NCT NCT02222714)

NCT ID: NCT02222714

Last Updated: 2018-11-08

Results Overview

Specific AEs in the study were defined in the protocol to be dose-limiting toxicity events. Any given patient was adjudicated in a binary way to either have had a DLT or not to have had a DLT.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 110 participants
• Primary outcome timeframe: 48-hours following last dose
• Results posted on: 2018-11-08

Participant Flow

Participant milestones

Measure	120 µg/kg of 3K3A-APC 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
Overall Study STARTED	15	24	12	15	44
Overall Study COMPLETED	15	22	8	11	37
Overall Study NOT COMPLETED	0	2	4	4	7

Reasons for withdrawal

Measure	120 µg/kg of 3K3A-APC 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
Overall Study Death	0	2	3	4	6
Overall Study Withdrawal by Subject	0	0	1	0	1

Baseline Characteristics

Safety Evaluation of 3K3A-APC in Ischemic Stroke

Baseline characteristics by cohort

Measure	120 µg/kg of 3K3A-APC n=15 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=24 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC n=12 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC n=15 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo n=44 Participants Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion	Total n=110 Participants Total of all reporting groups
Age, Continuous	63.3 years n=93 Participants	61.4 years n=4 Participants	65.3 years n=27 Participants	66.2 years n=483 Participants	63.8 years n=36 Participants	63.7 years n=10 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	12 Participants n=4 Participants	6 Participants n=27 Participants	8 Participants n=483 Participants	20 Participants n=36 Participants	57 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	12 Participants n=4 Participants	6 Participants n=27 Participants	7 Participants n=483 Participants	24 Participants n=36 Participants	53 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	7 Participants n=36 Participants	11 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants	22 Participants n=4 Participants	12 Participants n=27 Participants	13 Participants n=483 Participants	36 Participants n=36 Participants	94 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	5 Participants n=10 Participants
History of Hypertension	11 Participants n=93 Participants	21 Participants n=4 Participants	9 Participants n=27 Participants	11 Participants n=483 Participants	33 Participants n=36 Participants	85 Participants n=10 Participants
History of Diabetes	6 Participants n=93 Participants	6 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants	18 Participants n=36 Participants	36 Participants n=10 Participants

PRIMARY outcome

Timeframe: 48-hours following last dose

Population: Evaluable participants

Specific AEs in the study were defined in the protocol to be dose-limiting toxicity events. Any given patient was adjudicated in a binary way to either have had a DLT or not to have had a DLT.

Outcome measures

Measure	120 µg/kg of 3K3A-APC n=15 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=24 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC n=12 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC n=15 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo n=44 Participants Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
Number of Participants With Adverse Events That Meet Dose-limiting Toxicity (DLT) Criteria Specified in Protocol SICH associated with neuroworsening	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events That Meet Dose-limiting Toxicity (DLT) Criteria Specified in Protocol 1-hour post dose aPTT out of range	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events That Meet Dose-limiting Toxicity (DLT) Criteria Specified in Protocol ALT/AST, TBL, ALP, AT values out of range	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events That Meet Dose-limiting Toxicity (DLT) Criteria Specified in Protocol Serious bleeding	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events That Meet Dose-limiting Toxicity (DLT) Criteria Specified in Protocol Abnormal lab value related to study treatment	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Adverse Events That Meet Dose-limiting Toxicity (DLT) Criteria Specified in Protocol Any other AE leading to cessation of dosing	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events That Meet Dose-limiting Toxicity (DLT) Criteria Specified in Protocol Total	0 Participants	2 Participants	1 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 30

Population: Subjects with a Day 30 scan collected.

MRI examination to include-at minimum-T1 and T2 weighted images, as well as diffusion weighted imaging (DWI) and susceptibility weighted imaging (SWI) sequences. Post-tPA microbleeds-defined as hypointensities less than 5mm in diameter seen on SWI-will be counted as tPA-related only if found within the ischemic territory. All other areas of hypointensity on SWI larger than 5mm diameter will be counted as tPA-related regardless of the territory in which they are found. All treated subjects (regardless of dose) will be compared to all placebo subjects using a Pearson chi-square test.

Outcome measures

Measure	120 µg/kg of 3K3A-APC n=43 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=37 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
Number of Participants With a Presence of Measurable Bleeds in the Brain (Hemorrhage and Microbleeds) as Determined by 1.5T MRI Hemorrhage (>0.06mL)	24 Participants	25 Participants	—	—	—
Number of Participants With a Presence of Measurable Bleeds in the Brain (Hemorrhage and Microbleeds) as Determined by 1.5T MRI Microbleed (>0)	7 Participants	8 Participants	—	—	—

SECONDARY outcome

Timeframe: Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI

Population: The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.

Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Outcome measures

Measure	120 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=3 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC n=8 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
PK of 3K3A-APC by Compartmental Analysis (Clearance)	20994 mL/hr Geometric Coefficient of Variation 57.1	17814 mL/hr Geometric Coefficient of Variation 16.7	18504 mL/hr Geometric Coefficient of Variation 49.9	24403 mL/hr Geometric Coefficient of Variation 70.5	—

SECONDARY outcome

Timeframe: Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI

Population: The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.

Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Outcome measures

Measure	120 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=3 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC n=8 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
PK of 3K3A-APC by Compartmental Analysis (Volume of Distribution)	8242 mL Geometric Coefficient of Variation 46.9	6051 mL Geometric Coefficient of Variation 25.6	7164 mL Geometric Coefficient of Variation 79.0	11437 mL Geometric Coefficient of Variation 125	—

SECONDARY outcome

Timeframe: Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI

Population: The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.

Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Outcome measures

Measure	120 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=3 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC n=8 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
PK of 3K3A-APC by Compartmental Analysis (Cmax)	0.957 ng/mL Geometric Coefficient of Variation 59.1	2.37 ng/mL Geometric Coefficient of Variation 11.0	2.80 ng/mL Geometric Coefficient of Variation 77.6	3.32 ng/mL Geometric Coefficient of Variation 138	—

SECONDARY outcome

Timeframe: Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI

Population: The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.

Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Outcome measures

Measure	120 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=3 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC n=8 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
PK of 3K3A-APC by Compartmental Analysis (AUC[0-inf])	0.513 hr▪ng/mL Geometric Coefficient of Variation 64.7	1.16 hr▪ng/mL Geometric Coefficient of Variation 6.79	1.49 hr▪ng/mL Geometric Coefficient of Variation 56.1	2.06 hr▪ng/mL Geometric Coefficient of Variation 92.7	—

SECONDARY outcome

Timeframe: Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI

Population: The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.

Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Outcome measures

Measure	120 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=3 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC n=8 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
PK of 3K3A-APC by Compartmental Analysis (λz)	2.55 1/hr Geometric Coefficient of Variation 13.4	2.94 1/hr Geometric Coefficient of Variation 10.5	2.58 1/hr Geometric Coefficient of Variation 34.9	2.13 1/hr Geometric Coefficient of Variation 45.2	—

SECONDARY outcome

Timeframe: Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI

Population: The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.

Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Outcome measures

Measure	120 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=3 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC n=5 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC n=8 Participants 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	Placebo Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
PK of 3K3A-APC by Compartmental Analysis (Half-life)	0.272 hr Geometric Coefficient of Variation 13.4	0.235 hr Geometric Coefficient of Variation 10.5	0.268 hr Geometric Coefficient of Variation 34.9	0.325 hr Geometric Coefficient of Variation 45.2	—

Adverse Events

120 µg/kg of 3K3A-APC

Serious events: 8 serious events

Other events: 10 other events

Deaths: 0 deaths

240 µg/kg of 3K3A-APC

Serious events: 9 serious events

Other events: 18 other events

Deaths: 2 deaths

360 µg/kg of 3K3A-APC

Serious events: 4 serious events

Other events: 8 other events

Deaths: 3 deaths

540 µg/kg of 3K3A-APC

Serious events: 9 serious events

Other events: 9 other events

Deaths: 4 deaths

3K3A-APC Total

Serious events: 30 serious events

Other events: 45 other events

Deaths: 9 deaths

Placebo

Serious events: 18 serious events

Other events: 36 other events

Deaths: 6 deaths

Serious adverse events

Measure	120 µg/kg of 3K3A-APC n=15 participants at risk 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=24 participants at risk 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC n=12 participants at risk 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC n=15 participants at risk 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	3K3A-APC Total n=66 participants at risk All 3K3A-APC treated groups combined	Placebo n=44 participants at risk Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Blood and lymphatic system disorders Anaemia	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	3.0% 2/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Cardiac disorders Atrial fibrillation	26.7% 4/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	7.6% 5/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	9.1% 4/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Cardiac disorders Bradycardia	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Cardiac disorders Cardiac arrest	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Cardiac disorders Cardiac failure congestive	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Cardiac disorders Intracardiac thrombus	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Cardiac disorders Myocardial infarction	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Cardiac disorders Pericarditis	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
General disorders Chest pain	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Infections and infestations Pneumonia	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Infections and infestations Septic shock	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Infections and infestations Staphylococcal infection	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Infections and infestations Urosepsis	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Blood fibrinogen decreased	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	13.3% 2/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.5% 3/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Blood glucose increased	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Blood potassium decreased	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Blood sodium increased	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Ejection fraction decreased	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Hepatic enzyme increased	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Lymphocyte count decreased	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Troponin increased	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Nervous system disorders Brain oedema	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	26.7% 4/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	7.6% 5/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.8% 3/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Nervous system disorders Carotid artery stenosis	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Nervous system disorders Cerebral haemorrhage	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	12.5% 3/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.5% 3/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.5% 2/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Nervous system disorders Cerebrovascular accident	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	12.5% 3/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	7.6% 5/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.8% 3/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Nervous system disorders Convulsion	13.3% 2/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	3.0% 2/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Nervous system disorders Haemorrhage intracranial	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Psychiatric disorders Agitation	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Respiratory, thoracic and mediastinal disorders Bronchospasm	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	3.0% 2/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	3.0% 2/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Surgical and medical procedures Aneurysm repair	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Vascular disorders Deep vein thrombosis	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Vascular disorders Hypotension	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.2% 1/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.8% 3/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.

Other adverse events

Measure	120 µg/kg of 3K3A-APC n=15 participants at risk 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	240 µg/kg of 3K3A-APC n=24 participants at risk 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	360 µg/kg of 3K3A-APC n=12 participants at risk 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	540 µg/kg of 3K3A-APC n=15 participants at risk 3K3A-APC, q12h for up to 5 doses 3K3A-APC: 3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion	3K3A-APC Total n=66 participants at risk All 3K3A-APC treated groups combined	Placebo n=44 participants at risk Matching placebo, q12h for up to 5 doses Placebo: Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
Blood and lymphatic system disorders Anaemia	33.3% 5/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	16.7% 4/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	16.7% 2/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	13.3% 2/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	19.7% 13/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	13.6% 6/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	12.5% 3/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	13.3% 2/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	9.1% 6/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	13.6% 6/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Cardiac disorders Bradycardia	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	1.5% 1/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	11.4% 5/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Gastrointestinal disorders Constipation	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	20.8% 5/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	9.1% 6/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	9.1% 4/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
General disorders Pyrexia	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 2/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.1% 4/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	9.1% 4/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Infections and infestations Urinary tract infection	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	20.8% 5/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	25.0% 3/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	15.2% 10/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	18.2% 8/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Injury, poisoning and procedural complications Contusion	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	12.5% 3/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.5% 3/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.8% 3/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	16.7% 4/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.1% 4/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.5% 2/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Blood calcium decreased	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 2/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	7.6% 5/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	2.3% 1/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Blood fibrinogen decreased	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	12.5% 3/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.5% 3/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	9.1% 4/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Lymphocyte count decreased	13.3% 2/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.5% 3/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.8% 3/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Investigations Prothrombin time prolonged	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	12.5% 3/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	7.6% 5/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	13.6% 6/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Nervous system disorders Haemorrhage intracranial	13.3% 2/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	16.7% 4/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	33.3% 4/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	26.7% 4/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	21.2% 14/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	36.4% 16/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Nervous system disorders Headache	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	25.0% 6/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	16.7% 2/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	20.0% 3/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	18.2% 12/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	22.7% 10/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Renal and urinary disorders Haematuria	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.7% 1/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.5% 3/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	9.1% 4/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.
Vascular disorders Hypotension	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 2/24 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	8.3% 1/12 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	0.00% 0/15 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	4.5% 3/66 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.	6.8% 3/44 • AEs were collected through Study Day 7 and were followed until resolution or a new baseline was established, up to Study Day 90. SAEs were collected through Study Day 30, and were followed until resolution (or resolution with sequelae), up to Study Day 90. Standard definitions of adverse events and serious adverse events were used.

Additional Information

Patrick Lyden, MD, FAAN, FAHA

Cedars-Sinai Medical Center

Phone: (310) 423-5166

Email: Patrick.Lyden@cshs.org

Results disclosure agreements

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