Trial Outcomes & Findings for The Spot Sign for Predicting and Treating ICH Growth Study (NCT NCT00810888)

Last Updated: 2018-03-16

Results Overview

Thromboembolic complications are defined as development of (1) acute myocardial ischemia; or (2) acute cerebral ischemia; or (3) acute pulmonary embolism

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

92 participants

Primary outcome timeframe

through day 4 after completion of study drug administration

Results posted on

2018-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 - Randomized to Study Drug Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
Overall Study STARTED	10	9	73
Overall Study COMPLETED	10	9	73
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Observational group did not receive study drug so the variable "Time from stroke to study drug administration" is not applicable

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 - Randomized to Study Drug n=10 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 Participants Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.	Total n=92 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 13.1 • n=10 Participants	62.4 years STANDARD_DEVIATION 12.2 • n=9 Participants	60.7 years STANDARD_DEVIATION 34.7 • n=73 Participants	61.3 years STANDARD_DEVIATION 11.0 • n=92 Participants
Sex: Female, Male Female	6 Participants n=10 Participants	3 Participants n=9 Participants	29 Participants n=73 Participants	38 Participants n=92 Participants
Sex: Female, Male Male	4 Participants n=10 Participants	6 Participants n=9 Participants	44 Participants n=73 Participants	54 Participants n=92 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=73 Participants	0 Participants n=92 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=73 Participants	0 Participants n=92 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=73 Participants	0 Participants n=92 Participants
Race (NIH/OMB) Black or African American	1 Participants n=10 Participants	5 Participants n=9 Participants	17 Participants n=73 Participants	23 Participants n=92 Participants
Race (NIH/OMB) White	9 Participants n=10 Participants	4 Participants n=9 Participants	56 Participants n=73 Participants	69 Participants n=92 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=73 Participants	0 Participants n=92 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=9 Participants	0 Participants n=73 Participants	0 Participants n=92 Participants
Region of Enrollment Canada	3 Participants n=10 Participants	1 Participants n=9 Participants	23 Participants n=73 Participants	27 Participants n=92 Participants
Region of Enrollment United States	7 Participants n=10 Participants	8 Participants n=9 Participants	50 Participants n=73 Participants	65 Participants n=92 Participants
Modified Rankin Score (mRS) 0	10 Participants n=10 Participants	6 Participants n=9 Participants	65 Participants n=73 Participants	81 Participants n=92 Participants
Modified Rankin Score (mRS) 1	0 Participants n=10 Participants	3 Participants n=9 Participants	6 Participants n=73 Participants	9 Participants n=92 Participants
Modified Rankin Score (mRS) 2	0 Participants n=10 Participants	0 Participants n=9 Participants	2 Participants n=73 Participants	2 Participants n=92 Participants
Glasgow Coma Score/Scale (GCS)	15 units on a scale n=10 Participants	15 units on a scale n=9 Participants	15 units on a scale n=73 Participants	15 units on a scale n=92 Participants
National Institute of Health Stroke Scale (NIHSS) Score	14.1 units on a scale STANDARD_DEVIATION 3.9 • n=10 Participants	12.1 units on a scale STANDARD_DEVIATION 4.9 • n=9 Participants	10.3 units on a scale STANDARD_DEVIATION 6.2 • n=73 Participants	10.9 units on a scale STANDARD_DEVIATION 6.0 • n=92 Participants
Time from Stroke to Computed Tomography (CT) Scan	158.8 minutes STANDARD_DEVIATION 77.0 • n=10 Participants	90.2 minutes STANDARD_DEVIATION 49.9 • n=9 Participants	159.8 minutes STANDARD_DEVIATION 81.9 • n=73 Participants	152.9 minutes STANDARD_DEVIATION 80.9 • n=92 Participants
Time from Stroke to Study Drug Administration	269.9 minutes STANDARD_DEVIATION 68.3 • n=10 Participants • The Observational group did not receive study drug so the variable "Time from stroke to study drug administration" is not applicable	181.1 minutes STANDARD_DEVIATION 47.1 • n=9 Participants • The Observational group did not receive study drug so the variable "Time from stroke to study drug administration" is not applicable	—	222.5 minutes STANDARD_DEVIATION 70.4 • n=19 Participants • The Observational group did not receive study drug so the variable "Time from stroke to study drug administration" is not applicable

PRIMARY outcome

Timeframe: through day 4 after completion of study drug administration

Population: The analysis population consists of 19 subjects diagnosed as "Spot Positive" on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as "Spot Negative" on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2.

Thromboembolic complications are defined as development of (1) acute myocardial ischemia; or (2) acute cerebral ischemia; or (3) acute pulmonary embolism

Outcome measures

Outcome measures
Measure	Group 1 - Randomized to Study Drug n=10 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 Participants Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
Number of Study Subjects With Life-threatening Thromboembolic Complications	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From baseline to 24 hours

Comparison of only the subjects with a positive spot sign with respect to a categorical measure of hematoma growth from baseline to 24 hours. the outcome of interest is the percent of subjects with hematoma growth \> 33% or \> 6 cc increase in volume, from baseline to 24 hours.

Outcome measures

Outcome measures
Measure	Group 1 - Randomized to Study Drug n=10 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 Participants Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours.	4 Participants	5 Participants	8 Participants

PRIMARY outcome

Timeframe: Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.

The outcome measure is hematoma growth. Groups 2 and 3 only will be compared as Group 1 had administration of study drug which was hypothesized to reduce hematoma growth. Sensitivity was estimated. Sensitivity or true positive rate is defined as, the number of strokes correctly identified as spot positive according to the "gold standard" / the total number of strokes identified as spot positive

Outcome measures

Outcome measures
Measure	Group 1 - Randomized to Study Drug n=10 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 Participants Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
The Sensitivity of the Spot Sign for Predicting Hematoma Growth	4 Participants	5 Participants	8 Participants

PRIMARY outcome

Timeframe: Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.

The outcome measure is hematoma growth. Groups 2 and 3 only will be compared as group 1 had administration of study drug which was hypothesized to reduce hematoma growth. Specificity was estimated. Specificity or true negative rate is defined as, the number of non-spot positive (spot negative) strokes according to the "gold standard" / the total number of strokes identified as not spot positive.

Outcome measures

Outcome measures
Measure	Group 1 - Randomized to Study Drug n=10 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 Participants Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
The Specificity of the Spot Sign for Predicting Hematoma Growth	4 Participants	5 Participants	8 Participants

SECONDARY outcome

Timeframe: through day 4 after completion of study drug

Evidence of a deep venous thrombosis or an elevation of troponin within 4 days of completion of study drug administration that are not associated with ECG changes that could be related to the study drug

Outcome measures

Outcome measures
Measure	Group 1 - Randomized to Study Drug n=10 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 Participants Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
Number of Participants With Other Potentially Study Drug Related Thromboembolic Complications Such as Deep Venous Thrombosis (DVT) and Elevations in Troponin Not Associated With ECG Changes	0 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 90 days (+/- 7 days) from time of study enrollment

The modified Rankin Scale (0 is best, 5 is worst - non dead, 6 is dead) was used to define a bad outcome; categorized as a score \>=5 versus \<5. As the aim of the study was to examine the effect of rFIV!!a only the randomized groups, 1 and 2, defined as spot positive by CTA were compared.

Outcome measures

Outcome measures
Measure	Group 1 - Randomized to Study Drug n=10 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 Participants Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
Number of Spot Positive Subjects With 90-day Outcome of Modified Rankin Scale Score >= 5	3 Participants	1 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline head CT scan within 5 hours, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.

Population: The analysis population consists of 19 subjects diagnosed as "Spot Positive" on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as "Spot Negative" on CT who were followed prospectively with no study intervention. Overall agreement was assessed but reported by group below.

The CTA was originally interpreted by the site radiologist so that subjects could be identified as having a positive spot sign for eligibility for randomization. The positive spot sign is indicative that there is potential for further hemorrhagic growth and these subjects were thus eligible to be randomized to receive investigational drug or placebo. The CTA scans were subsequently assessed by the study radiologist and compared for agreement.

Outcome measures

Outcome measures
Measure	Group 1 - Randomized to Study Drug n=10 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 Participants Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
Number of Participants With Agreement Between the Clinical Site Radiologists and the Study Radiologist With Respect to Identification of a Positive Spot Sign or the Absence of Positive Spot Sign on CTA	10 Participants	6 Participants	69 Participants

SECONDARY outcome

Timeframe: 24 hours (+/- 3 hours) from baseline CT scan

Percent change in total volume (intracerebral hemorrhage (ICH) plus intraventricular hemorrhage (IVH)) from baseline CT to 24 hour CT. Percent change is expressed as difference between 24 hour total volume and baseline total volume divided by baseline total volume, expressed as a percentage. In order to examine the effect of rFIVIIa, the randomized groups, Group 1 and Group 2 only were statistically compared.

Outcome measures

Outcome measures
Measure	Group 1 - Randomized to Study Drug n=10 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 Participants Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 Participants Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
Percent Change in Total Hemorrhage Volume (Intracerebral Hemorrhage (ICH) Plus Intraventricular Hemorrhage (IVH)).	13.51 Percent change from baseline to 24 hours Interval -0.84 to 33.08	20.96 Percent change from baseline to 24 hours Interval 14.07 to 96.57	5.12 Percent change from baseline to 24 hours Interval 0.28 to 16.64

Adverse Events

Group 1 - Randomized to Study Drug

Serious events: 4 serious events

Other events: 9 other events

Deaths: 2 deaths

Group 2 - Randomized to Placebo

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Group 3 - Observation Only Arm

Serious events: 16 serious events

Other events: 65 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Dr Jane Khoury, Professor of Pediatrics

Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center

Phone: 513-636-2690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Group 1 - Randomized to Study Drug n=10 participants at risk Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 participants at risk Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 participants at risk Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
Nervous system disorders Cerebral Edema	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	2.7% 2/73 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Cardiac disorders New onset Afib	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Congenital, familial and genetic disorders Atreriovenous malformation (AVM)	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	4.1% 3/73 • Number of events 3 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Gastrointestinal disorders Oropharyngeal disorder	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Infections and infestations Ventilator aquired pneuminia	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Infections and infestations Gram negative bacteremia	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Injury, poisoning and procedural complications RESPIRATORY DISTRESS SECONDARY TO TRACH OBSTRUCTION	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Investigations Elevated Troponin	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Injury, poisoning and procedural complications Left acute on chronic subdural hematoma	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Musculoskeletal and connective tissue disorders Weakness left leg	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Seizure	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	22.2% 2/9 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	2.7% 2/73 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Slurred speech	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Increasing mass effect	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders POSSIBLE MCA VESSEL THROMBOSIS WITHOUT ISCHEMIC STROKE	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Significant expansion of ICH	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Cortical vein thrombosis	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Neurologic deterioration	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	4.1% 3/73 • Number of events 3 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Neuroleptic malignant syndrome	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Subarachnoid hemorrhage	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders WORSENING PERIHEMATOMAL EDEMA AND INCREASING MIDLINE SHIFT	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Renal and urinary disorders Acute exacerbation of renal failure	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Respiratory, thoracic and mediastinal disorders O2 desats on ventilator	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Psychiatric disorders Mental status changes	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	2.7% 2/73 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	4.1% 3/73 • Number of events 3 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Respiratory, thoracic and mediastinal disorders Respiratory distress	20.0% 2/10 • Number of events 4 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Vascular disorders Deep vein thrombosis (DVT)	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	2.7% 2/73 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Vascular disorders Hemorrhage expansion	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Vascular disorders Malignant hypertension	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Vascular disorders Hypertensive urgency	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Vascular disorders PE	0.00% 0/10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken

Other adverse events
Measure	Group 1 - Randomized to Study Drug n=10 participants at risk Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo . Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).	Group 2 - Randomized to Placebo n=9 participants at risk Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg). Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)	Group 3 - Observation Only Arm n=73 participants at risk Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a prospective observational group.
Blood and lymphatic system disorders Leukocytosis	20.0% 2/10 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	2.7% 2/73 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Blood and lymphatic system disorders Leukopenia	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Cardiac disorders Bradycardia	20.0% 2/10 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Cardiac disorders Congestive heart failure	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Cardiac disorders Tachycardia	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	4.1% 3/73 • Number of events 3 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Gastrointestinal disorders Constipation	60.0% 6/10 • Number of events 6 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	22.2% 2/9 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	13.7% 10/73 • Number of events 10 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Gastrointestinal disorders Diarrhea	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	5.5% 4/73 • Number of events 4 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Gastrointestinal disorders Distended abdomen	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Gastrointestinal disorders Dysphagia	20.0% 2/10 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	4.1% 3/73 • Number of events 3 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Gastrointestinal disorders Nausea	30.0% 3/10 • Number of events 3 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	19.2% 14/73 • Number of events 14 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Gastrointestinal disorders Rectal pain	10.0% 1/10 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
General disorders Chest pain	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	2.7% 2/73 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
General disorders Fever	30.0% 3/10 • Number of events 3 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	33.3% 3/9 • Number of events 4 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	8.2% 6/73 • Number of events 6 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
General disorders Generalized pain	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	9.6% 7/73 • Number of events 7 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
General disorders Pain with catherization	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
General disorders Right hand PIV infultration	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Infections and infestations Candidiasis	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Infections and infestations Tracheitis	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Infections and infestations Urinary tract infection	50.0% 5/10 • Number of events 5 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	16.4% 12/73 • Number of events 13 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Injury, poisoning and procedural complications Bruising on forearms	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Injury, poisoning and procedural complications Fall from bed	20.0% 2/10 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Investigations ELEVATED ERYTHROCYTE SEDIMENTATION RATE	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Investigations Elevated troponin	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	22.2% 2/9 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	6.8% 5/73 • Number of events 5 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Investigations Prolonged prothrombin time	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Metabolism and nutrition disorders Hyperglycemia	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	44.4% 4/9 • Number of events 4 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	17.8% 13/73 • Number of events 13 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Metabolism and nutrition disorders Hypocalcemia	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Metabolism and nutrition disorders Hypokalemia	30.0% 3/10 • Number of events 3 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	22.2% 2/9 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	23.3% 17/73 • Number of events 17 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Metabolism and nutrition disorders Hyponatremia	20.0% 2/10 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Musculoskeletal and connective tissue disorders Back pain	20.0% 2/10 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	5.5% 4/73 • Number of events 4 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Musculoskeletal and connective tissue disorders Leg pain	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	1.4% 1/73 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Musculoskeletal and connective tissue disorders Right shoulder rotator cuff tear	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Aneurysm	10.0% 1/10 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Headache	50.0% 5/10 • Number of events 6 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	44.4% 4/9 • Number of events 4 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	15.1% 11/73 • Number of events 11 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Nervous system disorders Somulence	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	2.7% 2/73 • Number of events 2 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Psychiatric disorders Confusion	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Psychiatric disorders Depression	30.0% 3/10 • Number of events 3 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	11.1% 1/9 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	6.8% 5/73 • Number of events 5 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Renal and urinary disorders Renal failure	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Renal and urinary disorders Hematuria	10.0% 1/10 • Number of events 1 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/73 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken
Renal and urinary disorders Urinary retension	30.0% 3/10 • Number of events 3 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	0.00% 0/9 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken	5.5% 4/73 • Number of events 4 • Adverse events were collected out to 90 days from stroke onset Adverse events and serious adverse events were defined as per clinicaltrials.gov A case report form (CRF) was used to collect: 1\. Presence, description and type of adverse events; 2. Severity (mild, moderate, severe, life-threatening, death); 3. Serious (yes, no); 4. Expected (yes, no); 5. Date/Time of onset; 6. Outcome (resolved, continuing, death); 7. Date of resolution; 8. Relation to disease; 9. Relationship to study project; 10. Action taken