Proof of Concept (POC) in Patients With Ischaemic Stroke | NCT01808261

Status Module

Description Module

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo is a clear, colorless solution (50mM acetate buffer, pH 5.5 containing 0.02% (w/v) polysorbate-80 and made isotonic with 111.2 mM sodium chloride). Placebo is for intravenous (IV) use only.	Drug: Placebo
GSK249320 100/mg	Active Comparator	Clear to opalescent, colorless to pale yellow or pale brown, and is supplied as a sterile, concentrated solution (1000mg/vial). GSK249320 is for IV use only.	Drug: GSK249320 100/mg

Name	Type	Description	Arm Group Labels	Other Names
GSK249320 100/mg	Drug	Clear to opalescent, colorless to pale yellow or pale brown, and is supplied as a sterile, concentrated solution (1000mg/vial). GSK249320 is for IV use only.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline (BL) to Month 3/ Day 90 in Gait Velocity	Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 meter (m) distance and were allowed to use their normal assistive devices. The time (seconds[s]) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.	BL (Day 1) and Month 3/Day 90

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From BL to Month 6/ Day 180 in Gait Velocity	Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 m distance and were allowed to use their normal assistive devices. The time (s) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a confirmed diagnosis of stroke according to the World Health Organization definition which is, 'a rapid onset event of vascular origin reflecting a focal disturbance of cerebral function, excluding isolated impairments of higher function, and persisting longer than 24 hours [World Health Organization, 1989].
Stroke onset must be within the last 24-72 hours of the first infusion of Investigational Product. Time of stroke onset is defined at the time at which the patient/relative is first aware of the stroke deficit. For patients who awake with deficits, or who are found unconscious, the time of onset is defined as the time at which they were last known to be symptom free.
Have a stroke that is radiologically confirmed to be ischemic and supratentorial. The diameter of the ischemic lesion is >15mm in any single direction or the volume is >4cc. See the Study Procedures Manual (SPM) for guidance on how to calculate the lesion size.
Have a total NIHSS score of 3-21.
Have a lower limb deficit from the incident stroke which is defined as a score of 1-4 on the NIHSS Motor Leg question (question #6).
Aged 18-90, inclusive.
Expectation the subject will receive standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits.
Male subjects and female subjects of non-child-bearing and child-bearing potential are allowed to participate in this study. See Section 11, Appendix 1 for definitions. Females of child-bearing potential must have a negative pregnancy test prior to enrollment and must agree to use one of the contraceptive methods specified in Section 11, Appendix 1.

Exclusion Criteria:

Ability to walk >0.8m/s as measured by the Gait Velocity assessment.
History of a previous symptomatic stroke within 3 months prior to study entry.
Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke Rankin score of >2.
Subjects who are not alert or are unresponsive as defined by a score of 2 or 3 on the NIHSS Level of Consciousness question (Question 1a).
Presence of significant aphasia likely to confound or interfere with completion of the study assessments.
Presence of a significant pre-existing gait deficit prior to study entry that is likely to confound clinical evaluations
Presence of pre-existing neurologic or psychiatric disease which is active and not adequately controlled such that it interfered with major activities of daily living immediately prior to the current stroke and is likely to interfere with study participation/visits or confound clinical evaluations.
The subject poses a significant suicide risk, in the opinion of the investigator.
Current or chronic history of liver disease, known hepatic or biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones), or known history of hepatitis B or hepatitis C infection. A positive hepatitis B or hepatitis C result on the GSK labs drawn at baseline/Study Day 1 do not exclude a subject from continuing in the study unless there are associated clinical signs/symptoms of liver disease; however, the subject should be treated as clinically indicated and the GSK Medical Monitor should be contacted for further discussion.
Presence of either a central or peripheral demyelinating disease, such as multiple sclerosis or IgM monoclonal gammopathy of unknown significance (MGUS).
Expected death due to the incident stroke, or evidence of a chronic co-morbid condition or unstable acute systemic illness which, in the opinion of the investigator, could shorten the subject's survival such that it would limit his/her ability to complete the study.
Presence of the following ECG values on baseline ECG: QTc > 500 msec (using either Bazett's formula (QTcB) or Fridericia's formula (QTcF)); or uncorrected QT >600msec (machine or manual over-read). If the ECG indicates a prolonged QTc interval value outside these limits, two further ECGs should be performed during the same sitting and the average QTc value of these triplicate ECGs calculated. If the average value exceeds the stated limits, the subject is not eligible.
Participation in any investigational rehabilitation paradigm targeting stroke recovery during the duration of this study.
Have a contraindication to MRI as per local hospital practice/guidelines.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Prior treatment with GSK249320.
History of sensitivity to Investigational Product excipients (acetate buffer, polysorbate 80 and sodium chloride) that, in the opinion of the investigator or GSK Medical Monitor, contraindicates the subject's participation.
Pregnant females as determined by positive urine hCG test prior to enrollment.
Lactating females.
Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Orange	California	92868-4280	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
28228578	Derived	Cramer SC, Enney LA, Russell CK, Simeoni M, Thompson TR. Proof-of-Concept Randomized Trial of the Monoclonal Antibody GSK249320 Versus Placebo in Stroke Patients. Stroke. 2017 Mar;48(3):692-698. doi: 10.1161/STROKEAHA.116.014517. Epub 2017 Feb 22.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
104615	Annotated Case Report Form	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo administered as two intravenous (IV) infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 milliliters (mL) IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change From Baseline (BL) to Month 3/ Day 90 in Gait Velocity

Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 meter (m) distance and were allowed to use their normal assistive devices. The time (seconds[s]) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.

Intent-To-Treat (ITT) population comprised of participants who received at least 1 infusion of investigational product and had at least 1 post-Baseline efficacy assessment.

Posted

Mean

Standard Deviation

m/s

BL (Day 1) and Month 3/Day 90

ID	Title	Description
OG000	Placebo	Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
OG001	GSK249320 15 mg/kg	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

Units	Counts
Participants	OG00060 OG00160

Title

Denominators

Categories

Title	Measurements
	OG0000.5417± 0.062 OG0010.5859± 0.0535

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.	Bayesian method		0.713	P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 3/Day 90.	Mean Difference (Net)	0.0443	Standard Error of the Mean	0.0809		95	-0.119	0.2					Other

Secondary

Mean Change From BL to Month 6/ Day 180 in Gait Velocity

Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 m distance and were allowed to use their normal assistive devices. The time (s) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.

ITT Population.

Posted

Mean

Standard Deviation

m/s

BL (Day 1) and Month 6/Day 180

ID	Title	Description
OG000	Placebo	Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
OG001	GSK249320 15 mg/kg	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

Secondary

Number of Participants With Indicated Transition From One Gait Velocity Category to Another Category at the Indicated Time Points

Participants were categorized at each visit into the following gait velocity categories: 0 m/s, >0 to <0.4 m/s, >=0.4 m/s to 0.8 m/s and >0.8m/s. A distinction was made between participants who are too incapacitated to walk (i.e., gait velocity = 0m/s) and participants for whom the gait velocity assessment was not performed due to another reason (i.e., truly missing data). Participants were asked to walk at their usual or normal pace and using their normal assistive devices. Two trials of gait velocity were conducted at each time point. The number of participants transitioning from one gait velocity category to another category was assessed at each post-Baseline visit and was presented in terms of the following transition categories: worsened, no change, improved 1 level, improved 2 levels and improved 3 levels. By-visit sample sizes vary due to missing data or early termination of the study, missing data was not imputed.

PP Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments. Only participants with data available at the specified time points were analyzed.

Posted

Count of Participants

Participants

BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180.

ID	Title	Description
OG000	Placebo - PP	Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). Placebo - Per Protocol (PP) Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.

Secondary

Change From BL in Dexterity as Measured by Box and Blocks Test

Dexterity is ability of person to use hands skillfully in performing a task. Box and Blocks test is an objective, gross manual dexterity test in individuals with upper limb impairments. Participants were asked to move small wooden blocks from one side of a partitioned box to other. The score was determined by number of blocks transferred within a 60 second time period. Both affected and unaffected arms were tested, starting with the unaffected arm. Change from BL was calculated as the individual post- BL value minus BL value. A higher number of displaced blocks indicated a better gross dexterity and a low number of displaced blocks indicated poor gross dexterity. It was analyzed using fixed effects for treatment, visit, treatment by visit interaction, sex, age, Baseline National Institute of Health stroke scale (NIHSS) total score, BL number of blocks transferred by the affected and unaffected arms, country and presence of concomitant medications that potentially impact recovery.

PP Population.

Posted

Least Squares Mean

Standard Error

Number of blocks

BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180

ID	Title	Description
OG000	Placebo - PP	Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). Placebo PP Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.

Secondary

Number of Participants Experiencing Falls

The number of participants who experienced at least one fall between BL to Day 90 and BL to Day 180 is summarized.

Safety population is defined as participants who had received at least one infusion of investigational product.

Posted

Count of Participants

Participants

BL (Day 1) Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Number of Falls Over Time

The number of participants who experienced 1, 2, 3 or >=4 falls between BL to Day 90 and BL to Day 180 is summarized. By-visit sample sizes vary due to missing data or early termination of the study. The participants who experienced atleast one-fall were reported

Safety Population.

Posted

Count of Participants

Participants

BL (Day 1), Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or all events of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment is exercised in other situations.

Safety population.

Posted

Count of Participants

Participants

Up to 14 months

ID	Title	Description
OG000	Placebo	Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
OG001	GSK249320 15/mg	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

Secondary

Number of Participants With Events Common to Stroke

Events common to stroke were those events that commonly occurred after a stroke and are generally associated with the underlying stroke or the progression of stroke. These included joint or soft tissue pain, bladder incontinence, depression/mood disorder, urinary tract infection, dysphagia, bowel incontinence, dysarthia, confusion, spasticity, limb edema, aspiration pneumonia, hemorrhagic transformation (symptomatic or asymptomatic), pressure ulcers, progression of stroke, malnutrition, deep vein thrombosis, brain herniation, pulmonary embolism, seizures, and falls.

Safety Population.

Posted

Count of Participants

Participants

From Day 1 until early withdrawal, death, Month 6/Day 180

ID	Title	Description
OG000	Placebo	Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
OG001	GSK249320 15/mg	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

Secondary

Change From BL in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Safety was measured by monitoring vital signs including blood pressure. The BL for DBP and SBP was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millimeters of mercury

BL (Day 1) , Day 6, Day 180 and early withdrawal (EW) visit

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From BL in Vitals Signs-Heart Rate

Safety was measured by monitoring vital signs including heart rate. The BL for heart rate was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-BL value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study. BL was defined as Day 1.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Beats per minute

Day 1, Day 6, Day 180 and EW visit

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From BL in ECG Parameter-Heart Rate

A single 12-lead ECG was obtained at each time point that measured heart rate. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Beats per minute

BL (Day 1) Day 6, Day 30 and EW visit

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From BL in ECG Parameters

A single 12-lead ECG was obtained at each time point and the following ECG intervals were determined: PR, QRS, QT, RR and corrected QT (QTc), QT interval corrected by Bazett's formula (QTcB), QT interval corrected by Fridericia's formula (QTcF). BL for ECG parameters was the value of Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Milliseconds

BL (Day 1), Day 6, Day 30 and EW visit

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From BL in Clinical Chemistry- Albumin and Total Protein

ALB and TP were measured at BL, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Grams per liter

BL (Day 1), Day 6, Day 30, Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From BL in Clinical Chemistry-urea/Blood Urea Nitrogen (BUN), Sodium (Na), Potassium (K), Glucose (Gluc), Chloride (Cl), Calcium (Ca)

Ca, Cl, Gluc, K, Na and BUN were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millimoles per liter

BL (Day 1), Day 6, Day 30, Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From BL in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)

ALP, ALT and AST were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

International units per liter

BL (Day 1), Day 6, Day 30, Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From BL in Clinical Chemistry- Direct Bilirubin, Total Bilirubin, Creatinine

Direct bilirubin, total bilirubin and creatinine were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Micromoles per liter

BL (Day 1), Day 6, Day 30, Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From BL in Eosinophils (EOS), Lymphocytes (LYM), Total Absolute Neutrophil Count (ANC), Platelet (PLT) Count, White Blood Cell (WBC) Count

EOS, LYM, Total ANC, PLT count and WBC count were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Giga (10^9 cells) per liter

BL (Day 1), Day 6, Day 30, Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From BL in Hematology- Hemoglobin

Hemoglobin was measured at BL Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. . By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Grams per liter

BL (Day 1), Day 6, Day 30, Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From Baseline in Hematology- Hematocrit

Hematocrit was measured at Baseline, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Ratio

BL (Day 1), Day 6, Day 30, Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Change From BL in NIHSS Total Score

The NIHSS is a 15 item, standardized, disease-specific, deficit scale which measures neurological impairment (level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect) and is used to quantify participant status by measuring the severity of the stroke as assessed by NIHSS certified study personnel. The total NIHSS score is calculated as the sum of responses to the 15 items. The total NIHSS score ranges from 0-42, with a higher score indicative of a more severe impairment. By-visit sample sizes vary due to missing data or early termination of the study. Change from BL was calculated as the individual post-Baseline value minus the BL value. BL was defined as the value at Day 1.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

BL (Day 1), Day 30, Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety

Secondary

Number of Participants With Suicidal Ideation Via Columbia Suicide Severity Rating Scale (CSSRS)

C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both suicidality behavior and ideation. For Suicidal Ideation (SI), participants were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). SI intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation.

Safety Population. Number of participants with at least one on-treatment C-SSRS assessment were included.

Posted

Count of Participants

Participants

Da y 1, Da y 6, Day 30, Day 60, Day 90 and Day 180

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Secondary

Maximum Observed Plasma Concentration (Cmax) for GSK249320

Cmax is the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on Day 6. Due to early termination of the study, this data was not collected.

The Pharmacokinetics (PK) population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit. Data not collected due to early termination of study.

Posted

Pre-dose and post-dose up to Day 180

ID	Title	Description
OG000	GSK249320 15 mg/kg - PK	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.

Units	Counts
Participants	OG000

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) GSK249320

Tmax is the time of the occurrence of Cmax. The Cmax is defined as the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on day 6. Due to early termination of the study data for Tmax was not collected.

PK population. Due to early termination of the study, data for Tmax was not collected

Posted

Pre-dose and post-dose up to Day 180

ID	Title	Description
OG000	GSK249320 15 mg/kg - PK	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.

Units	Counts
Participants	OG000

Secondary

PK as Measured by Plasma Decay Half-life (t1/2) GSK249320

Blood samples were collected for determination of plasma concentrations of GSK249320. Terminal phase half-life was derived from the plasma concentration-time data. Only participants in the GSK249320 15 mg/kg group were analyzed.

PK Population.

Posted

Median

Full Range

Days

Up to Day 180

ID	Title	Description
OG000	GSK249320 15 mg/kg - PK	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration-time Curve From 0 to 5 Days [AUC(0-5d)] and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] for GSK249320

Blood samples were collected for determination of plasma concentrations of GSK249320. AUC (0-5d) and AUC (0-inf) were derived from the plasma concentration-time data. AUC(0-5d) is the model predicted AUC over the planned TAU of 5 days. Only participants in the GSK249320 15 mg/kg group were analyzed.

PK Population.

Posted

Geometric Mean

Geometric Coefficient of Variation

Milligrams/milliliter*hour

Pre-dose and post-dose up to Day 180

ID	Title	Description
OG000	GSK249320 15 mg/kg - PK	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.

Units	Counts
Participants	OG000

Secondary

Clearance (CL) for GSK249320

Blood samples were collected for determination of plasma concentrations of GSK249320. CL was derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.

PK Population.

Posted

Geometric Mean

Geometric Coefficient of Variation

Milligrams/kilograms/hour

Up to Day 180

ID	Title	Description
OG000	GSK249320 15 mg/kg - PK	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.

Units	Counts
Participants	OG000

Secondary

Volume of Distribution (V1 and V2) and Volume at Steady State (Vss) for GSK249320

Blood samples were collected for determination of plasma concentrations of GSK249320. V1, V2 and Vss were derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.

PK Population

Posted

Geometric Mean

Geometric Coefficient of Variation

milliliters/kilogram

Up to Day 180

ID	Title	Description
OG000	GSK249320 15 mg/kg - PK	Participants received GSK249320 15 mg/kg, administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). PK population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit.

Units	Counts
Participants	OG000

Secondary

Antibodies Against GSK249320, Assessed Using Electrochemi-luminescent Assay (ECL) Assay

Blood samples were collected and the presence of antibodies against GSK249320 was assessed using ECL assays. Positive result indicated presence of antibodies and negative result indicated absence of antibodies. Confirmed samples with presence of antibodies were further characterized for neutralizing activity as binding antibody (BAb) and neutralising antibody (NAb) by a neutralization assay.By-visit sample sizes vary due to missing data or early termination of the study.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Count of Participants

Participants

Day 1, Day 30, Day 180, EW visit and Follow-up visit

ID	Title	Description
OG000	Placebo - Safety	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.
OG001	GSK249320 15 mg/kg - Safety	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0011 affected65 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0011 affected65 at risk
Atrial flutter	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Cardiac arrest	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0011 affected65 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0011 affected65 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0011 affected65 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0011 affected65 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Brain edema	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Cerebral hemorrhage	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0011 affected65 at risk
Ischemic cerebral infarction	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0011 affected65 at risk
Stroke in evolution	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected68 at risk EG0010 affected65 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0011 affected65 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0011 affected65 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0011 affected65 at risk
Hypertensive emergency	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected68 at risk EG0010 affected65 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected68 at risk EG0013 affected65 at risk
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected68 at risk EG0012 affected65 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected68 at risk EG0014 affected65 at risk
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected68 at risk EG00112 affected65 at risk
Insomnia	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected68 at risk EG0015 affected65 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected68 at risk EG00113 affected65 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected68 at risk EG0015 affected65 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected68 at risk EG0014 affected65 at risk
Urinary tract infection	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected68 at risk EG0010 affected65 at risk

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	Placebo	Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
BG001	GSK249320 15 mg/kg	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo administered as two IV infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).	5	68	16	68	25	68
EG001	GSK249320 15 mg/kg	Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).	2	65	9	65	32	65