Stroke
Item
Have a confirmed diagnosis of stroke according to the World Health Organization definition
boolean
C0750484 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0043237 (UMLS CUI [1,3])
Onset of stroke
Item
Stroke onset must be within the last 24-72 hours
boolean
C0521116 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Radiologically confirmed stroke, ischemic and supratentorial, diameter or volume
Item
Radiologically confirmed stroke, ischemic and supratentorial. The diameter of the ischemic lesion was >15 mm in any single direction or the volume was >4cc.
boolean
C0043299 (UMLS CUI [1,1])
C0948008 (UMLS CUI [1,2])
C0441938 (UMLS CUI [1,3])
C0948008 (UMLS CUI [2,1])
C2700258 (UMLS CUI [2,2])
C0948008 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
Radiologically confirmed stroke, intracerebral hemorrhage, intracerebral hemorrhage score
Item
Radiologically confirmed stroke, intracerebral hemorrhage that was supratentorial, deep (i.e., blood must not directly contact cerebral cortex) and with minimal or no intraventricular extension. The Intracerebral Hemorrhage (ICH) score must have been 0-2 and was calculated based on age, Glasgow Coma Scale score and the initial computed tomography (CT) or MRI findings for the index stroke. (Based on Protocol Amendment 4, subjects with ICH were not enrolled in Germany.)
boolean
C0043299 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C2937358 (UMLS CUI [1,3])
C0441938 (UMLS CUI [1,4])
C0205125 (UMLS CUI [1,5])
C1298908 (UMLS CUI [1,6])
C1517569 (UMLS CUI [1,7])
C0231448 (UMLS CUI [1,8])
C0043299 (UMLS CUI [2,1])
C0038454 (UMLS CUI [2,2])
C2937358 (UMLS CUI [2,3])
C0441938 (UMLS CUI [2,4])
C0205125 (UMLS CUI [2,5])
C0547040 (UMLS CUI [2,6])
C1517569 (UMLS CUI [2,7])
C0231448 (UMLS CUI [2,8])
C2937358 (UMLS CUI [3,1])
C0449820 (UMLS CUI [3,2])
NIHSS score
Item
Have a total NIHSS score of 3-21
boolean
C1697238 (UMLS CUI [1])
Upper and/or lower limb deficit
Item
Have an upper and/or lower limb deficit defined as: a. Score of 1-3 on the NIHSS Motor Arm question, and palpable and observable voluntary extension or flexion of the fingers. AND/OR b. Score of 1-3 on the NIHSS Motor Leg question
boolean
C1697238 (UMLS CUI [1,1])
C0003794 (UMLS CUI [1,2])
C2987487 (UMLS CUI [1,3])
C1697238 (UMLS CUI [2,1])
C0023220 (UMLS CUI [2,2])
C2987487 (UMLS CUI [2,3])
Age
Item
Aged 18-90, inclusive
boolean
C0001779 (UMLS CUI [1])
Physical, occupational and speech rehabilitation therapy likely
Item
Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits
boolean
C0949766 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
C0037831 (UMLS CUI [2,1])
C0750492 (UMLS CUI [2,2])
C1318464 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
Both doses of investigational product
Item
Reasonable likelihood of receiving both doses of investigational product
boolean
C0750492 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1706086 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
Informed consent
Item
Was able to provide written and dated informed consent. Where the subject was unable to give consent, consent may have been obtained from the subject’s legally authorized representative in accordance with national legislation and local ethics committee guidelines. When able to do so, the subject was to be re-consented to continue in the study in the case where the consent was obtained from the legal representative in the first instance
boolean
C0021430 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C0030701 (UMLS CUI [2,3])
Sex
Item
Male subjects and females of non-child-bearing potential are allowed to participate in this study
boolean
C0079399 (UMLS CUI [1])
Previous symptomic stroke
Item
History of a previous symptomatic stroke within 3 months prior to study entry
boolean
C0332185 (UMLS CUI [1,1])
C0559159 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Significant disability prior to stroke, rankin score
Item
Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke Rankin score of >2
boolean
C0231170 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,3])
C0451405 (UMLS CUI [1,4])
Active and uncontrolled depression
Item
Presence of depression that is active and not adequately controlled such that it interferred with major activities of daily living immediately prior to the current stroke
boolean
C0205177 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Unresponsive, not alert
Item
Subjects who are not alert or are unresponsive
boolean
C0241526 (UMLS CUI [1,1])
C1697238 (UMLS CUI [1,2])
C3665546 (UMLS CUI [2,1])
C1298908 (UMLS CUI [2,2])
C1697238 (UMLS CUI [2,3])
aphasia affecting assessments
Item
Presence of significant aphasia as likely to confound or interfere with completion of the study assessments
boolean
C0003537 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0431080 (UMLS CUI [1,3])
symptomatic Peripheral neuropathy, diabetic neuropathy
Item
Presence of peripheral neuropathy, including diabetic neuropathy, which was clinically active and symptomatic at time of screening.
boolean
C0231220 (UMLS CUI [1,1])
C0031117 (UMLS CUI [1,2])
C0011882 (UMLS CUI [2])
Neurological or psychiatric disease
Item
Presence of neurological or psychiatric disease, such as dementia or mild cognitive impairment, prior to study entry that is likely to confound clinical evaluations
boolean
C0027765 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0431080 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C0679823 (UMLS CUI [1,6])
C0004936 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0431080 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C0008976 (UMLS CUI [2,5])
C0679823 (UMLS CUI [2,6])
C0497327 (UMLS CUI [3])
C1270972 (UMLS CUI [4])
Demyelinating disease
Item
Presence of a demyelinating disease, such as multiple sclerosis
boolean
C0011303 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
Other chronic co-morbid conditions or unstable acute systemic illnesses affecting study completion/life expectancy
Item
Evidence of other chronic co-morbid conditions or unstable acute systemic illnesses which, in the opinion of the investigator, could have shortened the subject's survival or limited his/her ability to complete the study
boolean
C0205394 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2826674 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C0008679 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0023671 (UMLS CUI [2,4])
C0443343 (UMLS CUI [3,1])
C0205178 (UMLS CUI [3,2])
C0442893 (UMLS CUI [3,3])
C0392760 (UMLS CUI [3,4])
C2826674 (UMLS CUI [3,5])
C0443343 (UMLS CUI [4,1])
C0205178 (UMLS CUI [4,2])
C0442893 (UMLS CUI [4,3])
C0392760 (UMLS CUI [4,4])
C0023671 (UMLS CUI [4,5])
Sensitivity to heparin or heparin-induced thrombocytopenia
Item
History of sensitivity to heparin or heparin-induced thrombocytopenia
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0019134 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0272285 (UMLS CUI [2,2])
QTcB, uncorrected QT, bundle branch block
Item
Presence of QTc > 500 msec; or uncorrected QT >600msec (machine or manual over-read) on baseline ECG. If bundle branch block was present, then QTc must not have been > 530 msec.
boolean
C1882512 (UMLS CUI [1])
C1287082 (UMLS CUI [2])
C0006384 (UMLS CUI [3])
Contraindication to TMS
Item
Contraindication to TMS
boolean
C1301624 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
C0025552 (UMLS CUI [2,1])
C0460148 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
C0028811 (UMLS CUI [3,1])
C0016542 (UMLS CUI [3,2])
C3178787 (UMLS CUI [3,3])
C1268086 (UMLS CUI [3,4])
C0441655 (UMLS CUI [4,1])
C0016542 (UMLS CUI [4,2])
C3178787 (UMLS CUI [4,3])
C1268086 (UMLS CUI [4,4])
C2347852 (UMLS CUI [5,1])
C0234976 (UMLS CUI [5,2])
C0262926 (UMLS CUI [6,1])
C0036572 (UMLS CUI [6,2])
C0262926 (UMLS CUI [7,1])
C0014544 (UMLS CUI [7,2])
C0006118 (UMLS CUI [8])
C0332665 (UMLS CUI [9,1])
C0270611 (UMLS CUI [9,2])
Contraindication to MRI
Item
Contraindication to MRI
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0025552 (UMLS CUI [2,1])
C0460148 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
C0028811 (UMLS CUI [3,1])
C0016542 (UMLS CUI [3,2])
C3178787 (UMLS CUI [3,3])
C1268086 (UMLS CUI [3,4])
C0441655 (UMLS CUI [4,1])
C0016542 (UMLS CUI [4,2])
C3178787 (UMLS CUI [4,3])
C1268086 (UMLS CUI [4,4])
C0008909 (UMLS CUI [5])
Participation in other clinical trial
Item
Participation in any investigational rehabilitation paradigm targeting stroke recovery during the duration of this study
boolean
C0205394 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2926735 (UMLS CUI [1,5])
C0008976 (UMLS CUI [1,6])
Participation in other clinical trial, investigational product
Item
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)
boolean
C0205394 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Sensitivity to investigational product or components thereof
Item
History of sensitivity to GSK249320, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicated their participation
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0205394 (UMLS CUI [4,1])
C0020517 (UMLS CUI [4,2])
Pregnant females, Urine hcg test
Item
Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test at screening or prior to dosing
boolean
C0032961 (UMLS CUI [1])
C1141639 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0430056 (UMLS CUI [2,3])
Lactating females
Item
Lactating females
boolean
C0006147 (UMLS CUI [1])
Protocol compliance
Item
Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])