ID

38251

Beschreibung

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the eligibility criteria. It has to be filled in at Day 1.

Link

https://clinicaltrials.gov/ct2/show/NCT00833989

Stichworte

Versionen (3)
  1. 04.10.19 04.10.19 -
  2. 24.10.19 24.10.19 - Sarah Riepenhausen
  3. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. Oktober 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility question
Beschreibung

Eligibility question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschreibung

If you tick no, please select all boxes in the following items corresponding to violations of any inclusion/exclusion criteria

Datentyp

text

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Have a confirmed diagnosis of stroke according to the World Health Organization definition
Beschreibung

WHO definition of stroke (1989): 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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0038454
UMLS CUI [1,3]
C0043237
Stroke onset must be within the last 24-72 hours
Beschreibung

Time of stroke onset was defined as the time at which the subject/relative was first aware of the stroke deficit. For subjects who awoke with deficits, or who were found unconscious, the time of onset was defined as the time at which they were last known to be symptom free

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0038454
UMLS CUI [1,3]
C0449244
Radiologically confirmed stroke, ischemic and supratentorial
Beschreibung

The diameter of the ischemic lesion was >15 mm in any single direction or the volume was >4cc. Note: You have to tick either this item OR the following item ("Radiologically confirmed stroke, intracerebral hemorrhage")

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043299
UMLS CUI [1,2]
C0948008
UMLS CUI [1,3]
C0441938
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
Beschreibung

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.) Note: You have to tick either this item OR the item before ("Radiologically confirmed stroke, ischemic and supratentorial")

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043299
UMLS CUI [1,2]
C0038454
UMLS CUI [1,3]
C2937358
UMLS CUI [1,4]
C0441938
UMLS CUI [1,5]
C0205125
UMLS CUI [1,6]
C1298908
UMLS CUI [1,7]
C1517569
UMLS CUI [1,8]
C0231448
UMLS CUI [2,1]
C0043299
UMLS CUI [2,2]
C0038454
UMLS CUI [2,3]
C2937358
UMLS CUI [2,4]
C0441938
UMLS CUI [2,5]
C0205125
UMLS CUI [2,6]
C0547040
UMLS CUI [2,7]
C1517569
UMLS CUI [2,8]
C0231448
Have a total NIHSS score of 3-21
Beschreibung

Based on Protocol Amendment 3, a total NIHSS score of 7-21 was used in Canada.

Datentyp

boolean

Alias
UMLS CUI [1]
C3476804
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
Beschreibung

Upper and/or lower limb deficit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3476804
UMLS CUI [1,2]
C0003794
UMLS CUI [1,3]
C2987487
UMLS CUI [2,1]
C3476804
UMLS CUI [2,2]
C0023220
UMLS CUI [2,3]
C2987487
Aged 18-90, inclusive
Beschreibung

Based on Protocol Amendment 4, the upper age range for inclusion was 85 years of age in Germany.

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits
Beschreibung

Physical, occupational and speech rehabilitation therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0949766
UMLS CUI [2]
C0037831
UMLS CUI [3]
C1318464
Reasonable likelihood of receiving both doses of investigational product
Beschreibung

Both doses of investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1706086
UMLS CUI [1,3]
C0178602
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
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030705
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1301860
UMLS CUI [2,3]
C0030701
Male subjects and females of non-child-bearing potential are allowed to participate in this study
Beschreibung

Note: Females of child-bearing potential are also allowed to participate in this study provided they are using a contraceptive method with a failure rate of <1%

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
History of a previous symptomatic stroke within 3 months prior to study entry
Beschreibung

Previous symptomic stroke

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0559159
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2348568
Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke Rankin score of >2
Beschreibung

Significant disability prior to stroke, rankin score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0038454
UMLS CUI [1,4]
C0451405
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
Beschreibung

Active and uncontrolled depression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0011581
UMLS CUI [1,3]
C0205318
Subjects who are not alert or are unresponsive
Beschreibung

defined by a score of 2 or 3 on the NIHSS Level of Consciousness question

Datentyp

boolean

Alias
UMLS CUI [1]
C0241526
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C3665546
UMLS CUI [3]
C3476804
Presence of significant aphasia as likely to confound or interfere with completion of the study assessments
Beschreibung

Significant aphasia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003537
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1516048
Presence of peripheral neuropathy, including diabetic neuropathy, which was clinically active and symptomatic at time of screening.
Beschreibung

Peripheral neuropathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231220
UMLS CUI [1,2]
C0031117
UMLS CUI [2]
C0011882
Presence of neurological or psychiatric disease, such as dementia or mild cognitive impairment, prior to study entry that is likely to confound clinical evaluations
Beschreibung

Neurological or psychiatric disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0008976
UMLS CUI [1,6]
C0679823
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1516048
UMLS CUI [2,4]
C0332152
UMLS CUI [2,5]
C0008976
UMLS CUI [2,6]
C0679823
UMLS CUI [3]
C0497327
UMLS CUI [4]
C1270972
Presence of a demyelinating disease, such as multiple sclerosis
Beschreibung

Demyelinating disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0011303
UMLS CUI [2]
C0026769
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
Beschreibung

Other chronic co-morbid conditions or unstable acute systemic illnesses

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0008679
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C2826674
UMLS CUI [1,5]
C0023671
UMLS CUI [2,1]
C0443343
UMLS CUI [2,2]
C0205178
UMLS CUI [2,3]
C0442893
UMLS CUI [2,4]
C0392760
UMLS CUI [2,5]
C2826674
UMLS CUI [2,6]
C0023671
History of sensitivity to heparin or heparin-induced thrombocytopenia
Beschreibung

Sensitivity to heparin or heparin-induced thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0019134
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0272285
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.
Beschreibung

QTcB, uncorrected QT, bundle branch block

Datentyp

boolean

Alias
UMLS CUI [1]
C1882512
UMLS CUI [2]
C1287082
UMLS CUI [3]
C0006384
Contraindication to TMS
Beschreibung

Contraindication such as: -had metal present, such as hardware or plate on the scalp in the area to which TMS was applied, implanted cardiac pacemaker, implanted prosthetic heart valve, medication pump or line, metallic implant or clip in the head/neck, electrical, mechanical or magnetic implants, neuro-stimulation device, or orthodontic work involving ferromagnetic materials -occupation or activity that could cause accidental lodging of ferromagnetic materials or embedded metal fragments in the head. Subjects could be cleared by a head computed tomography scan. -concomitant use of drugs that substantially lower seizure threshold (e.g., tricyclic antidepressants and neuroleptics) -known history of seizures or epilepsy -brain tumour, recent brain injury (within 5 years) associated with definite loss of consciousness, or any history of brain surgery -other contraindications per local hospital practice

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0436548
UMLS CUI [2,1]
C0025552
UMLS CUI [2,2]
C0460148
UMLS CUI [2,3]
C0150312
UMLS CUI [3,1]
C0028811
UMLS CUI [3,2]
C0016542
UMLS CUI [3,3]
C3178787
UMLS CUI [3,4]
C1268086
UMLS CUI [4,1]
C0441655
UMLS CUI [4,2]
C0016542
UMLS CUI [4,3]
C3178787
UMLS CUI [4,4]
C1268086
UMLS CUI [5,1]
C2347852
UMLS CUI [5,2]
C0234976
UMLS CUI [6,1]
C0262926
UMLS CUI [6,2]
C0036572
UMLS CUI [7,1]
C0262926
UMLS CUI [7,2]
C0014544
UMLS CUI [8]
C0006118
UMLS CUI [9,1]
C0332665
UMLS CUI [9,2]
C0270611
Contraindication to MRI
Beschreibung

Contraindication such as: -have metal present, such as implanted cardiac pacemaker, implanted prosthetic heart valve, medication pump or line, metallic implant or clip in the head/neck, electrical, mechanical or magnetic implants, neuro-stimulation device, or orthodontic work involving ferromagnetic materials, permanent tattooed metallic eye-liner -occupation or activity that may cause accidental lodging of ferromagnetic materials or embedded metal fragments in the head. Subjects can be cleared by a head computed tomography scan -claustrophobia -other contraindications per local hospital practice

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0025552
UMLS CUI [2,2]
C0460148
UMLS CUI [2,3]
C0150312
UMLS CUI [3,1]
C0028811
UMLS CUI [3,2]
C0016542
UMLS CUI [3,3]
C3178787
UMLS CUI [3,4]
C1268086
UMLS CUI [4,1]
C0441655
UMLS CUI [4,2]
C0016542
UMLS CUI [4,3]
C3178787
UMLS CUI [4,4]
C1268086
UMLS CUI [5]
C0008909
Participation in any investigational rehabilitation paradigm targeting stroke recovery during the duration of this study
Beschreibung

Participation in other clinical trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1517586
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C2926735
UMLS CUI [1,6]
C0008976
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)
Beschreibung

Participation in other clinical trial, investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0304229
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
Beschreibung

Sensitivity to investigational product or components thereof

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0304229
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0013227
UMLS CUI [4,1]
C0205394
UMLS CUI [4,2]
C0020517
Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test at screening or prior to dosing
Beschreibung

Pregnant females

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0042036
UMLS CUI [2,2]
C1141639
UMLS CUI [2,3]
C1446409
Lactating females
Beschreibung

Lactating females

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol
Beschreibung

Protocol compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
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Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility question
C1516637 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
Entry criteria
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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
Item
Radiologically confirmed stroke, ischemic and supratentorial
boolean
C0043299 (UMLS CUI [1,1])
C0948008 (UMLS CUI [1,2])
C0441938 (UMLS CUI [1,3])
Radiologically confirmed stroke, intracerebral hemorrhage
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
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])
NIHSS score
Item
Have a total NIHSS score of 3-21
boolean
C3476804 (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
C3476804 (UMLS CUI [1,1])
C0003794 (UMLS CUI [1,2])
C2987487 (UMLS CUI [1,3])
C3476804 (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
Item
Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits
boolean
C0949766 (UMLS CUI [1])
C0037831 (UMLS CUI [2])
C1318464 (UMLS CUI [3])
Both doses of investigational product
Item
Reasonable likelihood of receiving both doses of investigational product
boolean
C0304229 (UMLS CUI [1,1])
C1706086 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
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])
Item Group
Exclusion Criteria
C0680251 (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])
C1298908 (UMLS CUI [2,1])
C3665546 (UMLS CUI [2,2])
C3476804 (UMLS CUI [3])
Significant aphasia
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])
C1516048 (UMLS CUI [1,3])
Peripheral 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])
C1516048 (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])
C1516048 (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
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])
C0023671 (UMLS CUI [1,5])
C0443343 (UMLS CUI [2,1])
C0205178 (UMLS CUI [2,2])
C0442893 (UMLS CUI [2,3])
C0392760 (UMLS CUI [2,4])
C2826674 (UMLS CUI [2,5])
C0023671 (UMLS CUI [2,6])
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
Item
Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test at screening or prior to dosing
boolean
C0032961 (UMLS CUI [1])
C0042036 (UMLS CUI [2,1])
C1141639 (UMLS CUI [2,2])
C1446409 (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])
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