ID

38190

Description

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 current stroke status form. It has to be filled in for Day 1.

Link

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

Keywords

Versions (1)
  1. 9/25/19 9/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 25, 2019

DOI

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License

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

English

Current stroke status

1 forms  
  1. StudyEvent: ODM
    1. Current stroke status
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Current Stroke
Description

Current Stroke

Alias
UMLS CUI-1
C0038454
UMLS CUI-2
C0521116
Stroke Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0011008
Stroke Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0040223
Can subject sit unsupported for 30 seconds?
Description

Sitting Balance

Data type

text

Alias
UMLS CUI [1,1]
C0277814
UMLS CUI [1,2]
C0560184
Reperfusion Therapy Type: Intravenous tPA
Description

Check all that apply for current stroke intervention

Data type

boolean

Alias
UMLS CUI [1]
C0035124
UMLS CUI [2,1]
C0348016
UMLS CUI [2,2]
C0032144
Reperfusion Therapy Type: Intra-arterial tPA
Description

Check all that apply for current stroke intervention

Data type

boolean

Alias
UMLS CUI [1]
C0035124
UMLS CUI [2,1]
C0694634
UMLS CUI [2,2]
C0032144
Reperfusion Therapy Type: Merci retrieval system
Description

Check all that apply for current stroke intervention

Data type

boolean

Alias
UMLS CUI [1]
C0035124
UMLS CUI [2,1]
C0190484
UMLS CUI [2,2]
C0443254
UMLS CUI [2,3]
C0995127
Reperfusion Therapy Type: Penumbra system
Description

Check all that apply for current stroke intervention

Data type

boolean

Alias
UMLS CUI [1]
C0035124
UMLS CUI [2,1]
C0190484
UMLS CUI [2,2]
C0349707
UMLS CUI [2,3]
C0995127
Reperfusion Therapy Type: Other
Description

Check all that apply for current stroke intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0035124
If other Reperfusion Therapy Type, please specify
Description

Other Reperfusion Therapy Type, Specification

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0035124
UMLS CUI [1,3]
C2348235
Reperfusion Therapy Type: No treatment given
Description

Check all that apply for current stroke intervention

Data type

boolean

Alias
UMLS CUI [1]
C0035124
UMLS CUI [2]
C0746919
Current Stroke Risk Factors
Description

Current Stroke Risk Factors

Alias
UMLS CUI-1
C0038454
UMLS CUI-2
C0521116
UMLS CUI-3
C0035648
Has the Subject had a previous stroke(s)?
Description

Previous stroke(s)

Data type

text

Alias
UMLS CUI [1]
C0559159
Previous transient ischemic attack(s)
Description

Previous transient ischemic attack(s)

Data type

text

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0007787
Atrial fibrilation
Description

Atrial fibrilation

Data type

text

Alias
UMLS CUI [1]
C0004238
Hypertension
Description

Hypertension

Data type

text

Alias
UMLS CUI [1]
C0020538
Diabetes
Description

Diabetes

Data type

text

Alias
UMLS CUI [1]
C0011849
Hypercholesterolemia
Description

Hypercholesterolemia

Data type

text

Alias
UMLS CUI [1]
C0020443
Current smoker
Description

(cigarette smoker only)

Data type

text

Alias
UMLS CUI [1]
C0337667
Alcohol consumption
Description

( >2 drinks/ day)

Data type

text

Alias
UMLS CUI [1]
C0001948
Previous myocardial infarction
Description

Previous myocardial infarction

Data type

text

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0027051
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Similar models

Current stroke status

1 forms
  1. StudyEvent: ODM
    1. Current stroke status
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Current Stroke
C0038454 (UMLS CUI-1)
C0521116 (UMLS CUI-2)
Stroke Date
Item
Stroke Date
date
C0038454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Stroke Time
Item
Stroke Time
time
C0038454 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Can subject sit unsupported for 30 seconds?
text
C0277814 (UMLS CUI [1,1])
C0560184 (UMLS CUI [1,2])
Sitting Balance
Code List
Can subject sit unsupported for 30 seconds?
CL Item
Yes (Y)
CL Item
No (N)
Reperfusion Therapy Type: Intravenous tPA
Item
Reperfusion Therapy Type: Intravenous tPA
boolean
C0035124 (UMLS CUI [1])
C0348016 (UMLS CUI [2,1])
C0032144 (UMLS CUI [2,2])
Reperfusion Therapy Type: Intra-arterial tPA
Item
Reperfusion Therapy Type: Intra-arterial tPA
boolean
C0035124 (UMLS CUI [1])
C0694634 (UMLS CUI [2,1])
C0032144 (UMLS CUI [2,2])
Reperfusion Therapy Type: Merci retrieval system
Item
Reperfusion Therapy Type: Merci retrieval system
boolean
C0035124 (UMLS CUI [1])
C0190484 (UMLS CUI [2,1])
C0443254 (UMLS CUI [2,2])
C0995127 (UMLS CUI [2,3])
Reperfusion Therapy Type: Penumbra system
Item
Reperfusion Therapy Type: Penumbra system
boolean
C0035124 (UMLS CUI [1])
C0190484 (UMLS CUI [2,1])
C0349707 (UMLS CUI [2,2])
C0995127 (UMLS CUI [2,3])
Reperfusion Therapy Type: Other
Item
Reperfusion Therapy Type: Other
boolean
C0205394 (UMLS CUI [1,1])
C0035124 (UMLS CUI [1,2])
Other Reperfusion Therapy Type, Specification
Item
If other Reperfusion Therapy Type, please specify
text
C0205394 (UMLS CUI [1,1])
C0035124 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Reperfusion Therapy Type: No treatment
Item
Reperfusion Therapy Type: No treatment given
boolean
C0035124 (UMLS CUI [1])
C0746919 (UMLS CUI [2])
Item Group
Current Stroke Risk Factors
C0038454 (UMLS CUI-1)
C0521116 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
Item
Has the Subject had a previous stroke(s)?
text
C0559159 (UMLS CUI [1])
Previous stroke(s)
Code List
Has the Subject had a previous stroke(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Previous transient ischemic attack(s)
text
C0205156 (UMLS CUI [1,1])
C0007787 (UMLS CUI [1,2])
Previous transient ischemic attack(s)
Code List
Previous transient ischemic attack(s)
CL Item
Yes (Y)
CL Item
No (N)
Item
Atrial fibrilation
text
C0004238 (UMLS CUI [1])
Atrial fibrilation
Code List
Atrial fibrilation
CL Item
Yes (Y)
CL Item
No (N)
Item
Hypertension
text
C0020538 (UMLS CUI [1])
Atrial fibrilation
Code List
Hypertension
CL Item
Yes (Y)
CL Item
No (N)
Item
Diabetes
text
C0011849 (UMLS CUI [1])
Atrial fibrilation
Code List
Diabetes
CL Item
Yes (Y)
CL Item
No (N)
Item
Hypercholesterolemia
text
C0020443 (UMLS CUI [1])
Atrial fibrilation
Code List
Hypercholesterolemia
CL Item
Yes (Y)
CL Item
No (N)
Item
Current smoker
text
C0337667 (UMLS CUI [1])
Atrial fibrilation
Code List
Current smoker
CL Item
Yes (Y)
CL Item
No (N)
Item
Alcohol consumption
text
C0001948 (UMLS CUI [1])
Atrial fibrilation
Code List
Alcohol consumption
CL Item
Yes (Y)
CL Item
No (N)
Item
Previous myocardial infarction
text
C0205156 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Atrial fibrilation
Code List
Previous myocardial infarction
CL Item
Yes (Y)
CL Item
No (N)
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