ID

38189

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 demography 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

Demography

1 forms  
  1. StudyEvent: ODM
    1. Demography
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
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
Demography
Description

Demography

Alias
UMLS CUI-1
C1704791
Date of birth
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

If female, please record child-bearnig potential in the following item.

Data type

text

Alias
UMLS CUI [1]
C0079399
Child-bearing potential
Description

Only in female patients.

Data type

integer

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Description

Geographic ancestry

Alias
UMLS CUI-1
C3841890
Geographic ancestry: African American/African Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0085756
UMLS CUI [3]
C0027567
Geographic ancestry: American Indian or Alaskan Native
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C1515945
Geographic ancestry: Asian - Central/South Asian Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0238696
UMLS CUI [3]
C1519427
Geographic ancestry: Asian - East Asian Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C4540996
Geographic ancestry: Asian - Japanese Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C1556094
Geographic ancestry: Asian - South East Asian Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0238697
Geographic ancestry: Native Hawaiian or Other Pacific Islander
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C1513907
Geographic ancestry: White - Arabic/North African Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0238604
UMLS CUI [3]
C2698217
Geographic ancestry: White - White/Caucasian/European Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0043157
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Similar models

Demography

1 forms
  1. StudyEvent: ODM
    1. Demography
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C1704791 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Child-bearing potential
integer
C3831118 (UMLS CUI [1])
Child-bearing potential
Code List
Child-bearing potential
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Geographic ancestry
C3841890 (UMLS CUI-1)
Geographic ancestry: African American/African Heritage
Item
Geographic ancestry: African American/African Heritage
boolean
C3841890 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
C0027567 (UMLS CUI [3])
Geographic ancestry: American Indian or Alaskan Native
Item
Geographic ancestry: American Indian or Alaskan Native
boolean
C3841890 (UMLS CUI [1])
C1515945 (UMLS CUI [2])
Geographic ancestry: Asian - Central/South Asian Heritage
Item
Geographic ancestry: Asian - Central/South Asian Heritage
boolean
C3841890 (UMLS CUI [1])
C0238696 (UMLS CUI [2])
C1519427 (UMLS CUI [3])
Geographic ancestry: Asian - East Asian Heritage
Item
Geographic ancestry: Asian - East Asian Heritage
boolean
C3841890 (UMLS CUI [1])
C4540996 (UMLS CUI [2])
Geographic ancestry: Asian - Japanese Heritage
Item
Geographic ancestry: Asian - Japanese Heritage
boolean
C3841890 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
Geographic ancestry: Asian - South East Asian Heritage
Item
Geographic ancestry: Asian - South East Asian Heritage
boolean
C3841890 (UMLS CUI [1])
C0238697 (UMLS CUI [2])
Geographic ancestry: Native Hawaiian or Other Pacific Islander
Item
Geographic ancestry: Native Hawaiian or Other Pacific Islander
boolean
C3841890 (UMLS CUI [1])
C1513907 (UMLS CUI [2])
Geographic ancestry: White - Arabic/North African Heritage
Item
Geographic ancestry: White - Arabic/North African Heritage
boolean
C3841890 (UMLS CUI [1])
C0238604 (UMLS CUI [2])
C2698217 (UMLS CUI [3])
Geographic ancestry: White - White/Caucasian/European Heritage
Item
Geographic ancestry: White - White/Caucasian/European Heritage
boolean
C3841890 (UMLS CUI [1])
C0043157 (UMLS CUI [2])
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