ID

38250

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 Magnetic Resonance Imaging form. It has to be filled in at Day 1, Week 2, Week 8 and in case of early withdrawal. It also can be filled in as unscheduled form.

Link

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

Keywords

Versions (1)
  1. 10/4/19 10/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 4, 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

Magnetic Resonance Imaging

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Date of Visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Magnetic Resonance Imaging
Description

Magnetic Resonance Imaging

Alias
UMLS CUI-1
C0024485
Has an MRI scan been carried out?
Description

If yo tick yes, please note the date of MRI in the following item.

Data type

text

Alias
UMLS CUI [1]
C0024485
Date of MRI Scan
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0011008
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Similar models

Magnetic Resonance Imaging

1 forms
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])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Day 1 (1)
CL Item
Week 2 (2)
CL Item
Week 8 (3)
CL Item
Early Withdrawal (4)
CL Item
unscheduled (5)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Magnetic Resonance Imaging
C0024485 (UMLS CUI-1)
Item
Has an MRI scan been carried out?
text
C0024485 (UMLS CUI [1])
MRI
Code List
Has an MRI scan been carried out?
CL Item
Yes (Y)
CL Item
No (N)
Date of MRI Scan
Item
Date of MRI Scan
date
C0024485 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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