ID

38526

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 Unscheduled Assessments form.

Link

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

Keywords

  1. 9/18/19 9/18/19 -
  2. 10/5/19 10/5/19 -
  3. 10/24/19 10/24/19 - Sarah Riepenhausen
  4. 10/24/19 10/24/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 24, 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

Unscheduled Assessments

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Unscheduled Assessments
Description

Unscheduled Assessments

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C3854240
Were any unscheduled Vital signs taken?
Description

Vital signs

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0518766
Was an unscheduled ECG performed?
Description

ECG

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0430456
Was an unscheduled MRI performed?
Description

MRI

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0024485
Was an unscheduled PK assessment performed?
Description

PK

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0031328
Was an unscheduled Immunogenicity assessment performed?
Description

Immunogenicity assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C3898797
Was an unscheduled Nerve Conduction assessment performed?
Description

Nerve Conduction assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0039593
Was an unscheduled Geriatric Depression assessment performed?
Description

Geriatric Depression assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0451184
Was an unscheduled NIH Stroke assessment performed?
Description

NIH Stroke assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C1697238
Was an unscheduled Barthel assessment performed?
Description

Barthel assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0451019
Was an unscheduled Montreal Cognitive assessment performed?
Description

Montreal Cognitive assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C3496286
Was an unscheduled Gait Velocity assessment performed?
Description

Gait Velocity assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0016928
UMLS CUI [1,3]
C0436191
Was an unscheduled Berg-Balance assessment performed?
Description

Berg-Balance assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C1321053
Was an unscheduled Fugl-Meyer assessment performed?
Description

Fugl-Meyer assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0234130
UMLS CUI [1,3]
C0449820
Was an unscheduled Box and Blocks assessment performed?
Description

Box and Blocks assessment

Data type

text

Alias
UMLS CUI [1,1]
C0565699
UMLS CUI [1,2]
C0039593
Was an unscheduled Grip Strength assessment performed?
Description

Grip Strength assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0429271
Was an unscheduled TMS peformed?
Description

TMS

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0436548

Similar models

Unscheduled Assessments

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 Group
Unscheduled Assessments
C0220825 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Item
Were any unscheduled Vital signs taken?
text
C3854240 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Code List
Were any unscheduled Vital signs taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled ECG performed?
text
C3854240 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Code List
Was an unscheduled ECG performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled MRI performed?
text
C3854240 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Code List
Was an unscheduled MRI performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled PK assessment performed?
text
C3854240 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Code List
Was an unscheduled PK assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled Immunogenicity assessment performed?
text
C3854240 (UMLS CUI [1,1])
C3898797 (UMLS CUI [1,2])
Code List
Was an unscheduled Immunogenicity assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled Nerve Conduction assessment performed?
text
C3854240 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Code List
Was an unscheduled Nerve Conduction assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled Geriatric Depression assessment performed?
text
C3854240 (UMLS CUI [1,1])
C0451184 (UMLS CUI [1,2])
Code List
Was an unscheduled Geriatric Depression assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled NIH Stroke assessment performed?
text
C3854240 (UMLS CUI [1,1])
C1697238 (UMLS CUI [1,2])
Code List
Was an unscheduled NIH Stroke assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled Barthel assessment performed?
text
C3854240 (UMLS CUI [1,1])
C0451019 (UMLS CUI [1,2])
Code List
Was an unscheduled Barthel assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled Montreal Cognitive assessment performed?
text
C3854240 (UMLS CUI [1,1])
C3496286 (UMLS CUI [1,2])
Code List
Was an unscheduled Montreal Cognitive assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled Gait Velocity assessment performed?
text
C3854240 (UMLS CUI [1,1])
C0016928 (UMLS CUI [1,2])
C0436191 (UMLS CUI [1,3])
Code List
Was an unscheduled Gait Velocity assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled Berg-Balance assessment performed?
text
C3854240 (UMLS CUI [1,1])
C1321053 (UMLS CUI [1,2])
Code List
Was an unscheduled Berg-Balance assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled Fugl-Meyer assessment performed?
text
C3854240 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Code List
Was an unscheduled Fugl-Meyer assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled Box and Blocks assessment performed?
text
C0565699 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
Code List
Was an unscheduled Box and Blocks assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled Grip Strength assessment performed?
text
C3854240 (UMLS CUI [1,1])
C0429271 (UMLS CUI [1,2])
Code List
Was an unscheduled Grip Strength assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was an unscheduled TMS peformed?
text
C3854240 (UMLS CUI [1,1])
C0436548 (UMLS CUI [1,2])
Code List
Was an unscheduled TMS peformed?
CL Item
Yes (Y)
CL Item
No (N)

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