ID

38112

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. It also contains an unscheduled 12-Lead-ECG form.

Link

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

Keywords

Versions (4)
  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

September 18, 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, 111539

English

Unscheduled Assessments, 12-Lead-ECG

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
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]
C0501384
UMLS CUI [1,3]
C0026845
UMLS CUI [1,4]
C0449820
Was an unscheduled Box and Blocks assessment performed?
Description

Box and Blocks assessment

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C3846158
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
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

QRS Duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C4072785
UMLS CUI [1,3]
C1287082
msec
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

If you tick "Abnormal - Clinically significant", please complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE.

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C1274040
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Similar models

Unscheduled Assessments, 12-Lead-ECG

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 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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
C0501384 (UMLS CUI [1,2])
C0026845 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
Unscheduled vital signs
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
C3854240 (UMLS CUI [1,1])
C3846158 (UMLS CUI [1,2])
Unscheduled vital signs
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])
Unscheduled vital signs
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])
Unscheduled vital signs
Code List
Was an unscheduled TMS peformed?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,3])
QTc Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine  (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
12 lead ECG; result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant  (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
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