ID

38112

Beskrivning

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.

Länk

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

Nyckelord

Versioner (4)
  1. 2019-09-18 2019-09-18 -
  2. 2019-10-05 2019-10-05 -
  3. 2019-10-24 2019-10-24 - Sarah Riepenhausen
  4. 2019-10-24 2019-10-24 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 september 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, 111539

Engelsk

Unscheduled Assessments, 12-Lead-ECG

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Unscheduled Assessments
Beskrivning

Unscheduled Assessments

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

Vital signs

Datatyp

text

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

ECG

Datatyp

text

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

MRI

Datatyp

text

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

PK

Datatyp

text

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

Immunogenicity assessment

Datatyp

text

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

Nerve Conduction assessment

Datatyp

text

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

Geriatric Depression assessment

Datatyp

text

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

NIH Stroke assessment

Datatyp

text

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

Barthel assessment

Datatyp

text

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

Montreal Cognitive assessment

Datatyp

text

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

Gait Velocity assessment

Datatyp

text

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

Berg-Balance assessment

Datatyp

text

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

Fugl-Meyer assessment

Datatyp

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?
Beskrivning

Box and Blocks assessment

Datatyp

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C3846158
Was an unscheduled Grip Strength assessment performed?
Beskrivning

Grip Strength assessment

Datatyp

text

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

TMS

Datatyp

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0436548
12-Lead ECG
Beskrivning

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Beskrivning

day month year

Datatyp

date

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

00:00-23:59

Datatyp

time

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

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C4072785
UMLS CUI [1,3]
C1287082
msec
QTc Interval
Beskrivning

QTc Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

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

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.

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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