ID

38345

Descrição

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 Nerve Conduction Testing Form. It has to be filled in at Week 1, Week 4 and in case of early withdrawal. It also can be filled in unscheduled.

Link

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

Palavras-chave

Versões (2)
  1. 05/10/2019 05/10/2019 -
  2. 11/10/2019 11/10/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

11 de outubro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989

Inglês

Nerve Conduction Testing

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Descrição

Subject number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Visit Type
Descrição

Please tick for which visit you'll fill in this form.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Date of visit
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Sensory nerve testing
Descrição

Sensory nerve testing

Alias
UMLS CUI-1
C0027788
UMLS CUI-2
C0039593
UMLS CUI-3
C0445254
Actual date of assessment
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0039593
Please tick which Nerve is tested
Descrição

Please fill in the following items for each nerve and at each measurement.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0445254
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0039593
UMLS CUI [1,4]
C0027740
Amplitude
Descrição

Please note the amplitude or tick item "Amplitude not tested".

Tipo de dados

float

Unidades de medida
  • Microvolts
Alias
UMLS CUI [1,1]
C2346753
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0445254
UMLS CUI [1,4]
C0039593
Microvolts
Tick if Amplitude for sensory nerve conduction testing was not done
Descrição

Sensory Amplitude not tested

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2346753
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0445254
UMLS CUI [1,4]
C3640292
Conduction Velocity
Descrição

Please note the Conduction Velocity or tick "not done" in the item "No testing".

Tipo de dados

float

Unidades de medida
  • Meters per second
Alias
UMLS CUI [1,1]
C0445254
UMLS CUI [1,2]
C0429381
Meters per second
Tick if Conduction velocity for sensory nerve conduction testing was not done
Descrição

Sensory Conduction velocity not tested

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0436191
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0445254
UMLS CUI [1,4]
C3640292
Sensory Action Potential
Descrição

Please note the Sensory Action Potential or tick the item "Sensory Action Potential not tested".

Tipo de dados

float

Unidades de medida
  • Microvolts
Alias
UMLS CUI [1]
C0457380
Microvolts
Tick if Sensory action potential for sensory nerve conduction testing was not done
Descrição

Sensory action potential not tested

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0457380
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0445254
UMLS CUI [1,4]
C3640292
Nerve impression
Descrição

Sensory Nerve impression

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0027740
UMLS CUI [1,2]
C1998467
Abnormal nerve impression, secondary to
Descrição

if applicable

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0027740
UMLS CUI [1,3]
C1998467
UMLS CUI [1,4]
C0566251
Motor nerve testing
Descrição

Motor nerve testing

Alias
UMLS CUI-1
C0027788
UMLS CUI-2
C0039593
UMLS CUI-3
C0234130
Actual date of assessment
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0039593
Please tick which Nerve is tested
Descrição

Please fill in the following items for each nerve and at each measurement.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0501384
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0039593
Amplitude
Descrição

Please note the amplitude or tick the item "Amplitude not tested".

Tipo de dados

float

Unidades de medida
  • Millivolts
Alias
UMLS CUI [1,1]
C0429340
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0501384
UMLS CUI [1,4]
C0039593
Millivolts
Tick if Amplitude for motor nerve conduction testing was not done
Descrição

Motor Amplitude not tested

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2346753
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0501384
UMLS CUI [1,4]
C3640292
Conduction Velocity
Descrição

Please note the Conduction Velocity or tick the item "Conduction velocity not tested".

Tipo de dados

float

Unidades de medida
  • Meters per second
Alias
UMLS CUI [1,1]
C0501384
UMLS CUI [1,2]
C0429381
Meters per second
Tick if Conduction velocity for motor nerve conduction testing was not done
Descrição

Motor Conduction velocity not tested

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0436191
UMLS CUI [1,2]
C0027788
UMLS CUI [1,3]
C0501384
UMLS CUI [1,4]
C3640292
Nerve impression
Descrição

Motor Nerve impression

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0501384
UMLS CUI [1,2]
C1998467
Abnormal nerve impression, secondary to
Descrição

if applicable

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0501384
UMLS CUI [1,3]
C1998467
UMLS CUI [1,4]
C0566251
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Similar models

Nerve Conduction Testing

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
Week 1 (1)
CL Item
Week 4 (2)
CL Item
Early withdrawal (3)
CL Item
Unscheduled (4)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Sensory nerve testing
C0027788 (UMLS CUI-1)
C0039593 (UMLS CUI-2)
C0445254 (UMLS CUI-3)
Actual date of assessment
Item
Actual date of assessment
date
C2985720 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Item
Please tick which Nerve is tested
integer
C0445254 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0027740 (UMLS CUI [1,4])
Nerve tested
Code List
Please tick which Nerve is tested
CL Item
Median Nerve (1)
CL Item
Ulnar Nerve (2)
CL Item
Sural Nerve (3)
Sensory Amplitude
Item
Amplitude
float
C2346753 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C0039593 (UMLS CUI [1,4])
Sensory Amplitude not tested
Item
Tick if Amplitude for sensory nerve conduction testing was not done
boolean
C2346753 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
Sensory Conduction Velocity
Item
Conduction Velocity
float
C0445254 (UMLS CUI [1,1])
C0429381 (UMLS CUI [1,2])
Sensory Conduction velocity not tested
Item
Tick if Conduction velocity for sensory nerve conduction testing was not done
boolean
C0436191 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
Sensory Action Potential
Item
Sensory Action Potential
float
C0457380 (UMLS CUI [1])
Sensory action potential not tested
Item
Tick if Sensory action potential for sensory nerve conduction testing was not done
boolean
C0457380 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
Item
Nerve impression
integer
C0027740 (UMLS CUI [1,1])
C1998467 (UMLS CUI [1,2])
Nerve impression
Code List
Nerve impression
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Abnormal sensory nerve impression, reason
Item
Abnormal nerve impression, secondary to
text
C1704258 (UMLS CUI [1,1])
C0027740 (UMLS CUI [1,2])
C1998467 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Item Group
Motor nerve testing
C0027788 (UMLS CUI-1)
C0039593 (UMLS CUI-2)
C0234130 (UMLS CUI-3)
Actual date of assessment
Item
Actual date of assessment
date
C2985720 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Item
Please tick which Nerve is tested
integer
C0501384 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Nerve tested
Code List
Please tick which Nerve is tested
CL Item
Median Nerve (1)
CL Item
Peroneal Nerve (2)
CL Item
Tibial Nerve (3)
Motor Amplitude
Item
Amplitude
float
C0429340 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,3])
C0039593 (UMLS CUI [1,4])
Motor Amplitude not tested
Item
Tick if Amplitude for motor nerve conduction testing was not done
boolean
C2346753 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
Motor Conduction Velocity
Item
Conduction Velocity
float
C0501384 (UMLS CUI [1,1])
C0429381 (UMLS CUI [1,2])
Motor Conduction velocity not tested
Item
Tick if Conduction velocity for motor nerve conduction testing was not done
boolean
C0436191 (UMLS CUI [1,1])
C0027788 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
Item
Nerve impression
integer
C0501384 (UMLS CUI [1,1])
C1998467 (UMLS CUI [1,2])
Nerve impression
Code List
Nerve impression
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Abnormal motor nerve impression, reason
Item
Abnormal nerve impression, secondary to
text
C1704258 (UMLS CUI [1,1])
C0501384 (UMLS CUI [1,2])
C1998467 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
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