ID

38345

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 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

Keywords

Versions (2)
  1. 10/5/19 10/5/19 -
  2. 10/11/19 10/11/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 11, 2019

DOI

To request one please log in.

License

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

English

Nerve Conduction Testing

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

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

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
Sensory nerve testing
Description

Sensory nerve testing

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

day month year

Data type

date

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

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

Data type

integer

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

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

Data type

float

Measurement units
  • 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
Description

Sensory Amplitude not tested

Data type

boolean

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

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

Data type

float

Measurement units
  • 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
Description

Sensory Conduction velocity not tested

Data type

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
Description

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

Data type

float

Measurement units
  • Microvolts
Alias
UMLS CUI [1]
C0457380
Microvolts
Tick if Sensory action potential for sensory nerve conduction testing was not done
Description

Sensory action potential not tested

Data type

boolean

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

Sensory Nerve impression

Data type

integer

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

if applicable

Data type

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
Description

Motor nerve testing

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

day month year

Data type

date

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

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

Data type

integer

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

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

Data type

float

Measurement units
  • 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
Description

Motor Amplitude not tested

Data type

boolean

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

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

Data type

float

Measurement units
  • 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
Description

Motor Conduction velocity not tested

Data type

boolean

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

Motor Nerve impression

Data type

integer

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

if applicable

Data type

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 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
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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