ID
38345
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 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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00833989
Nyckelord
Versioner (2)
- 2019-10-05 2019-10-05 -
- 2019-10-11 2019-10-11 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 oktober 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
Nerve Conduction Testing
- StudyEvent: ODM
Beskrivning
Sensory nerve testing
Alias
- UMLS CUI-1
- C0027788
- UMLS CUI-2
- C0039593
- UMLS CUI-3
- C0445254
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beskrivning
Please fill in the following items for each nerve and at each measurement.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0445254
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
- UMLS CUI [1,4]
- C0027740
Beskrivning
Please note the amplitude or tick item "Amplitude not tested".
Datatyp
float
Måttenheter
- Microvolts
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C0039593
Beskrivning
Sensory Amplitude not tested
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Beskrivning
Please note the Conduction Velocity or tick "not done" in the item "No testing".
Datatyp
float
Måttenheter
- Meters per second
Alias
- UMLS CUI [1,1]
- C0445254
- UMLS CUI [1,2]
- C0429381
Beskrivning
Sensory Conduction velocity not tested
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0436191
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Beskrivning
Please note the Sensory Action Potential or tick the item "Sensory Action Potential not tested".
Datatyp
float
Måttenheter
- Microvolts
Alias
- UMLS CUI [1]
- C0457380
Beskrivning
Sensory action potential not tested
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0457380
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0445254
- UMLS CUI [1,4]
- C3640292
Beskrivning
Sensory Nerve impression
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027740
- UMLS CUI [1,2]
- C1998467
Beskrivning
if applicable
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0027740
- UMLS CUI [1,3]
- C1998467
- UMLS CUI [1,4]
- C0566251
Beskrivning
Motor nerve testing
Alias
- UMLS CUI-1
- C0027788
- UMLS CUI-2
- C0039593
- UMLS CUI-3
- C0234130
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beskrivning
Please fill in the following items for each nerve and at each measurement.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0501384
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0039593
Beskrivning
Please note the amplitude or tick the item "Amplitude not tested".
Datatyp
float
Måttenheter
- Millivolts
Alias
- UMLS CUI [1,1]
- C0429340
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0501384
- UMLS CUI [1,4]
- C0039593
Beskrivning
Motor Amplitude not tested
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2346753
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0501384
- UMLS CUI [1,4]
- C3640292
Beskrivning
Please note the Conduction Velocity or tick the item "Conduction velocity not tested".
Datatyp
float
Måttenheter
- Meters per second
Alias
- UMLS CUI [1,1]
- C0501384
- UMLS CUI [1,2]
- C0429381
Beskrivning
Motor Conduction velocity not tested
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0436191
- UMLS CUI [1,2]
- C0027788
- UMLS CUI [1,3]
- C0501384
- UMLS CUI [1,4]
- C3640292
Beskrivning
Motor Nerve impression
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0501384
- UMLS CUI [1,2]
- C1998467
Beskrivning
if applicable
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0501384
- UMLS CUI [1,3]
- C1998467
- UMLS CUI [1,4]
- C0566251
Similar models
Nerve Conduction Testing
- StudyEvent: ODM
C0039593 (UMLS CUI-2)
C0445254 (UMLS CUI-3)
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0027740 (UMLS CUI [1,4])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C0039593 (UMLS CUI [1,4])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
C0429381 (UMLS CUI [1,2])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
C0027788 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
C1998467 (UMLS CUI [1,2])
C0027740 (UMLS CUI [1,2])
C1998467 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0039593 (UMLS CUI-2)
C0234130 (UMLS CUI-3)
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0027788 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C0027788 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,3])
C0039593 (UMLS CUI [1,4])
C0027788 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
C0429381 (UMLS CUI [1,2])
C0027788 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,3])
C3640292 (UMLS CUI [1,4])
C1998467 (UMLS CUI [1,2])
C0501384 (UMLS CUI [1,2])
C1998467 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])