ID

38188

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 12-Lead-ECG form. It has to be filled in for: Day 1, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, early withdrawal, if necessary as unscheduled form as well as for logs/repeats.

Länk

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

Nyckelord

Versioner (1)
  1. 2019-09-25 2019-09-25 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

25 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, NCT00833989

Engelsk

12-Lead-ECG

1 Formulär  
  1. StudyEvent: ODM
    1. 12-Lead-ECG
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beskrivning

Visit Type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing Date and Time
Beskrivning

Dosing Date and Time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing time
Beskrivning

For Day 1 and Week 2 only. The time "3 hrs"only for week 2.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Dosing date
Beskrivning

day month year. For Day 1 and Week 2 only.

Datatyp

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
12-Lead-ECG
Beskrivning

12-Lead-ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Heart rate
Beskrivning

Heart rate

Datatyp

integer

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

PR Interval

Datatyp

float

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

QRS Duration

Datatyp

float

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

Uncorrected QT Interval

Datatyp

float

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

QTc Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0489625
msec
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]
C1274040
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Similar models

12-Lead-ECG

1 Formulär
  1. StudyEvent: ODM
    1. 12-Lead-ECG
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])
Date of visit
Item
Date of visit
date
C1320303 (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
Day 1 (1)
CL Item
Week 1 (2)
CL Item
Week 2 (3)
CL Item
Week 4 (4)
CL Item
Week 8 (5)
CL Item
Week 12 (6)
CL Item
Week 16 (7)
CL Item
early withdrawal (8)
CL Item
unscheduled  (9)
CL Item
logs/repeats (10)
Item Group
Dosing Date and Time
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Item
Dosing time
integer
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosing time
Code List
Dosing time
CL Item
Predose (1)
CL Item
3hrs (2)
CL Item
24 hrs (3)
Dosing date
Item
Dosing date
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
12-Lead-ECG
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
QTc Interval
Item
QTc Interval
float
C0430456 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of the ECG
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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