ID

38187

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 Vital Signs 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.

Link

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

Keywords

Versions (1)
  1. 9/25/19 9/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 25, 2019

DOI

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License

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

English

Vital Signs

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit type
Description

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

Data type

integer

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

Dosing Date and Time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing Date
Description

day month year. Only for Day 1 and Week 2.

Data type

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Dosing Time
Description

00:00-23:59 Only for Day 1 and Week 2.

Data type

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Height and Weight
Description

Height and Weight

Alias
UMLS CUI-1
C0005890
UMLS CUI-2
C0005910
Body height
Description

Data to be collected for day 1.

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Description

Data to be collected for day 1.

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Sequence Number
Description

For repeat measurements only.

Data type

integer

Alias
UMLS CUI [1]
C2348184
Time relative to Start of Infusion
Description

Note: Time "0 min" is Immediately prior to start of infusion; Time "1 hr" is immediately after infusion has stopped. Day 1 and Week 2 only; up until 1 hour post start of infusion all times for both visits, on Day 1 additionally at 2, 4, 8, 12 and 24 hours post start of infusion, in Week 2 only the 3 hours measurement in addition

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0574032
Actual Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0040223
Systolic blood pressure
Description

Vitals to be taken in supine position.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Vitals to be taken in supine position.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Vitals to be taken in supine position.

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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Similar models

Vital Signs

1 forms
  1. StudyEvent: ODM
    1. Vital Signs
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])
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)
Dosing Date
Item
Dosing Date
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Dosing Time
Item
Dosing Time
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Height and Weight
C0005890 (UMLS CUI-1)
C0005910 (UMLS CUI-2)
Height
Item
Body height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Item
Time relative to Start of Infusion
integer
C0439564 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Measure Time
Code List
Time relative to Start of Infusion
CL Item
0 min (0)
CL Item
15 min (1)
CL Item
30 min (2)
CL Item
45 min (3)
CL Item
1 hr (4)
CL Item
2 hrs (5)
CL Item
3 hrs (6)
CL Item
4 hrs (7)
CL Item
8 hrs (8)
CL Item
12 hrs (9)
CL Item
24 hrs (10)
Actual Date
Item
Actual Date
date
C0011008 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
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