ID

38343

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 Investigational Product - IV Dosing and the Randomisation form. It has to be filled in for Day 1 and Week 2.

Link

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

Keywords

Versions (2)
  1. 9/25/19 9/25/19 -
  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
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989

English

Investigational Product Dosing, Randomisation

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

Visit Type

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
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
Was the subject able to be randomised?
Description

If you tick yes, please fill in the Number and the Date of Randomisation in the following items.

Data type

text

Alias
UMLS CUI [1]
C0034656
Randomisation number
Description

Randomisation number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Investigational Product - IV Dosing
Description

Investigational Product - IV Dosing

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
Start Date of investigational Product
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Start Time of investigational Product
Description

00:00-23:59 Time is optional

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0304229
Stop Date of investigational Product
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Stop Time of investigational Product
Description

00:00-23:59 Time is optional

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0304229
Investigational product container number
Description

Investigational product container number

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Was dose interrupted?
Description

If you tick yes, please select appropriate reason in the following item.

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1512900
Reason for dose interruption
Description

Reason for dose interruption

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1512900
UMLS CUI [1,3]
C0566251
If other reason for dose interruption, please specify
Description

Other reason for dose interruption, specification

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1512900
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0566251
UMLS CUI [1,5]
C2348235
Total volume of infusion
Description

Total volume of infusion

Data type

float

Measurement units
  • ml
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C2700258
ml
Back to the top of the page

Similar models

Investigational Product Dosing, Randomisation

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
Day 1 (1)
CL Item
Week 2 (2)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Item
Was the subject able to be randomised?
text
C0034656 (UMLS CUI [1])
Randomisation
Code List
Was the subject able to be randomised?
CL Item
Yes (Y)
CL Item
No (N)
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Investigational Product - IV Dosing
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Start Date
Item
Start Date of investigational Product
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Start Time
Item
Start Time of investigational Product
time
C1301880 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date of investigational Product
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Time
Item
Stop Time of investigational Product
time
C1522314 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product container number
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Was dose interrupted?
text
C0178602 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Dose interruption
Code List
Was dose interrupted?
CL Item
No (N)
CL Item
Yes (Y)
Item
Reason for dose interruption
integer
C0178602 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Dose interruption
Code List
Reason for dose interruption
CL Item
Adverse event (1)
CL Item
Dosing Error (2)
CL Item
Subject non-compliance (3)
CL Item
Mechanical problem (4)
CL Item
Other (5)
Other reason for dose interruption, specification
Item
If other reason for dose interruption, please specify
text
C0178602 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Total volume of infusion
Item
Total volume of infusion
float
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial