ID
38268
Descripción
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 Study conclusion Form. It has to be filled in for the end of study.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Palabras clave
Versiones (2)
- 18/9/19 18/9/19 -
- 5/10/19 5/10/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
5 de octubre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
Study conclusion
- StudyEvent: ODM
Descripción
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Descripción
If you tick yes, complete the following items and the Adverse Event form and/or Investigational Product forms as appropriate.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3897431
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Descripción
00:00-23:59
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0040223
Descripción
Reason blind broken
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Descripción
Other Reason, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Descripción
Investigational Product discontinuation
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0457454
Descripción
If you tick yes, please complete in the following item the primary reason.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0444930
- UMLS CUI [1,2]
- C0304229
Descripción
Item is not required If you tick "Adverse Event", please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0444930
- UMLS CUI [1,3]
- C0304229
Descripción
Other reason, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C0444930
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C2348235
Descripción
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0805839
Descripción
If you tick yes, please complete details in the following items.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2349954
Descripción
In the original form this item is hidden. Data owner should check the box when data cleaning is complete.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519316
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0011008
Descripción
If you tick " Adverse Event", record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Descripción
Withdrawal, Investigator discretion, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008961
- UMLS CUI [1,4]
- C0022423
- UMLS CUI [1,5]
- C0008961
Descripción
Office Use
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0442603
- UMLS CUI [1,2]
- C1524063
Descripción
Number of Office Use
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0442603
- UMLS CUI [1,2]
- C0237753
Descripción
Death
Alias
- UMLS CUI-1
- C0011065
Descripción
If you tick no, please enter the date of death and the primary cause of death in the following items.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2584946
- UMLS CUI [1,2]
- C2348568
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
For both causes, please specify in the following item.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0007465
Descripción
Cause of death, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0007465
Descripción
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
This is an optional form but is conditional upon females in the trial; This form will be dynamically generated to appear at the End visit if Female is selected on the Demographics form. If Yes, complete the paper Pregnancy Notification form.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3828490
Descripción
This is an optional form, but is conditional upon males in the trial. This form will be dynamically generated if the male is selected on the Demography form. If Yes, complete the paper Pregnancy Notification form. Check "Not Applicable" if female partner not of childbearing potential or no female partner.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0086287
- UMLS CUI [1,2]
- C3887537
- UMLS CUI [1,3]
- C3828490
Similar models
Study conclusion
- StudyEvent: ODM
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0457454 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C0008961 (UMLS CUI [1,5])
C0237753 (UMLS CUI [1,2])
C0007465 (UMLS CUI [1,2])
C0007465 (UMLS CUI [1,2])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])