ID

38268

Beschreibung

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

Stichworte

Versionen (2)
  1. 18.09.19 18.09.19 -
  2. 05.10.19 05.10.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Oktober 2019

DOI

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

Englisch

Study conclusion

1 Formulare  
  1. StudyEvent: ODM
    1. Study conclusion
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Status of treatment blind
Beschreibung

Status of treatment blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beschreibung

If you tick yes, complete the following items and the Adverse Event form and/or Investigational Product forms as appropriate.

Datentyp

text

Alias
UMLS CUI [1]
C3897431
Date blind broken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Time blind broken
Beschreibung

00:00-23:59

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0040223
Reason blind broken
Beschreibung

Reason blind broken

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
If other Reason, please specify
Beschreibung

Other Reason, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C2348235
Investigational Product discontinuation
Beschreibung

Investigational Product discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Was the investigational product stopped permanently before the scheduled end of the treatment period?
Beschreibung

If you tick yes, please complete in the following item the primary reason.

Datentyp

text

Alias
UMLS CUI [1,1]
C0444930
UMLS CUI [1,2]
C0304229
Select primary reason the investigational product was stopped
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C0304229
If other reason for stopping investigational product, please specify
Beschreibung

Other reason, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C2348235
Study conclusion
Beschreibung

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of last contact
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Beschreibung

If you tick yes, please complete details in the following items.

Datentyp

text

Alias
UMLS CUI [1]
C2349954
Case book ready for signature
Beschreibung

In the original form this item is hidden. Data owner should check the box when data cleaning is complete.

Datentyp

boolean

Alias
UMLS CUI [1]
C1519316
Date of decision to withdraw
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
Beschreibung

If you tick " Adverse Event", record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate.

Datentyp

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
If primary reason for withdrawal is Investigator discretion, please specify
Beschreibung

Withdrawal, Investigator discretion, specification

Datentyp

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
Office Use
Beschreibung

Office Use

Datentyp

text

Alias
UMLS CUI [1,1]
C0442603
UMLS CUI [1,2]
C1524063
Number of Office Use
Beschreibung

Number of Office Use

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442603
UMLS CUI [1,2]
C0237753
Death
Beschreibung

Death

Alias
UMLS CUI-1
C0011065
Is the subject alive?
Beschreibung

If you tick no, please enter the date of death and the primary cause of death in the following items.

Datentyp

text

Alias
UMLS CUI [1,1]
C2584946
UMLS CUI [1,2]
C2348568
Date of death
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Indicate the primary cause of death
Beschreibung

For both causes, please specify in the following item.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0007465
Cause of death, specification
Beschreibung

Cause of death, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0007465
Pregnancy Information
Beschreibung

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1]
C3828490
Did a female partner of the male subject become pregnant during the study?
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C3887537
UMLS CUI [1,3]
C3828490
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Ähnliche Modelle

Study conclusion

1 Formulare
  1. StudyEvent: ODM
    1. Study conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 Group
Status of treatment blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Treatment blind broken
Code List
Was the treatment blind broken during the study?
CL Item
No (N)
CL Item
Yes (Y)
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
Time blind broken
date
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (Z)
Other Reason, specification
Item
If other Reason, please specify
text
C3897431 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Investigational Product discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Item
Was the investigational product stopped permanently before the scheduled end of the treatment period?
text
C0444930 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop of investigational product
Code List
Was the investigational product stopped permanently before the scheduled end of the treatment period?
CL Item
No (N)
CL Item
Yes (Y)
Item
Select primary reason the investigational product was stopped
text
C0566251 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Primary reason for stopping investigational product
Code List
Select primary reason the investigational product was stopped
CL Item
Adverse Event (1)
CL Item
ECG abnormality (2)
CL Item
Protocol Deviation (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to Follow-up (5)
CL Item
Investigator discretion (6)
CL Item
Decision by subject or proxy (7)
CL Item
Other (8)
Other reason, specification
Item
If other reason for stopping investigational product, please specify
text
C3840932 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C2349954 (UMLS CUI [1])
Withdrawal
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes (Y)
Case book ready for signature
Item
Case book ready for signature
boolean
C1519316 (UMLS CUI [1])
Date of decision to withdraw
Item
Date of decision to withdraw
date
C2349954 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion (7)
CL Item
Withdrew consent (8)
Withdrawal, Investigator discretion, specification
Item
If primary reason for withdrawal is Investigator discretion, please specify
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C0008961 (UMLS CUI [1,5])
Item
Office Use
text
C0442603 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Pregnancy during study
Code List
Office Use
CL Item
No (N)
CL Item
Yes (Y)
Item
Number of Office Use
integer
C0442603 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Pregnancy during study
Code List
Number of Office Use
Item Group
Death
C0011065 (UMLS CUI-1)
Item
Is the subject alive?
text
C2584946 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Subject alive
Code List
Is the subject alive?
CL Item
Yes (Y)
CL Item
No (N)
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Indicate the primary cause of death
integer
C0392360 (UMLS CUI [1,1])
C0007465 (UMLS CUI [1,2])
Primary cause of death
Code List
Indicate the primary cause of death
CL Item
Events common to stroke (1)
CL Item
Other cause of death (2)
Cause of death, specification
Item
Cause of death, specification
text
C2348235 (UMLS CUI [1,1])
C0007465 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Pregnancy during study
Code List
Did the subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0086287 (UMLS CUI [1,1])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])
Pregnancy during study
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (X)
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