ID

29797

Beschreibung

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains End of Study Record / Hospitalization and Status of Treatment Blind.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Stichworte

Versionen (1)
  1. 19.04.18 19.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

19. April 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

Englisch

End of Study Record / Hospitalization and Status of Treatment Blind

1 Formulare  
End of Study Record
Beschreibung

End of Study Record

Alias
UMLS CUI-1
C0008972
UMLS CUI-2
C0444930
Date of subject completion or discontinuation from the study
Beschreibung

Record the date of the last follow-up visit or contact. Completion of the study is defined as a subject who completes the Week 12 End of Study Visit.

Datentyp

date

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0457454
UMLS CUI [2,2]
C0011008
Did the subject become pregnant during the study?
Beschreibung

This question must be answered for all subjects. For females not of childbearing potential or males, mark NOT APPLICABLE. If no pregnancy was known before a subject was lost to follow-up, mark NO. If the subject became pregnant before either premature discontinuation from the study or completion of the study, mark YES and record details on PREGNANCY NOTIFICATION FORM.

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Did the subject discontinue the study prematurely?
Beschreibung

Premature Study Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C2348568
If yes, mark the primary reason for discontinuation
Beschreibung

If A: Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
If other reason for discontinuation, specify:
Beschreibung

Reason for discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Hospitalization Status
Beschreibung

Hospitalization Status

Alias
UMLS CUI-1
C0019993
UMLS CUI-2
C0449438
Did the subject admit or discharge from the hospital?
Beschreibung

Hospitalization

Datentyp

text

Alias
UMLS CUI [1]
C0019993
Date of Admittance 1
Beschreibung

Date of Admittance

Datentyp

date

Alias
UMLS CUI [1]
C0806429
Date of discharge 1
Beschreibung

Date of discharge

Datentyp

date

Alias
UMLS CUI [1]
C2361123
Date of Admittance 2
Beschreibung

Date of Admittance

Datentyp

date

Alias
UMLS CUI [1]
C0806429
Date of discharge 2
Beschreibung

Date of discharge

Datentyp

date

Alias
UMLS CUI [1]
C2361123
Status of Treatment Blind
Beschreibung

Status of Treatment Blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind for this subject broken during the study?
Beschreibung

If YES, check that a date and reason are present and that the appropriate NON-SERIOUS ADVERSE EVENT, SERIOUS ADVERSE EVENT, END OF STUDY RECORD, and /or INVESTIGATIONAL PRODUCT pages are completed.

Datentyp

text

Alias
UMLS CUI [1]
C3897431
If treatment blind was broken, give the date:
Beschreibung

Date of Treatment Blind breaking

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If treatment blind was broken, give a reason:
Beschreibung

Reason for Treatment Blind breaking

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If there was another reason for treatment blind breaking, specify:
Beschreibung

Other Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C3897431
Investigator's Statement
Beschreibung

Investigator's Statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
I confirm that I have carefully examined all entries on the Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
Beschreibung

Investigator's signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschreibung

Date of signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's Name (Print)
Beschreibung

Investigator's Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

End of Study Record / Hospitalization and Status of Treatment Blind

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
End of Study Record
C0008972 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Date of subject completion or discontinuation from the study
Item
Date of subject completion or discontinuation from the study
date
C2348577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0457454 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Pregnancy during study
Code List
Did the subject become pregnant during the study?
CL Item
Not applicable (X)
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the subject discontinue the study prematurely?
text
C0457454 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Premature Study Discontinuation
Code List
Did the subject discontinue the study prematurely?
CL Item
Yes (Y)
CL Item
No (N)
Item
If yes, mark the primary reason for discontinuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for discontinuation
Code List
If yes, mark the primary reason for discontinuation
CL Item
Adverse Event (A)
CL Item
Consent withdrawn (C)
CL Item
Lost to Follow up (L)
CL Item
Protocol violation (P)
CL Item
Lack of Efficacy (E)
CL Item
Other (X)
Reason for discontinuation
Item
If other reason for discontinuation, specify:
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
Hospitalization Status
C0019993 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Item
Did the subject admit or discharge from the hospital?
text
C0019993 (UMLS CUI [1])
Hospitalization
Code List
Did the subject admit or discharge from the hospital?
CL Item
Yes (Y)
CL Item
No (N)
Date of Admittance
Item
Date of Admittance 1
date
C0806429 (UMLS CUI [1])
Date of discharge
Item
Date of discharge 1
date
C2361123 (UMLS CUI [1])
Date of Admittance
Item
Date of Admittance 2
date
C0806429 (UMLS CUI [1])
Date of discharge
Item
Date of discharge 2
date
C2361123 (UMLS CUI [1])
Item Group
Status of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Item
Was the treatment blind for this subject broken during the study?
text
C3897431 (UMLS CUI [1])
Treatment Blind broken
Code List
Was the treatment blind for this subject broken during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date of Treatment Blind breaking
Item
If treatment blind was broken, give the date:
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If treatment blind was broken, give a reason:
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for Treatment Blind breaking
Code List
If treatment blind was broken, give a reason:
CL Item
Medical emergency requiring identity of investigational product for further treatment (E)
CL Item
Other (X)
Other Reason
Item
If there was another reason for treatment blind breaking, specify:
text
C3840932 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Item Group
Investigator's Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Investigator's signature
Item
I confirm that I have carefully examined all entries on the Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's Name
Item
Investigator's Name (Print)
text
C2826892 (UMLS CUI [1])
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