ID

36945

Description

Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

Keywords

Versions (1)
  1. 6/23/19 6/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 23, 2019

DOI

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License

Creative Commons BY-NC 3.0
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The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503

English

Pregnancy Information; Study Conclusion; Investigational Comment Log; Investigator's Signature

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner ofthe male subject become pregnant during the study?
Description

If Yes, complete Pregnancy Notification form.

Data type

text

Alias
UMLS CUI [1]
C0919624
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0422727
UMLS CUI [1,3]
C1549507
Was the subject withdrawn from the study?
Description

If Yes, check one primary reason for withdrawal:

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Description

Primary reason for withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Specify Investigator diecretion
Description

Specify Investigator diecretion

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C2348235
Investigator Comment Log
Description

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number if applicable
Description

CRF page number if applicable

Data type

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Investigator Comment
Description

Investigator Comment

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
lnvestigator's signature
Description

lnvestigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
lnvestigator's name (print)
Description

lnvestigator's name (print)

Data type

text

Alias
UMLS CUI [1]
C2826892
lnvestigator's signature date
Description

lnvestigator's signature date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Pregnancy Information; Study Conclusion; Investigational Comment Log; Investigator's Signature

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner ofthe male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Did a female partner ofthe male subject become pregnant during the study?
Code List
Did a female partner ofthe male subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (subject is female, female partner not of childbearing potential or no female partner) (X)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [1,3])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse event --> Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (1)
CL Item
Protocol deviation (2)
CL Item
Subject reached protocol defined stopping criteria (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to follow-up (5)
CL Item
Investigator discretion (Only check if none of the other primary reasons are appropriate), specify (6)
CL Item
Withdrew consent (Only check if none of the other primary reasons are appropriate) (7)
Specify Investigator diecretion
Item
Specify Investigator diecretion
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number if applicable
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Investigator Comment
Item
Investigator Comment
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
lnvestigator's signature
Item
lnvestigator's signature
text
C2346576 (UMLS CUI [1])
lnvestigator's name (print)
Item
lnvestigator's name (print)
text
C2826892 (UMLS CUI [1])
lnvestigator's signature date
Item
lnvestigator's signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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