ID

38074

Beschrijving

Two-Part Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Oral Dosesof the Enteric-Coated Free Base Formulation of Darapladib (SB-480848) ina Dose Rising Fashion and to Evaluate the Safety, Tolerability and Pharmacokinetics of Darapladib when Co-administered with Ketoconazole in Healthy Adult Subjects. There are 4 parts to this study: Screening, Part A, Part B, and Follow-Up. Part A contains 2 Sessions per day for day 1-10, Part B contains 1 Session per day for day 1-14. Each itemgroup contains information when it should be filled out. The itemgroups of the non-serious and serious adverse event forms contain additional information on the definition of a serious/non-serious adverse event.

Trefwoorden

Versies (1)
  1. 15-09-19 15-09-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 september 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Darapladib Evaluation Case Report Form GSK LPL107988

Engels

Study Conclusion

12 Formulieren  
Administrative documentation
Beschrijving

Administrative documentation

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Pharmacogenetic Research
Beschrijving

Pharmacogenetic Research

Alias
UMLS CUI-1
C4084975
Has informed consent been obtained for PGx research?
Beschrijving

If Yes, record the date informed consent obtained for PGx research

Datatype

boolean

Alias
UMLS CUI [1,1]
C4084975
UMLS CUI [1,2]
C0021430
Date of informed consent
Beschrijving

Date of informed consent

Datatype

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
If no informed consent specified pick a reason
Beschrijving

If other please specify below

Datatype

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705492
UMLS CUI [1,3]
C0566251
Please specify the reason "other"
Beschrijving

Reason other specified

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Has a sample been collected for PGx research?
Beschrijving

If Yes, record the date sample taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C4084975
Date sample collected
Beschrijving

Date sample collected

Datatype

date

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0011008
Has subject withdrawn consent for PGx research?
Beschrijving

If Yes, record the date informed consent withdrawn for PGx research

Datatype

boolean

Alias
UMLS CUI [1,1]
C4084975
UMLS CUI [1,2]
C1707492
Date consent withdrawn
Beschrijving

Date consent withdrawn

Datatype

date

Alias
UMLS CUI [1,1]
C4084975
UMLS CUI [1,2]
C1707492
UMLS CUI [1,3]
C0011008
Has a request been made for sample destruction?
Beschrijving

Sample Destruction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686900
UMLS CUI [1,2]
C2347026
UMLS CUI [1,3]
C1948029
Request for sample destruction reason
Beschrijving

Request for sample destruction reason

Datatype

integer

Alias
UMLS CUI [1,1]
C0686900
UMLS CUI [1,2]
C2347026
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0566251
Specify reason "other"
Beschrijving

Other reason specified

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Pregnancy Information
Beschrijving

Pregnancy Information

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

If Yes, complete Pregnancy Notification form.

Datatype

integer

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

If Yes, complete Pregnancy Notification form.

Datatype

integer

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C3887537
UMLS CUI [1,3]
C3828490
Status of Treatment Blind
Beschrijving

Status of Treatment Blind

Alias
UMLS CUI-1
C0449438
UMLS CUI-2
C0150108
UMLS CUI-3
C0749659
Was the treatment blind broken during the study?
Beschrijving

If Yes, complete the following items

Datatype

boolean

Alias
UMLS CUI [1,1]
C0150108
UMLS CUI [1,2]
C0749659
UMLS CUI [1,3]
C0443289
Date and time blind broken
Beschrijving

Date and time blind broken

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0150108
UMLS CUI [1,3]
C0749659
UMLS CUI [1,4]
C0443289
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0150108
UMLS CUI [2,3]
C0749659
UMLS CUI [2,4]
C0443289
Reason blind broken
Beschrijving

If other specify in the next item. Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

Datatype

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0150108
UMLS CUI [1,3]
C0749659
UMLS CUI [1,4]
C0443289
Specify reason "other"
Beschrijving

Other reason specified

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Study Conclusion
Beschrijving

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C2603343
Date of subject completion or withdrawal
Beschrijving

Completion or withdrawal

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2348577
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0422727
Was the subject withdrawn from the study?
Beschrijving

Withdrawn

Datatype

boolean

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

Primary withdrawal reason

Datatype

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
Reason other specified
Beschrijving

Reason other specified

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
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Similar models

Study Conclusion

12 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Pharmacogenetic Research
C4084975 (UMLS CUI-1)
Informed Consent
Item
Has informed consent been obtained for PGx research?
boolean
C4084975 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Date of informed consent
Item
Date of informed consent
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If no informed consent specified pick a reason
integer
C0021430 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
No informed consent reason
Code List
If no informed consent specified pick a reason
CL Item
Subject declined  (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (3)
Reason other specified
Item
Please specify the reason "other"
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Sample Collection
Item
Has a sample been collected for PGx research?
boolean
C0200345 (UMLS CUI [1,1])
C4084975 (UMLS CUI [1,2])
Date sample collected
Item
Date sample collected
date
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Withdrawal of consent
Item
Has subject withdrawn consent for PGx research?
boolean
C4084975 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Date consent withdrawn
Item
Date consent withdrawn
date
C4084975 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Sample Destruction
Item
Has a request been made for sample destruction?
boolean
C0686900 (UMLS CUI [1,1])
C2347026 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
Item
Request for sample destruction reason
integer
C0686900 (UMLS CUI [1,1])
C2347026 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Request for sample destruction reason
Code List
Request for sample destruction reason
CL Item
Subject withdrew consent for PGx  (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Other reason specified
Item
Specify reason "other"
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
integer
C3828490 (UMLS CUI [1])
Pregnancy during study
Code List
Did the subject become pregnant during the study?
CL Item
yes (1)
CL Item
no (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item
Did a female partner of the male subject become pregnant during the study?
integer
C0086287 (UMLS CUI [1,1])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])
Partner Pregnancy during study
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (subject is female, female partner not of childbearing potential or no female partner) (3)
Item Group
Status of Treatment Blind
C0449438 (UMLS CUI-1)
C0150108 (UMLS CUI-2)
C0749659 (UMLS CUI-3)
Treatment Status Blind Broken
Item
Was the treatment blind broken during the study?
boolean
C0150108 (UMLS CUI [1,1])
C0749659 (UMLS CUI [1,2])
C0443289 (UMLS CUI [1,3])
Date and time blind broken
Item
Date and time blind broken
datetime
C0011008 (UMLS CUI [1,1])
C0150108 (UMLS CUI [1,2])
C0749659 (UMLS CUI [1,3])
C0443289 (UMLS CUI [1,4])
C0040223 (UMLS CUI [2,1])
C0150108 (UMLS CUI [2,2])
C0749659 (UMLS CUI [2,3])
C0443289 (UMLS CUI [2,4])
Item
Reason blind broken
integer
C0566251 (UMLS CUI [1,1])
C0150108 (UMLS CUI [1,2])
C0749659 (UMLS CUI [1,3])
C0443289 (UMLS CUI [1,4])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (2)
Other reason specified
Item
Specify reason "other"
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C2603343 (UMLS CUI-2)
Completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C2348577 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
Withdrawn
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Primary withdrawal reason
Code List
Primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate (2)
CL Item
Lost to follow-up (3)
CL Item
Protocol violation (4)
CL Item
Subject decided to withdraw from the study (5)
CL Item
Sponsor terminated study (6)
CL Item
Other (7)
Reason other specified
Item
Reason other specified
text
C0566251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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