ID

38074

Description

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.

Keywords

Versions (1)
  1. 9/15/19 9/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 15, 2019

DOI

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License

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

English

Demography

12 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Center Number
Description

Center Number

Alias
UMLS CUI-1
C2347790
UMLS CUI-2
C0237753
Center Number
Description

Center Number

Data type

text

Alias
UMLS CUI [1,1]
C2347790
UMLS CUI [1,2]
C0237753
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry African American/African Heritage
Description

Geographic Ancestry African American/African Heritage

Data type

boolean

Alias
UMLS CUI [1,1]
C1517526
UMLS CUI [1,2]
C0870134
UMLS CUI [1,3]
C0085756
Geopgraphic Ancestry American Indian or Alaskan Native
Description

Geopgraphic Ancestry American Indian or Alaskan Native

Data type

boolean

Alias
UMLS CUI [1,1]
C1517526
UMLS CUI [1,2]
C0870134
UMLS CUI [1,3]
C0002460
UMLS CUI [2,1]
C1517526
UMLS CUI [2,2]
C0870134
UMLS CUI [2,3]
C0682125
Geopgraphic Ancestry Asian - Central/South Asian Heritage
Description

Geopgraphic Ancestry Asian - Central/South Asian Heritage

Data type

boolean

Alias
UMLS CUI [1,1]
C1517526
UMLS CUI [1,2]
C0870134
UMLS CUI [1,3]
C0238696
UMLS CUI [2,1]
C1517526
UMLS CUI [2,2]
C0870134
UMLS CUI [2,3]
C1519427
Geopgraphic Ancestry Asian - East Asian Heritage
Description

Geopgraphic Ancestry Asian - East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1,1]
C1517526
UMLS CUI [1,2]
C0870134
UMLS CUI [1,3]
C4540996
Geopgraphic Ancestry Asian - Japanese Heritage
Description

Geopgraphic Ancestry Asian - Japanese Heritage

Data type

boolean

Alias
UMLS CUI [1,1]
C1517526
UMLS CUI [1,2]
C0870134
UMLS CUI [1,3]
C1556094
Geopgraphic Ancestry Asian - South East Asian Heritage
Description

Geopgraphic Ancestry Asian - South East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1,1]
C1517526
UMLS CUI [1,2]
C0870134
UMLS CUI [1,3]
C0238697
Geopgraphic Ancestry Native Hawaiian or Other Pacific Islander
Description

Geopgraphic Ancestry Native Hawaiian or Other Pacific Islander

Data type

boolean

Alias
UMLS CUI [1,1]
C1517526
UMLS CUI [1,2]
C0870134
UMLS CUI [1,3]
C1513907
Geopgraphic Ancestry White - Arabic/North African Heritage
Description

Geopgraphic Ancestry White - Arabic/North African Heritage

Data type

boolean

Alias
UMLS CUI [1,1]
C1517526
UMLS CUI [1,2]
C0870134
UMLS CUI [1,3]
C1561448
UMLS CUI [2,1]
C1517526
UMLS CUI [2,2]
C0870134
UMLS CUI [2,3]
C0238604
Geographic Ancestry White - White/Caucasian/European Heritage
Description

Geographic Ancestry White - White/Caucasian/European Heritage

Data type

boolean

Alias
UMLS CUI [1,1]
C1517526
UMLS CUI [1,2]
C0870134
UMLS CUI [1,3]
C0043157
UMLS CUI [2,1]
C1517526
UMLS CUI [2,2]
C0870134
UMLS CUI [2,3]
C1535514
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Similar models

Demography

12 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
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
Center Number
C2347790 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Center Number
Item
Center Number
text
C2347790 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
male (1)
CL Item
female (2)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Geographic Ancestry African American/African Heritage
Item
Geographic Ancestry African American/African Heritage
boolean
C1517526 (UMLS CUI [1,1])
C0870134 (UMLS CUI [1,2])
C0085756 (UMLS CUI [1,3])
Geopgraphic Ancestry American Indian or Alaskan Native
Item
Geopgraphic Ancestry American Indian or Alaskan Native
boolean
C1517526 (UMLS CUI [1,1])
C0870134 (UMLS CUI [1,2])
C0002460 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C0682125 (UMLS CUI [2,3])
Geopgraphic Ancestry Asian - Central/South Asian Heritage
Item
Geopgraphic Ancestry Asian - Central/South Asian Heritage
boolean
C1517526 (UMLS CUI [1,1])
C0870134 (UMLS CUI [1,2])
C0238696 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C1519427 (UMLS CUI [2,3])
Geopgraphic Ancestry Asian - East Asian Heritage
Item
Geopgraphic Ancestry Asian - East Asian Heritage
boolean
C1517526 (UMLS CUI [1,1])
C0870134 (UMLS CUI [1,2])
C4540996 (UMLS CUI [1,3])
Geopgraphic Ancestry Asian - Japanese Heritage
Item
Geopgraphic Ancestry Asian - Japanese Heritage
boolean
C1517526 (UMLS CUI [1,1])
C0870134 (UMLS CUI [1,2])
C1556094 (UMLS CUI [1,3])
Geopgraphic Ancestry Asian - South East Asian Heritage
Item
Geopgraphic Ancestry Asian - South East Asian Heritage
boolean
C1517526 (UMLS CUI [1,1])
C0870134 (UMLS CUI [1,2])
C0238697 (UMLS CUI [1,3])
Geopgraphic Ancestry Native Hawaiian or Other Pacific Islander
Item
Geopgraphic Ancestry Native Hawaiian or Other Pacific Islander
boolean
C1517526 (UMLS CUI [1,1])
C0870134 (UMLS CUI [1,2])
C1513907 (UMLS CUI [1,3])
Geopgraphic Ancestry White - Arabic/North African Heritage
Item
Geopgraphic Ancestry White - Arabic/North African Heritage
boolean
C1517526 (UMLS CUI [1,1])
C0870134 (UMLS CUI [1,2])
C1561448 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C0238604 (UMLS CUI [2,3])
Geographic Ancestry White - White/Caucasian/European Heritage
Item
Geographic Ancestry White - White/Caucasian/European Heritage
boolean
C1517526 (UMLS CUI [1,1])
C0870134 (UMLS CUI [1,2])
C0043157 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C1535514 (UMLS CUI [2,3])
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