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

Investigational Product

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
Randomisation Number
Beschrijving

Randomisation Number

Alias
UMLS CUI-1
C3897779
UMLS CUI-2
C0237753
Randomisation Number
Beschrijving

Randomisation Number

Datatype

integer

Alias
UMLS CUI [1,1]
C3897779
UMLS CUI [1,2]
C0237753
Date of Randomisation
Beschrijving

Date of Randomisation

Datatype

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Investigational Product Exposure
Beschrijving

Investigational Product Exposure

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C4688482
Investigational Product
Beschrijving

73 = Placebo 198 = SB-480848 (Darapladib)

Datatype

integer

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C4688482
Date and Time of Dose
Beschrijving

Date and Time of Dose

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0178602
Dose
Beschrijving

Dose

Datatype

integer

Alias
UMLS CUI [1]
C0178602
Unit
Beschrijving

Unit

Datatype

text

Alias
UMLS CUI [1]
C0869039
Treatment Confirmation
Beschrijving

Treatment Confirmation

Alias
UMLS CUI-1
C0521091
UMLS CUI-2
C1533734
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschrijving

If No, record reason(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521091
UMLS CUI [1,2]
C1533734
No Correct Treatment reasons
Beschrijving

No Correct Treatment reasons

Datatype

text

Alias
UMLS CUI [1,1]
C1272707
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C0087111
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Similar models

Investigational Product

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
Randomisation Number
C3897779 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation Number
Item
Randomisation Number
integer
C3897779 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of Randomisation
Item
Date of Randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Investigational Product Exposure
C0332157 (UMLS CUI-1)
C4688482 (UMLS CUI-2)
Investigational Product
Item
Investigational Product
integer
C0332157 (UMLS CUI [1,1])
C4688482 (UMLS CUI [1,2])
Date and Time of Dose
Item
Date and Time of Dose
datetime
C0011008 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Dose
Item
Dose
integer
C0178602 (UMLS CUI [1])
Unit
Item
Unit
text
C0869039 (UMLS CUI [1])
Item Group
Treatment Confirmation
C0521091 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
Treatment Confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0521091 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
No Correct Treatment reasons
Item
No Correct Treatment reasons
text
C1272707 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
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