ID

38074

Descripción

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.

Palabras clave

Versiones (1)
  1. 15/9/19 15/9/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

15 de septiembre de 2019

DOI

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Licencia

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

Inglés

Investigational Product

12 formularios  
Administrative documentation
Descripción

Administrative documentation

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Randomisation Number
Descripción

Randomisation Number

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

Randomisation Number

Tipo de datos

integer

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

Date of Randomisation

Tipo de datos

date

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

Investigational Product Exposure

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

73 = Placebo 198 = SB-480848 (Darapladib)

Tipo de datos

integer

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

Date and Time of Dose

Tipo de datos

datetime

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

Dose

Tipo de datos

integer

Alias
UMLS CUI [1]
C0178602
Unit
Descripción

Unit

Tipo de datos

text

Alias
UMLS CUI [1]
C0869039
Treatment Confirmation
Descripción

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?
Descripción

If No, record reason(s)

Tipo de datos

boolean

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

No Correct Treatment reasons

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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