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

Concomitant Medication

12 Formulieren  
Administrative documentation
Beschrijving

Administrative documentation

Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Concomitant medications
Beschrijving

Concomitant medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject prior to dosing and/or during the study?
Beschrijving

If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0008976
Concomitant medications information
Beschrijving

Concomitant medications information

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1533716
Drug Name
Beschrijving

Drug Name

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0027365
Unit Dose
Beschrijving

Unit Dose

Datatype

float

Alias
UMLS CUI [1]
C2826646
Units
Beschrijving

Units

Datatype

text

Alias
UMLS CUI [1]
C2826767
Frequency
Beschrijving

Frequency

Datatype

float

Alias
UMLS CUI [1]
C2826654
Route
Beschrijving

Route of administration

Datatype

text

Alias
UMLS CUI [1]
C2826730
Reason for medication
Beschrijving

Reason for medication

Datatype

text

Alias
UMLS CUI [1]
C2826696
Start Date and Time
Beschrijving

Start Date and Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2]
C2826740
Taken prior to study
Beschrijving

Taken prior to study

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0008976
Stop Date and Time
Beschrijving

Stop Date and Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2]
C2826659
Ongoing medication?
Beschrijving

Ongoing medication

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medication

12 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative documentation
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Concomitant medications
C2347852 (UMLS CUI-1)
Concomitant medications
Item
Were any concomitant medications taken by the subject prior to dosing and/or during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2347852 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Item Group
Concomitant medications information
C2347852 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose
float
C2826646 (UMLS CUI [1])
Units
Item
Units
text
C2826767 (UMLS CUI [1])
Frequency
Item
Frequency
float
C2826654 (UMLS CUI [1])
Route of administration
Item
Route
text
C2826730 (UMLS CUI [1])
Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Start Date and Time
Item
Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C2826740 (UMLS CUI [2])
Taken prior to study
Item
Taken prior to study
boolean
C2347852 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Stop Date and Time
Item
Stop Date and Time
datetime
C2826744 (UMLS CUI [1])
C2826659 (UMLS CUI [2])
Ongoing medication
Item
Ongoing medication?
boolean
C2826666 (UMLS CUI [1])
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