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

Serious Adverse Events

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
Serious adverse event
Beschrijving

Serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse event during the study?
Beschrijving

Serious adverse event

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C2745955
Serious adverse event list
Beschrijving

Serious adverse event list

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0745732
Event
Beschrijving

Event

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0027365
Start Date and Time
Beschrijving

Start Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C1519255
Outcome
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1274040
End Date and Time
Beschrijving

If fatal, record date/time of death.

Datatype

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1522314
UMLS CUI [2,2]
C1519255
Maximum Intensity
Beschrijving

Maximum Intensity

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522410
UMLS CUI [1,3]
C0518690
Action Taken with Investigational Product(s) as a Result of the SAE
Beschrijving

Action Taken with Investigational Product(s) as a Result of the SAE

Datatype

text

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C4688482
UMLS CUI [1,3]
C1519255
Did the subject withdraw from study as a result of this SAE?
Beschrijving

Withdrawal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C1710677
UMLS CUI [1,3]
C1519255
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Beschrijving

Relationship to Investigational Product(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332149
UMLS CUI [1,2]
C4688482
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C1519255
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Similar models

Serious Adverse Events

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
Serious adverse event
C1519255 (UMLS CUI-1)
Serious adverse event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
Item Group
Serious adverse event list
C1519255 (UMLS CUI-1)
C0745732 (UMLS CUI-2)
Event
Item
Event
text
C1519255 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Start Date and Time
Item
Start Date and Time
datetime
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Item
Outcome
integer
C1519255 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Notrecovered/Not resolved (3)
CL Item
Recovered/Resolved withsequelae (4)
CL Item
Fatal (5)
End Date and Time
Item
End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C1522410 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C1547656 (UMLS CUI [1,1])
C4688482 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Action Taken with Investigational Product(s) as a Result of the SAE
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1547656 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C0332149 (UMLS CUI [1,1])
C4688482 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
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