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)
- 9/15/19 9/15/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 15, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Darapladib Evaluation Case Report Form GSK LPL107988
Vital Signs
Description
Vital Parameters Screening
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Visit Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Planned relative time
Data type
time
Alias
- UMLS CUI [1,1]
- C1301732
- UMLS CUI [1,2]
- C0439564
Description
Actual Time - Start
Data type
time
Alias
- UMLS CUI [1,1]
- C0237400
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0439659
Description
Actual Time - Stop
Data type
time
Alias
- UMLS CUI [1,1]
- C0237400
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0444930
Description
Blood Pressure Supine - Systolic
Data type
float
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0039155
Description
Blood Pressure Supine - Diastolic
Data type
float
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0012000
Description
Heart Rate
Data type
float
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Similar models
Vital Signs
C0439564 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
C0039155 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
C0012000 (UMLS CUI [1,3])