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
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License
Creative Commons BY-NC 3.0
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Darapladib Evaluation Case Report Form GSK LPL107988
Serious Adverse Events
Description
Serious adverse event
Alias
- UMLS CUI-1
- C1519255
Description
Serious adverse event list
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0745732
Description
Event
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0027365
Description
Start Date and Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1301880
- UMLS CUI [2,2]
- C1519255
Description
Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1274040
Description
If fatal, record date/time of death.
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1522314
- UMLS CUI [2,2]
- C1519255
Description
Maximum Intensity
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522410
- UMLS CUI [1,3]
- C0518690
Description
Action Taken with Investigational Product(s) as a Result of the SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C1547656
- UMLS CUI [1,2]
- C4688482
- UMLS CUI [1,3]
- C1519255
Description
Withdrawal
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1547656
- UMLS CUI [1,2]
- C1710677
- UMLS CUI [1,3]
- C1519255
Description
Relationship to Investigational Product(s)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332149
- UMLS CUI [1,2]
- C4688482
- UMLS CUI [1,3]
- C0678227
- UMLS CUI [1,4]
- C1519255
Similar models
Serious Adverse Events
C0681850 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0745732 (UMLS CUI-2)
C0027365 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C1522410 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C4688482 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1710677 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C4688482 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])