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
Concomitant Medication
Description
Concomitant medications
Alias
- UMLS CUI-1
- C2347852
Description
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.
Data type
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
Description
Concomitant medications information
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1533716
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0027365
Description
Unit Dose
Data type
float
Alias
- UMLS CUI [1]
- C2826646
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C2826767
Description
Frequency
Data type
float
Alias
- UMLS CUI [1]
- C2826654
Description
Route of administration
Data type
text
Alias
- UMLS CUI [1]
- C2826730
Description
Reason for medication
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
Start Date and Time
Data type
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2]
- C2826740
Description
Taken prior to study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0008976
Description
Stop Date and Time
Data type
datetime
Alias
- UMLS CUI [1]
- C2826744
- UMLS CUI [2]
- C2826659
Description
Ongoing medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Similar models
Concomitant Medication
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])
C1533716 (UMLS CUI-2)
C0027365 (UMLS CUI [1,2])
C2826740 (UMLS CUI [2])
C0332152 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2826659 (UMLS CUI [2])