ID
38074
Beschreibung
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.
Stichworte
Versionen (1)
- 15.09.19 15.09.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
15. September 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Darapladib Evaluation Case Report Form GSK LPL107988
Demography
Beschreibung
Center Number
Alias
- UMLS CUI-1
- C2347790
- UMLS CUI-2
- C0237753
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Sex
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Ethnicity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Geographic Ancestry African American/African Heritage
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C0085756
Beschreibung
Geopgraphic Ancestry American Indian or Alaskan Native
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C0002460
- UMLS CUI [2,1]
- C1517526
- UMLS CUI [2,2]
- C0870134
- UMLS CUI [2,3]
- C0682125
Beschreibung
Geopgraphic Ancestry Asian - Central/South Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C0238696
- UMLS CUI [2,1]
- C1517526
- UMLS CUI [2,2]
- C0870134
- UMLS CUI [2,3]
- C1519427
Beschreibung
Geopgraphic Ancestry Asian - East Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C4540996
Beschreibung
Geopgraphic Ancestry Asian - Japanese Heritage
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C1556094
Beschreibung
Geopgraphic Ancestry Asian - South East Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C0238697
Beschreibung
Geopgraphic Ancestry Native Hawaiian or Other Pacific Islander
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C1513907
Beschreibung
Geopgraphic Ancestry White - Arabic/North African Heritage
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C1561448
- UMLS CUI [2,1]
- C1517526
- UMLS CUI [2,2]
- C0870134
- UMLS CUI [2,3]
- C0238604
Beschreibung
Geographic Ancestry White - White/Caucasian/European Heritage
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1517526
- UMLS CUI [1,2]
- C0870134
- UMLS CUI [1,3]
- C0043157
- UMLS CUI [2,1]
- C1517526
- UMLS CUI [2,2]
- C0870134
- UMLS CUI [2,3]
- C1535514
Ähnliche Modelle
Demography
C0237753 (UMLS CUI [1,2])
C0870134 (UMLS CUI [1,2])
C0085756 (UMLS CUI [1,3])
C0870134 (UMLS CUI [1,2])
C0002460 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C0682125 (UMLS CUI [2,3])
C0870134 (UMLS CUI [1,2])
C0238696 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C1519427 (UMLS CUI [2,3])
C0870134 (UMLS CUI [1,2])
C4540996 (UMLS CUI [1,3])
C0870134 (UMLS CUI [1,2])
C1556094 (UMLS CUI [1,3])
C0870134 (UMLS CUI [1,2])
C0238697 (UMLS CUI [1,3])
C0870134 (UMLS CUI [1,2])
C1513907 (UMLS CUI [1,3])
C0870134 (UMLS CUI [1,2])
C1561448 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C0238604 (UMLS CUI [2,3])
C0870134 (UMLS CUI [1,2])
C0043157 (UMLS CUI [1,3])
C1517526 (UMLS CUI [2,1])
C0870134 (UMLS CUI [2,2])
C1535514 (UMLS CUI [2,3])