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