ID

41689

Description

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia If any of this information changes during the course of the study, please document the new status on this form.

Keywords

Versions (1)
  1. 12/17/20 12/17/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 17, 2020

DOI

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License

Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122

English

Logs and Repeats

1 forms  
  1. StudyEvent: ODM
    1. Logs and Repeats
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Description

Date is the start of the study for this subject

Data type

date

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0808070
subject ID
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Adverse event/concomitant medication/repeat assessment check questions
Description

Adverse event/concomitant medication/repeat assessment check questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C0205341
UMLS CUI-4
C0220825
were any concomitant medications taken by the subject during the study?
Description

concomitant medications taken during study

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Did the subject experience any adverse events during the study?
Description

adverse events during study

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Were any repeat lab samples taken?
Description

repeat lab samples

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0205341
Were any repeat ECGs performed?
Description

repeat ECGs

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
Were any repeat vital signs recorded?
Description

repeat vital signs

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
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Similar models

Logs and Repeats

1 forms
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
start of the study for subject
Item
date of visit/assessment
date
C2348568 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
subject ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
Item Group
Adverse event/concomitant medication/repeat assessment check questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
concomitant medications taken during study
Item
were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
adverse events during study
Item
Did the subject experience any adverse events during the study?
boolean
C0877248 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
repeat lab samples
Item
Were any repeat lab samples taken?
boolean
C0200345 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
repeat ECGs
Item
Were any repeat ECGs performed?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
repeat vital signs
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
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