ID

41689

Beskrivning

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.

Nyckelord

Versioner (1)
  1. 2020-12-17 2020-12-17 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 december 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122

Engelsk

Logs and Repeats

1 Formulär  
  1. StudyEvent: ODM
    1. Logs and Repeats
Administrative Data
Beskrivning

Administrative Data

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

Date is the start of the study for this subject

Datatyp

date

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

subject ID

Datatyp

text

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

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?
Beskrivning

concomitant medications taken during study

Datatyp

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?
Beskrivning

adverse events during study

Datatyp

boolean

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

repeat lab samples

Datatyp

boolean

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

repeat ECGs

Datatyp

boolean

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

repeat vital signs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Tillbaka till toppen

Similar models

Logs and Repeats

1 Formulär
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial