ID
41727
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 This form has to be filled out, if concomitant medication has been taken by subject during the study.
Keywords
Versions (1)
- 1/9/21 1/9/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 9, 2021
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Concomitant medication
- StudyEvent: ODM
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Sequence Number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
(Trade Name preferred)
Data type
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Description
Modified reported term
Data type
text
Alias
- UMLS CUI [1]
- C2826819
Description
GSK Drug synonym
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Description
GSK Drug Collection code
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Description
Failed coding
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Unit Dose
Data type
text
Alias
- UMLS CUI [1,1]
- C0869039
- UMLS CUI [1,2]
- C2347852
Description
Units of concomitant medication
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Description
Frequency of concomitant medication
Data type
text
Alias
- UMLS CUI [1]
- C2826654
Description
Route of concomitant medication
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 of concomitant medication
Data type
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C1301880
- UMLS CUI [2,2]
- C2347852
Description
Concomitant medication prior to study
Data type
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Concomitant medication ongoing
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Concomitat medication end date and time
Data type
datetime
Alias
- UMLS CUI [1]
- C2826744
- UMLS CUI [2,1]
- C2347852
- UMLS CUI [2,2]
- C1522314
Similar models
Concomitant medication
- StudyEvent: ODM
C2347852 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C2347852 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])