ID
41727
Descripción
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.
Palabras clave
Versiones (1)
- 9/1/21 9/1/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
9 de enero de 2021
DOI
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Licencia
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Concomitant medication
- StudyEvent: ODM
Descripción
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Descripción
Sequence Number
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2348184
Descripción
(Trade Name preferred)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Descripción
Modified reported term
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826819
Descripción
GSK Drug synonym
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Descripción
GSK Drug Collection code
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Descripción
Failed coding
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Descripción
Unit Dose
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0869039
- UMLS CUI [1,2]
- C2347852
Descripción
Units of concomitant medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Descripción
Frequency of concomitant medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826654
Descripción
Route of concomitant medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826730
Descripción
Reason for Medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826696
Descripción
Start Date and Time of concomitant medication
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C1301880
- UMLS CUI [2,2]
- C2347852
Descripción
Concomitant medication prior to study
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826667
Descripción
Concomitant medication ongoing
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826666
Descripción
Concomitat medication end date and time
Tipo de datos
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])