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.
Mots-clés
Versions (1)
- 09/01/2021 09/01/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
9 janvier 2021
DOI
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Licence
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Concomitant medication
- StudyEvent: ODM
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Sequence Number
Type de données
integer
Alias
- UMLS CUI [1]
- C2348184
Description
(Trade Name preferred)
Type de données
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Description
Modified reported term
Type de données
text
Alias
- UMLS CUI [1]
- C2826819
Description
GSK Drug synonym
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Description
GSK Drug Collection code
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Description
Failed coding
Type de données
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Unit Dose
Type de données
text
Alias
- UMLS CUI [1,1]
- C0869039
- UMLS CUI [1,2]
- C2347852
Description
Units of concomitant medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Description
Frequency of concomitant medication
Type de données
text
Alias
- UMLS CUI [1]
- C2826654
Description
Route of concomitant medication
Type de données
text
Alias
- UMLS CUI [1]
- C2826730
Description
Reason for Medication
Type de données
text
Alias
- UMLS CUI [1]
- C2826696
Description
Start Date and Time of concomitant medication
Type de données
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C1301880
- UMLS CUI [2,2]
- C2347852
Description
Concomitant medication prior to study
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Concomitant medication ongoing
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Concomitat medication end date and time
Type de données
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])