ID
41727
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 This form has to be filled out, if concomitant medication has been taken by subject during the study.
Nyckelord
Versioner (1)
- 2021-01-09 2021-01-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
9 januari 2021
DOI
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Licens
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Concomitant medication
- StudyEvent: ODM
Beskrivning
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Beskrivning
Modified reported term
Datatyp
text
Alias
- UMLS CUI [1]
- C2826819
Beskrivning
GSK Drug synonym
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Beskrivning
GSK Drug Collection code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Beskrivning
Failed coding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Unit Dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0869039
- UMLS CUI [1,2]
- C2347852
Beskrivning
Units of concomitant medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Beskrivning
Frequency of concomitant medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826654
Beskrivning
Route of concomitant medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826730
Beskrivning
Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826696
Beskrivning
Start Date and Time of concomitant medication
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C1301880
- UMLS CUI [2,2]
- C2347852
Beskrivning
Concomitant medication prior to study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beskrivning
Concomitant medication ongoing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Concomitat medication end date and time
Datatyp
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])