ID
41676
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, a follow-up visit, a logs and repeats visit, a PGx visit and a visit for the common CRF. 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 at the Screening Visit.
Nyckelord
Versioner (1)
- 2020-12-12 2020-12-12 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
12 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.
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
Ocular History and Risk Factors
- StudyEvent: ODM
Beskrivning
ocular history and risk factors
Alias
- UMLS CUI-1
- C1299003
- UMLS CUI-2
- C0262926
- UMLS CUI-4
- C1299003
- UMLS CUI-5
- C0035648
Beskrivning
patient has the following cataract risk factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0086543
Beskrivning
chronic steroid use
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0281991
- UMLS CUI [1,2]
- C0205191
Beskrivning
family history of cataract at a young age
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0241889
- UMLS CUI [1,3]
- C1833334
Beskrivning
history of radiation treatment to the head or orbit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1522449
- UMLS CUI [1,3]
- C0029180
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C1522449
- UMLS CUI [2,3]
- C0018670
Beskrivning
diabetes mellitus
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011849
Beskrivning
history of intraocular surgery
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C3282905
Beskrivning
history of ocular disease requiring medical treatment
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
- UMLS CUI [1,3]
- C1514873
- UMLS CUI [1,4]
- C0087111
Beskrivning
serious eye trauma
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205404
- UMLS CUI [1,2]
- C0015408
Beskrivning
chronic occupational exposure to UV light
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205191
- UMLS CUI [1,2]
- C0521127
- UMLS CUI [1,3]
- C0332157
- UMLS CUI [1,4]
- C0041625
Beskrivning
gout
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018099
Beskrivning
cigarette use
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0694535
Beskrivning
alcohol abuse
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085762
Beskrivning
other cataract risk factor
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0205394
Beskrivning
if other cataract risk factor, please specify:
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Similar models
Ocular History and Risk Factors
- StudyEvent: ODM
C0262926 (UMLS CUI-2)
C1299003 (UMLS CUI-4)
C0035648 (UMLS CUI-5)
C0011008 (UMLS CUI [1,2])
C3665347 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0086543 (UMLS CUI-2)
C0205191 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
C1833334 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,2])
C0029180 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0018670 (UMLS CUI [2,3])
C0543467 (UMLS CUI [1,2])
C3282905 (UMLS CUI [1,3])
C0015397 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0015408 (UMLS CUI [1,2])
C0521127 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
C0041625 (UMLS CUI [1,4])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])