ID
41676
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, 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.
Palabras clave
Versiones (1)
- 12/12/20 12/12/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
12 de diciembre de 2020
DOI
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Licencia
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Ocular History and Risk Factors
- StudyEvent: ODM
Descripción
ocular history and risk factors
Alias
- UMLS CUI-1
- C1299003
- UMLS CUI-2
- C0262926
- UMLS CUI-4
- C1299003
- UMLS CUI-5
- C0035648
Descripción
patient has the following cataract risk factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C0086543
Descripción
chronic steroid use
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0281991
- UMLS CUI [1,2]
- C0205191
Descripción
family history of cataract at a young age
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0241889
- UMLS CUI [1,3]
- C1833334
Descripción
history of radiation treatment to the head or orbit
Tipo de datos
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
Descripción
diabetes mellitus
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0011849
Descripción
history of intraocular surgery
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C3282905
Descripción
history of ocular disease requiring medical treatment
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
- UMLS CUI [1,3]
- C1514873
- UMLS CUI [1,4]
- C0087111
Descripción
serious eye trauma
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205404
- UMLS CUI [1,2]
- C0015408
Descripción
chronic occupational exposure to UV light
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205191
- UMLS CUI [1,2]
- C0521127
- UMLS CUI [1,3]
- C0332157
- UMLS CUI [1,4]
- C0041625
Descripción
gout
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0018099
Descripción
cigarette use
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0694535
Descripción
alcohol abuse
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0085762
Descripción
other cataract risk factor
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0205394
Descripción
if other cataract risk factor, please specify:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
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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)
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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])