Informações:
Falhas:
ID
34626
Descrição
TEST StudyStudy ID: 102863 Clinical Study ID: 102863 Study Title: A randomized, open-label, two-period, period-balanced, crossover study with three parallel groups to evaluate the relative bioavailability of single oral doses of SB 497115-GR phase III tablets [50 mg, 75 mg, 100 mg] compared to SB-497115-GR phase II tablets [25 mg and 50 mg] in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Trade Name: Eltrombopag Study Indication: Thrombocytopenia
Palavras-chave
Versões (1)
- 20/01/2019 20/01/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
20 de janeiro de 2019
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863
Similar models
Follow-Up Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Ocular Examination
C0031809 (UMLS CUI-1)
C1299003 (UMLS CUI-2)
C1299003 (UMLS CUI-2)
Visual Acuity, Right Eye
Item
Visual Acuity (Snellen Scale) - OD (right eye)
integer
C0042812 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,2])
Visual Acuity, Left eye structure
Item
Visual Acuity (Snellen Scale) - OS (left eye)
integer
C0042812 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,2])
Visual Acuity, Changed status
Item
Has there been a change in the subject’s visual acuity since the baseline assessment?
boolean
C0042812 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,2])
Visual Acuity, Changed status, Cataract
Item
If Yes, has this change been due to worsening cataract?
boolean
C0042812 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0086543 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,2])
C0086543 (UMLS CUI [1,3])
Item
Slip Lamp Examination - OD
text
C0419360 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item
Slip Lamp Examination - OS
text
C0419360 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item
Cortical slit lamp examination - OD
text
C0419360 (UMLS CUI [1,1])
C1176472 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
C1176472 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
CL Item
< 1.0 (1)
CL Item
1.0 - 1.9 (2)
CL Item
2.0 - 2.9 (3)
CL Item
3.0 - 3.9 (4)
CL Item
4.0 or worse (5)
CL Item
Aphakia or pseudophakia (6)
CL Item
Unable to evaluate (7)
Item
Cortical slit lamp examination - OS
text
C0419360 (UMLS CUI [1,1])
C1176472 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
C1176472 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
CL Item
< 1.0 (1)
CL Item
1.0 - 1.9 (2)
CL Item
2.0 - 2.9 (3)
CL Item
3.0 - 3.9 (4)
CL Item
4.0 or worse (5)
CL Item
Aphakia or pseudophakia (6)
CL Item
Unable to evaluate (7)
Item
Nuclear slit lamp examination - OD
text
C0419360 (UMLS CUI [1,1])
C0521447 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
C0521447 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
CL Item
< 1.0 (1)
CL Item
1.0 - 1.9 (2)
CL Item
2.0 - 2.9 (3)
CL Item
3.0 - 3.9 (4)
CL Item
4.0 or worse (5)
CL Item
Aphakia or pseudophakia (6)
CL Item
Unable to evaluate (7)
Item
Nuclear slit lamp examination - OS
text
C0419360 (UMLS CUI [1,1])
C0521447 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
C0521447 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
CL Item
< 1.0 (1)
CL Item
1.0 - 1.9 (2)
CL Item
2.0 - 2.9 (3)
CL Item
3.0 - 3.9 (4)
CL Item
4.0 or worse (5)
CL Item
Aphakia or pseudophakia (6)
CL Item
Unable to evaluate (7)
Item
Posterior Subcapsular slit lamp examination - OD
text
C0419360 (UMLS CUI [1,1])
C0205095 (UMLS CUI [1,2])
C0205152 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
C0205095 (UMLS CUI [1,2])
C0205152 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Code List
Posterior Subcapsular slit lamp examination - OD
CL Item
< 1.0 (1)
CL Item
1.0 - 1.9 (2)
CL Item
2.0 - 2.9 (3)
CL Item
3.0 - 3.9 (4)
CL Item
4.0 or worse (5)
CL Item
Aphakia or pseudophakia (6)
CL Item
Unable to evaluate (7)
Item
Posterior Subcapsular slit lamp examination - OS
text
C0419360 (UMLS CUI [1,1])
C0205095 (UMLS CUI [1,2])
C0205152 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
C0205095 (UMLS CUI [1,2])
C0205152 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Code List
Posterior Subcapsular slit lamp examination - OS
CL Item
< 1.0 (1)
CL Item
1.0 - 1.9 (2)
CL Item
2.0 - 2.9 (3)
CL Item
3.0 - 3.9 (4)
CL Item
4.0 or worse (5)
CL Item
Aphakia or pseudophakia (6)
CL Item
Unable to evaluate (7)
Item
Slit lamp biomicroscopy of posterior pole features for each eye - OD
text
C0419360 (UMLS CUI [1,1])
C0229092 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
C0229092 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Code List
Slit lamp biomicroscopy of posterior pole features for each eye - OD
CL Item
Normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item
Slit lamp biomicroscopy of posterior pole features for each eye - OS
text
C0419360 (UMLS CUI [1,1])
C0229092 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
C0229092 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Code List
Slit lamp biomicroscopy of posterior pole features for each eye - OS
CL Item
Normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item
Ophthalmoscopy - OD
text
C0029090 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,2])
CL Item
Normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item
Ophthalmoscopy - OD
text
C0029090 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,2])
CL Item
Normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Pregnancy Tests, Sampling, Date in time
Item
Date sample taken
date
C0032976 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Electronically transferred laboratory data (Blood) - Clinical Chemistry
C0008000 (UMLS CUI-1)
Item
Planned Relative Time
text
C0008000 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Follow-up (Follow-up)
Chemistry, Clinical; Sampling, Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Chemistry, Clinical; Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data (Blood) - Haematology
C0018941 (UMLS CUI-1)
Item
Planned Relative Time
text
C0018941 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Follow-up (Follow-up)
Hematologic tests, Sampling, Date in time
Item
Date Sample Taken
date
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematologic tests; Time
Item
Actual Time
time
C0018941 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data (Urine) - Urinalysis
C0042014 (UMLS CUI-1)
Item
Planned Relative Time
text
C0042014 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Follow-up (Follow-up)
Urinalysis, Sampling, Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis, Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])