ID

22681

Descripción

Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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Versiones (1)
  1. 9/6/17 9/6/17 -
Titular de derechos de autor

Genentech, Inc.

Subido en

9 de junio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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INTRAOCULAR PRESSURE (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

Inglés

INTRAOCULAR PRESSURE (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

1 formularios  
Patient administration
Descripción

Patient administration

Subject Number
Descripción

PT

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Descripción

PTINIT

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Report Date:
Descripción

VDT

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1302584
INTRAOCULAR PRESSURE (DAY 0)
Descripción

INTRAOCULAR PRESSURE (DAY 0)

Pre-dose Right Eye
Descripción

INTRAOCULAR_PRESSURE [ IOP]

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229089
mmHg
Pre-dose Right Eye Not Done
Descripción

INTRAOCULAR_PRESSURE [ IOP]

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229089
Pre-dose Left Eye
Descripción

INTRAOCULAR_PRESSURE [ IOP]

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229090
mmHg
Pre-dose Left Eye Not Done
Descripción

INTRAOCULAR_PRESSURE [ IOP]

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229090
Predose Date
Descripción

EXAM_DT [EXMDT]

Tipo de datos

date

Unidades de medida
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0011008
DD/MMM/YY
Predose Actual Time
Descripción

EXAM_TIME [EXMTM]

Tipo de datos

time

Unidades de medida
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0040223
24 hr clock
Predose Method
Descripción

Method must be consistent for a subject throughout the study.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0871511
60 min post-dose Study Eye
Descripción

QV: STUDY EYE

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0681850
mmHg
60 min post-dose Study Eye Not Done
Descripción

QV: STUDY EYE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0681850
60 min post-dose Date
Descripción

EXAM_DT [EXMDT]

Tipo de datos

date

Unidades de medida
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439571
UMLS CUI [1,3]
C0011008
DD/MMM/YY
60 min post-dose Actual Time
Descripción

EXAM_TIME [EXMTM]

Tipo de datos

time

Unidades de medida
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439571
UMLS CUI [1,3]
C0040223
24 hr clock
60 min post-dose Method
Descripción

Method must be consistent for a subject throughout the study.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439571
UMLS CUI [1,3]
C0871511
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Similar models

INTRAOCULAR PRESSURE (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Patient administration
PT
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
PTINIT
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
VDT
Item
Report Date:
date
C1302584 (UMLS CUI [1,1])
Item Group
INTRAOCULAR PRESSURE (DAY 0)
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Right Eye
integer
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Right Eye Not Done
boolean
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Left Eye
integer
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Left Eye Not Done
boolean
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
EXAM_DT [EXMDT]
Item
Predose Date
date
C0430888 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
EXAM_TIME [EXMTM]
Item
Predose Actual Time
time
C0430888 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Predose Method
integer
C0430888 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0871511 (UMLS CUI [1,3])
PROCEDURE_TYPE [PRCTYP]
Code List
Predose Method
CL Item
Applanation tonometry (1)
CL Item
Non-contact tonometry (2)
CL Item
Tonopen (3)
CL Item
Pneumotonometry (4)
QV: STUDY EYE
Item
60 min post-dose Study Eye
integer
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
QV: STUDY EYE
Item
60 min post-dose Study Eye Not Done
boolean
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
EXAM_DT [EXMDT]
Item
60 min post-dose Date
date
C0430888 (UMLS CUI [1,1])
C0439571 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
EXAM_TIME [EXMTM]
Item
60 min post-dose Actual Time
time
C0430888 (UMLS CUI [1,1])
C0439571 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
60 min post-dose Method
integer
C0430888 (UMLS CUI [1,1])
C0439571 (UMLS CUI [1,2])
C0871511 (UMLS CUI [1,3])
PROCEDURE_TYPE [PRCTYP]
Code List
60 min post-dose Method
CL Item
Applanation tonometry (1)
CL Item
Non-contact tonometry (2)
CL Item
Tonopen (3)
CL Item
Pneumotonometry (4)
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