ID

22589

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 #: FVF4168g 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

Palabras clave

  1. 8/6/17 8/6/17 -
  2. 8/6/17 8/6/17 -
Subido en

8 de junio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy

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CRFs Roche FVF4168G Macular Edema NCT00473330

STUDY EYE SELECTION (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

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
Eligibility Criteria
Descripción

Eligibility Criteria

Eligibility criteria met by:
Descripción

ELIGIBILITY_CRITERIA

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0015392
If Both Eyes is checked, please answer the following question: Was the eye with worse best corrected visual acuity selected as the study eye?
Descripción

EYE_PROTOCOL

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457868
UMLS CUI [1,2]
C1690532
If No, explain medical reason for selecting the better eye as the study eye:
Descripción

REASON

Tipo de datos

text

Alias
UMLS CUI [1]
C0392360

Similar models

STUDY EYE SELECTION (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

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
Eligibility Criteria
Item
Eligibility criteria met by:
integer
C0681850 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
Code List
Eligibility criteria met by:
CL Item
Yes (1)
CL Item
No  (2)
CL Item
Not Done (3)
EYE_PROTOCOL
Item
If Both Eyes is checked, please answer the following question: Was the eye with worse best corrected visual acuity selected as the study eye?
boolean
C1457868 (UMLS CUI [1,1])
C1690532 (UMLS CUI [1,2])
REASON
Item
If No, explain medical reason for selecting the better eye as the study eye:
text
C0392360 (UMLS CUI [1])

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