ID

22597

Description

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

Keywords

Versions (1)
  1. 6/8/17 6/8/17 -
Copyright Holder

Genentech, Inc.

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June 8, 2017

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Creative Commons BY-NC 3.0
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DME HISTORY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

English

DME HISTORY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

1 forms  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Data type

text

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

VDT

Data type

date

Alias
UMLS CUI [1,1]
C1302584
DME HISTORY (SCREENING) Study Eye:
Description

DME HISTORY (SCREENING) Study Eye:

Is Non-Proliferative Diabetic Retinopathy (NPDR) present in the Study Eye?
Description

NPDR_PRESENT

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0004606
If Yes, Date of first known NPDR diagnosis in the Study Eye:
Description

DIAGNOSIS_DT

Data type

date

Alias
UMLS CUI [1]
C2316983
Is Clinically Significant Macular Edema (CSME) present in the Study Eye?
Description

OPHTHALMO_CSME

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0271051
If Yes, what treatments for CSME has the patient received in the Study Eye (check all that apply)?
Description

TREATMENT_CURRENT

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0271051
UMLS CUI [1,3]
C0087111
Focal / Grid laser
Description

TREATMENT_CURRENT [TXCR1]

Data type

boolean

Alias
UMLS CUI [1,1]
C2960577
Date of Last Rx:
Description

TREATMENT_DT [TXDT1]

Data type

date

Alias
UMLS CUI [1,1]
C2960577
UMLS CUI [1,2]
C0011008
Steroids (intraocular or subtenon):
Description

TREATMENT_CURRENT [TXCR2]

Data type

boolean

Alias
UMLS CUI [1]
C0149783
Date of Last Rx:
Description

TREATMENT_DT [TXCR2]

Data type

date

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0011008
Other:
Description

TREATMENT_CURRENT [TXCR3]

Data type

boolean

Alias
UMLS CUI [1]
C0418967
Other:
Description

TREATMENT_CURRENT [TXCR3]

Data type

text

Alias
UMLS CUI [1]
C0418967
Is active or previously treated proliferative diabetic retinopathy (PDR) present in the Study Eye?
Description

PDR_PRESENT

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0154830
UMLS CUI [1,3]
C2114510
If Yes, is there active neovascularization in Study Eye?
Description

NEOVASCULARIZATION

Data type

boolean

Alias
UMLS CUI [1,1]
C0035320
Did the Study Eye receive PRP laser?
Description

TX_RECEIVED [TXREC]

Data type

boolean

Alias
UMLS CUI [1]
C0730064
If Yes, date of last PRP laser in the Study Eye:
Description

DIAGNOSIS_DT [DXDT3]

Data type

date

Alias
UMLS CUI [1,1]
C0730064
UMLS CUI [1,2]
C0011008
Is there a history of Neovascular Glaucoma (NVG) in the Study Eye?
Description

NVG_PRESENT [NVGHX]

Data type

boolean

Alias
UMLS CUI [1,1]
C0017609
UMLS CUI [1,2]
C0681850
DME HISTORY (SCREENING) Fellow Eye:
Description

DME HISTORY (SCREENING) Fellow Eye:

Is Non-Proliferative Diabetic Retinopathy (NPDR) present in the Fellow Eye?
Description

NPDR_PRESENT

Data type

boolean

Alias
UMLS CUI [1,1]
C0004606
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0015392
If Yes, Date of first known NPDR diagnosis in the Fellow Eye:
Description

DIAGNOSIS_DT

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0015392
Is Clinically Significant Macular Edema (CSME) present in the Fellow Eye?
Description

OPHTHALMO_CSME

Data type

boolean

Alias
UMLS CUI [1,1]
C0271051
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0015392
If Yes, what treatments for CSME has the patient received in the Fellow Eye (check all that apply)?
Description

TREATMENT_CURRENT

Data type

boolean

Alias
UMLS CUI [1,1]
C0271051
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C3898900
UMLS CUI [1,4]
C0015392
Focal / Grid laser
Description

TREATMENT_CURRENT [TXCR1]

Data type

boolean

Alias
UMLS CUI [1,1]
C2960577
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0015392
Date of Last Rx:
Description

TREATMENT_DT [TXDT1]

Data type

date

Alias
UMLS CUI [1,1]
C2960577
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C3898900
UMLS CUI [1,4]
C0015392
Steroids (intraocular or subtenon):
Description

TREATMENT_CURRENT [TXCR2]

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0015392
Date of Last Rx:
Description

TREATMENT_DT [TXCR2]

Data type

date

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C3898900
UMLS CUI [1,4]
C0015392
Other:
Description

TREATMENT_CURRENT [TXCR3]

Data type

boolean

Alias
UMLS CUI [1,1]
C0418967
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0015392
Other:
Description

TREATMENT_CURRENT [TXCR3]

Data type

text

Alias
UMLS CUI [1,1]
C0418967
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0015392
Is active or previously treated proliferative diabetic retinopathy (PDR) present in the Fellow Eye?
Description

PDR_PRESENT

Data type

boolean

Alias
UMLS CUI [1,1]
C0154830
UMLS CUI [1,2]
C2114510
UMLS CUI [1,3]
C3898900
UMLS CUI [1,4]
C0015392
If Yes, is there active neovascularization in Fellow Eye?
Description

NEOVASCULARIZATION

Data type

boolean

Alias
UMLS CUI [1,1]
C0035320
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0015392
Did the Fellow Eye receive PRP laser?
Description

TX_RECEIVED [TXREC]

Data type

boolean

Alias
UMLS CUI [1,1]
C0730064
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0015392
If Yes, date of last PRP laser in the Fellow Eye:
Description

DIAGNOSIS_DT [DXDT3]

Data type

date

Alias
UMLS CUI [1,1]
C0730064
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C3898900
UMLS CUI [1,4]
C0015392
Is there a history of Neovascular Glaucoma (NVG) in the Fellow Eye?
Description

NVG_PRESENT [NVGHX]

Data type

boolean

Alias
UMLS CUI [1,1]
C0017609
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0015392
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Similar models

DME HISTORY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
DME HISTORY (SCREENING) Study Eye:
NPDR_PRESENT
Item
Is Non-Proliferative Diabetic Retinopathy (NPDR) present in the Study Eye?
boolean
C0681850 (UMLS CUI [1,1])
C0004606 (UMLS CUI [1,2])
DIAGNOSIS_DT
Item
If Yes, Date of first known NPDR diagnosis in the Study Eye:
date
C2316983 (UMLS CUI [1])
OPHTHALMO_CSME
Item
Is Clinically Significant Macular Edema (CSME) present in the Study Eye?
boolean
C0681850 (UMLS CUI [1,1])
C0271051 (UMLS CUI [1,2])
TREATMENT_CURRENT
Item
If Yes, what treatments for CSME has the patient received in the Study Eye (check all that apply)?
boolean
C0681850 (UMLS CUI [1,1])
C0271051 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
TREATMENT_CURRENT [TXCR1]
Item
Focal / Grid laser
boolean
C2960577 (UMLS CUI [1,1])
TREATMENT_DT [TXDT1]
Item
Date of Last Rx:
date
C2960577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TREATMENT_CURRENT [TXCR2]
Item
Steroids (intraocular or subtenon):
boolean
C0149783 (UMLS CUI [1])
TREATMENT_DT [TXCR2]
Item
Date of Last Rx:
date
C0149783 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TREATMENT_CURRENT [TXCR3]
Item
Other:
boolean
C0418967 (UMLS CUI [1])
TREATMENT_CURRENT [TXCR3]
Item
Other:
text
C0418967 (UMLS CUI [1])
PDR_PRESENT
Item
Is active or previously treated proliferative diabetic retinopathy (PDR) present in the Study Eye?
boolean
C0681850 (UMLS CUI [1,1])
C0154830 (UMLS CUI [1,2])
C2114510 (UMLS CUI [1,3])
NEOVASCULARIZATION
Item
If Yes, is there active neovascularization in Study Eye?
boolean
C0035320 (UMLS CUI [1,1])
TX_RECEIVED [TXREC]
Item
Did the Study Eye receive PRP laser?
boolean
C0730064 (UMLS CUI [1])
DIAGNOSIS_DT [DXDT3]
Item
If Yes, date of last PRP laser in the Study Eye:
date
C0730064 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
NVG_PRESENT [NVGHX]
Item
Is there a history of Neovascular Glaucoma (NVG) in the Study Eye?
boolean
C0017609 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Item Group
DME HISTORY (SCREENING) Fellow Eye:
NPDR_PRESENT
Item
Is Non-Proliferative Diabetic Retinopathy (NPDR) present in the Fellow Eye?
boolean
C0004606 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
DIAGNOSIS_DT
Item
If Yes, Date of first known NPDR diagnosis in the Fellow Eye:
date
C2316983 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
OPHTHALMO_CSME
Item
Is Clinically Significant Macular Edema (CSME) present in the Fellow Eye?
boolean
C0271051 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
TREATMENT_CURRENT
Item
If Yes, what treatments for CSME has the patient received in the Fellow Eye (check all that apply)?
boolean
C0271051 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3898900 (UMLS CUI [1,3])
C0015392 (UMLS CUI [1,4])
TREATMENT_CURRENT [TXCR1]
Item
Focal / Grid laser
boolean
C2960577 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
TREATMENT_DT [TXDT1]
Item
Date of Last Rx:
date
C2960577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C3898900 (UMLS CUI [1,3])
C0015392 (UMLS CUI [1,4])
TREATMENT_CURRENT [TXCR2]
Item
Steroids (intraocular or subtenon):
boolean
C0149783 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
TREATMENT_DT [TXCR2]
Item
Date of Last Rx:
date
C0149783 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C3898900 (UMLS CUI [1,3])
C0015392 (UMLS CUI [1,4])
TREATMENT_CURRENT [TXCR3]
Item
Other:
boolean
C0418967 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
TREATMENT_CURRENT [TXCR3]
Item
Other:
text
C0418967 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
PDR_PRESENT
Item
Is active or previously treated proliferative diabetic retinopathy (PDR) present in the Fellow Eye?
boolean
C0154830 (UMLS CUI [1,1])
C2114510 (UMLS CUI [1,2])
C3898900 (UMLS CUI [1,3])
C0015392 (UMLS CUI [1,4])
NEOVASCULARIZATION
Item
If Yes, is there active neovascularization in Fellow Eye?
boolean
C0035320 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
TX_RECEIVED [TXREC]
Item
Did the Fellow Eye receive PRP laser?
boolean
C0730064 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
DIAGNOSIS_DT [DXDT3]
Item
If Yes, date of last PRP laser in the Fellow Eye:
date
C0730064 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C3898900 (UMLS CUI [1,3])
C0015392 (UMLS CUI [1,4])
NVG_PRESENT [NVGHX]
Item
Is there a history of Neovascular Glaucoma (NVG) in the Fellow Eye?
boolean
C0017609 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
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