ID

29365

Description

Study part: DME History Screening. 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. 3/20/18 3/20/18 -
Copyright Holder

Roche

Uploaded on

March 20, 2018

DOI

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License

Creative Commons BY-NC 3.0
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DME History Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4168g

English

DME History Screening

1 forms  
  1. StudyEvent: ODM
    1. DME History Screening
DME HISTORY (SCREENING)- STUDY EYE
Description

DME HISTORY (SCREENING)- STUDY EYE

Alias
UMLS CUI-1
C0262926
Subject Number:
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

Subject Initials

Data type

text

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

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Is Non-Proliferative Diabetic Retinopathy (NPDR) present in the Study Eye?
Description

Non-Proliferative Diabetic Retinopathy

Data type

boolean

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

Date of diagnosis

Data type

date

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

clinically significant macular edema

Data type

boolean

Alias
UMLS CUI [1]
C0730284
If Yes, date of first known CSME diagnosis in the Study Eye:
Description

Date of diagnosis

Data type

date

Alias
UMLS CUI [1]
C2316983
If Yes, what treatments for CSME has the patient received in the Study Eye (check all that apply)?
Description

Therapy macula edema

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1403471
Date of Last Rx:
Description

therapy end

Data type

date

Alias
UMLS CUI [1]
C1531784
If Yes, what treatments for CSME has the patient received in the Study Eye (check all that apply)?
Description

Therapy macula edema

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1403471
Date of Last Rx:
Description

therapy end

Data type

date

Alias
UMLS CUI [1]
C1531784
If Yes, what treatments for CSME has the patient received in the Study Eye (check all that apply)?- Other:
Description

other

Data type

text

Alias
UMLS CUI [1]
C0205394
Is active or previously treated proliferative diabetic retinopathy (PDR) present in the Study Eye?
Description

proliferative diabetic retinopathy

Data type

boolean

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

retinal neovascularization

Data type

boolean

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

panretinal photocoagulation

Data type

boolean

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

therapy end

Data type

date

Alias
UMLS CUI [1]
C1531784
Is there a history of Neovascular Glaucoma (NVG) in the Study Eye?
Description

Neovascular Glaucoma

Data type

boolean

Alias
UMLS CUI [1]
C0017609
DME HISTORY (SCREENING)- FELLOW EYE
Description

DME HISTORY (SCREENING)- FELLOW EYE

Alias
UMLS CUI-1
C0262926
Is Non-Proliferative Diabetic Retinopathy (NPDR) present in the Fellow Eye?
Description

Non-Proliferative Diabetic Retinopathy

Data type

boolean

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

Date of diagnosis

Data type

date

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

clinically significant macular edema

Data type

boolean

Alias
UMLS CUI [1]
C0730284
If Yes, date of first known CSME diagnosis in the Fellow Eye:
Description

Date of diagnosis

Data type

date

Alias
UMLS CUI [1]
C2316983
If Yes, what treatments for CSME has the patient received in the Fellow Eye (check all that apply)?
Description

Therapy macula edema

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1403471
Date of Last Rx:
Description

therapy end

Data type

date

Alias
UMLS CUI [1]
C1531784
If Yes, what treatments for CSME has the patient received in the Fellow Eye (check all that apply)?
Description

Therapy macula edema

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1403471
Date of Last Rx:
Description

therapy end

Data type

date

Alias
UMLS CUI [1]
C1531784
If Yes, what treatments for CSME has the patient received in the Fellow Eye (check all that apply)?
Description

other

Data type

text

Alias
UMLS CUI [1]
C0205394
Is active or previously treated proliferative diabetic retinopathy (PDR) present in the Fellow Eye?
Description

proliferative diabetic retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0154830
If Yes, is there active neovascularization in Fellow Eye?
Description

retinal neovascularization

Data type

boolean

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

panretinal photocoagulation

Data type

boolean

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

therapy end

Data type

date

Alias
UMLS CUI [1]
C1531784
Is there a history of Neovascular Glaucoma (NVG) in the Fellow Eye?
Description

Neovascular Glaucoma

Data type

boolean

Alias
UMLS CUI [1]
C0017609
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Similar models

DME History Screening

1 forms
  1. StudyEvent: ODM
    1. DME History Screening
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
DME HISTORY (SCREENING)- STUDY EYE
C0262926 (UMLS CUI-1)
Subject Number
Item
Subject Number:
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Visit Date
Item
Visit Date:
date
C1320303 (UMLS CUI [1])
Non-Proliferative Diabetic Retinopathy
Item
Is Non-Proliferative Diabetic Retinopathy (NPDR) present in the Study Eye?
boolean
C0004606 (UMLS CUI [1])
Date of diagnosis
Item
If Yes, Date of first known NPDR diagnosis in the Study Eye:
date
C2316983 (UMLS CUI [1])
clinically significant macular edema
Item
Is Clinically Significant Macular Edema (CSME) present in the Study Eye?
boolean
C0730284 (UMLS CUI [1])
Date of diagnosis
Item
If Yes, date of first known CSME diagnosis in the Study Eye:
date
C2316983 (UMLS CUI [1])
Item
If Yes, what treatments for CSME has the patient received in the Study Eye (check all that apply)?
text
C0087111 (UMLS CUI [1,1])
C1403471 (UMLS CUI [1,2])
Therapy macula edema
Code List
If Yes, what treatments for CSME has the patient received in the Study Eye (check all that apply)?
CL Item
Focal / Grid laser (Focal / Grid laser)
C2945648 (UMLS CUI-1)
(Comment:en)
therapy end
Item
Date of Last Rx:
date
C1531784 (UMLS CUI [1])
Item
If Yes, what treatments for CSME has the patient received in the Study Eye (check all that apply)?
text
C0087111 (UMLS CUI [1,1])
C1403471 (UMLS CUI [1,2])
Therapy macula edema
Code List
If Yes, what treatments for CSME has the patient received in the Study Eye (check all that apply)?
CL Item
Steroids (intraocular or subtenon) (Steroids (intraocular or subtenon))
C0149783 (UMLS CUI-1)
(Comment:en)
therapy end
Item
Date of Last Rx:
date
C1531784 (UMLS CUI [1])
other
Item
If Yes, what treatments for CSME has the patient received in the Study Eye (check all that apply)?- Other:
text
C0205394 (UMLS CUI [1])
proliferative diabetic retinopathy
Item
Is active or previously treated proliferative diabetic retinopathy (PDR) present in the Study Eye?
boolean
C0154830 (UMLS CUI [1])
retinal neovascularization
Item
If Yes, is there active neovascularization in Study Eye?
boolean
C0035320 (UMLS CUI [1])
panretinal photocoagulation
Item
Did the Study Eye receive PRP laser?
boolean
C0730064 (UMLS CUI [1])
therapy end
Item
If Yes, date of last PRP laser in the Study Eye:
date
C1531784 (UMLS CUI [1])
Neovascular Glaucoma
Item
Is there a history of Neovascular Glaucoma (NVG) in the Study Eye?
boolean
C0017609 (UMLS CUI [1])
Item Group
DME HISTORY (SCREENING)- FELLOW EYE
C0262926 (UMLS CUI-1)
Non-Proliferative Diabetic Retinopathy
Item
Is Non-Proliferative Diabetic Retinopathy (NPDR) present in the Fellow Eye?
boolean
C0004606 (UMLS CUI [1])
Date of diagnosis
Item
If Yes, Date of first known NPDR diagnosis in the Fellow Eye:
date
C2316983 (UMLS CUI [1])
clinically significant macular edema
Item
Is Clinically Significant Macular Edema (CSME) present in the Fellow Eye?
boolean
C0730284 (UMLS CUI [1])
Date of diagnosis
Item
If Yes, date of first known CSME diagnosis in the Fellow Eye:
date
C2316983 (UMLS CUI [1])
Item
If Yes, what treatments for CSME has the patient received in the Fellow Eye (check all that apply)?
text
C0087111 (UMLS CUI [1,1])
C1403471 (UMLS CUI [1,2])
Therapy macula edema
Code List
If Yes, what treatments for CSME has the patient received in the Fellow Eye (check all that apply)?
CL Item
Focal / Grid laser (Focal / Grid laser)
C2945648 (UMLS CUI-1)
(Comment:en)
therapy end
Item
Date of Last Rx:
date
C1531784 (UMLS CUI [1])
Item
If Yes, what treatments for CSME has the patient received in the Fellow Eye (check all that apply)?
text
C0087111 (UMLS CUI [1,1])
C1403471 (UMLS CUI [1,2])
Therapy macula edema
Code List
If Yes, what treatments for CSME has the patient received in the Fellow Eye (check all that apply)?
CL Item
Steroids (intraocular or subtenon) (Steroids (intraocular or subtenon))
C0149783 (UMLS CUI-1)
(Comment:en)
therapy end
Item
Date of Last Rx:
date
C1531784 (UMLS CUI [1])
other
Item
If Yes, what treatments for CSME has the patient received in the Fellow Eye (check all that apply)?
text
C0205394 (UMLS CUI [1])
proliferative diabetic retinopathy
Item
Is active or previously treated proliferative diabetic retinopathy (PDR) present in the Fellow Eye?
boolean
C0154830 (UMLS CUI [1])
retinal neovascularization
Item
If Yes, is there active neovascularization in Fellow Eye?
boolean
C0035320 (UMLS CUI [1])
panretinal photocoagulation
Item
Did the Fellow Eye receive PRP laser?
boolean
C0730064 (UMLS CUI [1])
therapy end
Item
If Yes, date of last PRP laser in the Fellow Eye:
date
C1531784 (UMLS CUI [1])
Neovascular Glaucoma
Item
Is there a history of Neovascular Glaucoma (NVG) in the Fellow Eye?
boolean
C0017609 (UMLS CUI [1])
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