ID

29399

Beschreibung

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.

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Versionen (1)
  1. 21.03.18 21.03.18 -
Rechteinhaber

Roche

Hochgeladen am

21. März 2018

DOI

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Creative Commons BY-NC 3.0
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DME History Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g

Englisch

DME History Screening

1 Formulare  
  1. StudyEvent: ODM
    1. DME History Screening
DME HISTORY (SCREENING)- STUDY EYE
Beschreibung

DME HISTORY (SCREENING)- STUDY EYE

Alias
UMLS CUI-1
C0262926
Subject Number:
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschreibung

Subject Initials

Datentyp

text

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

Visit Date

Datentyp

date

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

Non-Proliferative Diabetic Retinopathy

Datentyp

boolean

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

Date of diagnosis

Datentyp

date

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

clinically significant macular edema

Datentyp

boolean

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

Date of diagnosis

Datentyp

date

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

Therapy macula edema

Datentyp

text

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

therapy end

Datentyp

date

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

Therapy macula edema

Datentyp

text

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

therapy end

Datentyp

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:
Beschreibung

other

Datentyp

text

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

proliferative diabetic retinopathy

Datentyp

boolean

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

retinal neovascularization

Datentyp

boolean

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

panretinal photocoagulation

Datentyp

boolean

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

therapy end

Datentyp

date

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

Neovascular Glaucoma

Datentyp

boolean

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

DME HISTORY (SCREENING)- FELLOW EYE

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

Non-Proliferative Diabetic Retinopathy

Datentyp

boolean

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

Date of diagnosis

Datentyp

date

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

clinically significant macular edema

Datentyp

boolean

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

Date of diagnosis

Datentyp

date

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

Therapy macula edema

Datentyp

text

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

therapy end

Datentyp

date

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

Therapy macula edema

Datentyp

text

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

therapy end

Datentyp

date

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

other

Datentyp

text

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

proliferative diabetic retinopathy

Datentyp

boolean

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

retinal neovascularization

Datentyp

boolean

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

panretinal photocoagulation

Datentyp

boolean

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

therapy end

Datentyp

date

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

Neovascular Glaucoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0017609
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Ähnliche Modelle

DME History Screening

1 Formulare
  1. StudyEvent: ODM
    1. DME History Screening
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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