Informations:
Erreur:
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.
Mots-clés
Versions (1)
- 20/03/2018 20/03/2018 -
Détendeur de droits
Roche
Téléchargé le
20 mars 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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DME History Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4168g
DME History Screening
- StudyEvent: ODM
Similar models
DME History Screening
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
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])
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])
C1403471 (UMLS CUI [1,2])
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)
(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])
C1403471 (UMLS CUI [1,2])
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)
(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])
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])
C1403471 (UMLS CUI [1,2])
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)
(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])
C1403471 (UMLS CUI [1,2])
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)
(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])