ID

22744

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 #: FVF4170g 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

Mots-clés

Versions (1)
  1. 11/06/2017 11/06/2017 -
Détendeur de droits

Genentech, Inc.

Téléchargé le

11 juin 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

Anglais

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

1 Formulaires  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Type de données

text

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

VDT

Type de données

date

Alias
UMLS CUI [1,1]
C1302584
CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12)
Description

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12)

Any concurrent ocular procedures performed other than FOCAL, GRID, and Pan Retinal Photocoagulation (PRP) Laser?
Description

If Yes, complete below.

Type de données

boolean

Alias
UMLS CUI [1]
C0196950
Procedure
Description

Procedure

Line Number
Description

LINE_NUMBER [LN]

Type de données

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0087111
Name of Ocular Procedure
Description

THERAPY_NAME [THPNM]

Type de données

text

Alias
UMLS CUI [1]
C0196950
Procedure Date
Description

PROCEDURE_DT [PRDT]

Type de données

date

Unités de mesure
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2584899
DD/MMM/YY
Right Eye
Description

EYE [EYE]

Type de données

boolean

Alias
UMLS CUI [1]
C0229089
Left Eye
Description

EYE [EYE]

Type de données

boolean

Alias
UMLS CUI [1]
C0229090
Disease Category Code
Description

THERAPY_TYPE [THPTYP]

Type de données

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0805701
Underlying Diagnosis / Indication
Description

DIAGNOSIS [DIAG]

Type de données

text

Alias
UMLS CUI [1]
C0011900
Procedure Outcome Stable?
Description

CLINICAL_ASSESSMENT [CLNAS]

Type de données

boolean

Alias
UMLS CUI [1]
C0205360
Retour au début de la page

Similar models

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12)
ANY_RECORDS [ANYREC]
Item
Any concurrent ocular procedures performed other than FOCAL, GRID, and Pan Retinal Photocoagulation (PRP) Laser?
boolean
C0196950 (UMLS CUI [1])
Item Group
Procedure
LINE_NUMBER [LN]
Item
Line Number
integer
C0449788 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
THERAPY_NAME [THPNM]
Item
Name of Ocular Procedure
text
C0196950 (UMLS CUI [1])
PROCEDURE_DT [PRDT]
Item
Procedure Date
date
C2584899 (UMLS CUI [1])
EYE [EYE]
Item
Right Eye
boolean
C0229089 (UMLS CUI [1])
EYE [EYE]
Item
Left Eye
boolean
C0229090 (UMLS CUI [1])
Item
Disease Category Code
integer
C0012634 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
EYE_CODE [EYECD]
Code List
Disease Category Code
CL Item
DME Related (1 )
CL Item
Cataract (including post cataract surgery) (2 )
CL Item
Glaucoma (3 )
CL Item
Vitreoretinal Disease (non-AMD) (4 )
CL Item
Diabetic Retinopathy Related (5 )
CL Item
Other (99 )
DIAGNOSIS [DIAG]
Item
Underlying Diagnosis / Indication
text
C0011900 (UMLS CUI [1])
CLINICAL_ASSESSMENT [CLNAS]
Item
Procedure Outcome Stable?
boolean
C0205360 (UMLS CUI [1])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial