ID

22650

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. 08/06/2017 08/06/2017 -
Détendeur de droits

Genentech, Inc.

Téléchargé le

8 juin 2017

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Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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NON OCULAR SURGERY / PROCEDURE HISTORY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

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NON OCULAR SURGERY / PROCEDURE HISTORY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: 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
NON OCULAR SURGERY / PROCEDURE HISTORY (SCREENING)
Description

NON OCULAR SURGERY / PROCEDURE HISTORY (SCREENING)

Has the subject had any non ocular surgeries / procedures?
Description

If Yes, please record below.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0543467
Surgery
Description

Surgery

Line Number
Description

LINE_NUMBER [LN]

Type de données

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0087111
Surgery / Procedure
Description

SURGERY_DESCRIPTION [SRDES]

Type de données

text

Alias
UMLS CUI [1,1]
C0543467
Date
Description

SURGERY_DT [SRDT]

Type de données

date

Unités de mesure
  • DD/MMM/YY
Alias
UMLS CUI [1]
C1628561
DD/MMM/YY
Date Unknown
Description

SURGERY_DT_UNK [SRDTU]

Type de données

boolean

Alias
UMLS CUI [1,1]
C1628561
UMLS CUI [1,2]
C0439673
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Similar models

NON OCULAR SURGERY / PROCEDURE HISTORY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: 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
NON OCULAR SURGERY / PROCEDURE HISTORY (SCREENING)
SURGERY_RECORDS [SRREC]
Item
Has the subject had any non ocular surgeries / procedures?
boolean
C0543467 (UMLS CUI [1,1])
Item Group
Surgery
LINE_NUMBER [LN]
Item
Line Number
integer
C0449788 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
SURGERY_DESCRIPTION [SRDES]
Item
Surgery / Procedure
text
C0543467 (UMLS CUI [1,1])
SURGERY_DT [SRDT]
Item
Date
date
C1628561 (UMLS CUI [1])
SURGERY_DT_UNK [SRDTU]
Item
Date Unknown
boolean
C1628561 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
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