ID

23308

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

Keywords

Versions (1)
  1. 7/2/17 7/2/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

July 2, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30) CRFs Roche FVF4170G Macular Edema NCT00473382

English

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30) CRFs Roche FVF4170G Macular Edema NCT00473382

1 forms  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Data type

text

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

VDT

Data type

date

Alias
UMLS CUI [1,1]
C1302584
RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30)
Description

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30)

Eye Treated:
Description

EYE (EYE)

Data type

integer

Alias
UMLS CUI [1]
C0015392
Was treatment (Ranibizumab) administered?
Description

TX_RECEIVED (TXREC)

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1566537
Record Lot # Administered:
Description

If Yes,

Data type

text

Alias
UMLS CUI [1]
C1115660
Date Administered:
Description

TREATMENT_DATE (TXDT, TXDTF)

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1566537
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Time Administered:
Description

TIME_ADMINISTERED (TXTM)

Data type

time

Measurement units
  • 24 hr clock
Alias
UMLS CUI [1,1]
C1566537
UMLS CUI [1,2]
C0011008
24 hr clock
Was lidocaine injection administered?
Description

LIDOCAINE (LDCON)

Data type

boolean

Alias
UMLS CUI [1]
C0023660
Were preoperative antimicrobials given?
Description

ANTIBIOTICS_CURRENT (ABXCR)

Data type

boolean

Alias
UMLS CUI [1]
C0003232
Back to the top of the page

Similar models

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30) CRFs Roche FVF4170G Macular Edema NCT00473382

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30)
Item
Eye Treated:
integer
C0015392 (UMLS CUI [1])
EYE (EYE)
Code List
Eye Treated:
CL Item
Right Eye  (1)
CL Item
Left Eye  (2)
CL Item
Not Done (3)
TX_RECEIVED (TXREC)
Item
Was treatment (Ranibizumab) administered?
boolean
C0013216 (UMLS CUI [1,1])
C1566537 (UMLS CUI [1,2])
LOT (LOT)
Item
Record Lot # Administered:
text
C1115660 (UMLS CUI [1])
TREATMENT_DATE (TXDT, TXDTF)
Item
Date Administered:
date
C1566537 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TIME_ADMINISTERED (TXTM)
Item
Time Administered:
time
C1566537 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
LIDOCAINE (LDCON)
Item
Was lidocaine injection administered?
boolean
C0023660 (UMLS CUI [1])
ANTIBIOTICS_CURRENT (ABXCR)
Item
Were preoperative antimicrobials given?
boolean
C0003232 (UMLS CUI [1])
Back to the top of the page 

Help

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