ID

22688

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 (2)
  1. 6/9/17 6/9/17 -
  2. 6/9/17 6/9/17 -
Uploaded on

June 9, 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 :

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

STUDY DRUG ADMINISTRATION DAY 0 CRFs Roche FVF4170G Macular Edema NCT00473382

English

STUDY DRUG ADMINISTRATION DAY 0 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
STUDY DRUG ADMINISTRATION (DAY 0)
Description

STUDY DRUG ADMINISTRATION (DAY 0)

Eye Treated:
Description

EYE [EYE]

Data type

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0229089
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0229090
Was treatment (Ranibizumab or sham procedure) administered?
Description

TREATMENT_RECEIVED [TXREC]

Data type

boolean

Alias
UMLS CUI [1]
C1725180
UMLS CUI [2]
C0032042
If Yes, Record kit # administered:
Description

KIT [KIT]

Data type

integer

Alias
UMLS CUI [1]
C2981406
Date Administered:
Description

TREATMENT_DT [TXDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Time Administered:
Description

TREATMENT_TIME [TXTM]

Data type

time

Measurement units
  • 24 hr clock
Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0040223
24 hr clock
Was lidocaine injection administered?
Description

LIDOCAINE [LDOCN]

Data type

boolean

Alias
UMLS CUI [1]
C0360095
Were preoperative antimicrobials given?
Description

ANTIBIOTICS_CURRENT [ABXCR]

Data type

boolean

Alias
UMLS CUI [1]
C0338237
If No, Was treatment held due to any of the Study Drug Dose-Holding Criteria?
Description

TX_HELD [TXHELD]

Data type

boolean

Alias
UMLS CUI [1]
C0557960
If Yes, check the corresponding event(s) for holding treatment: Intraocular inflammation
Description

TREATMENT_HELD_CRITERIA [TXHLDC1]

Data type

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0042164
Visual acuity loss
Description

TREATMENT_HELD_CRITERIA [TXHLDC2]

Data type

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0234632
Intraocular pressure (IOP)
Description

TREATMENT_HELD_CRITERIA [TXHLDC3]

Data type

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0578862
Sensory rhegmatogenous retinal break or detachment
Description

TREATMENT_HELD_CRITERIA [TXHLDC4]

Data type

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C2880797
Local or systemic infection
Description

TREATMENT_HELD_CRITERIA [TXHLDC5]

Data type

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C3714514
Intraocular surgery
Description

TREATMENT_HELD_CRITERIA [TXHLDC6]

Data type

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0038901
Other:
Description

TREATMENT_HELD_CRITERIA [TXHLDC7]

Data type

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
Other:
Description

OTHER_SPECIFY (OTHSP)

Data type

text

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
Back to the top of the page

Similar models

STUDY DRUG ADMINISTRATION DAY 0 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
STUDY DRUG ADMINISTRATION (DAY 0)
Item
Eye Treated:
integer
C0087111 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0229090 (UMLS CUI [2,2])
EYE [EYE]
Code List
Eye Treated:
CL Item
Right Eye  (1)
CL Item
Left Eye (2)
TREATMENT_RECEIVED [TXREC]
Item
Was treatment (Ranibizumab or sham procedure) administered?
boolean
C1725180 (UMLS CUI [1])
C0032042 (UMLS CUI [2])
KIT [KIT]
Item
If Yes, Record kit # administered:
integer
C2981406 (UMLS CUI [1])
TREATMENT_DT [TXDT]
Item
Date Administered:
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TREATMENT_TIME [TXTM]
Item
Time Administered:
time
C1533734 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
LIDOCAINE [LDOCN]
Item
Was lidocaine injection administered?
boolean
C0360095 (UMLS CUI [1])
ANTIBIOTICS_CURRENT [ABXCR]
Item
Were preoperative antimicrobials given?
boolean
C0338237 (UMLS CUI [1])
TX_HELD [TXHELD]
Item
If No, Was treatment held due to any of the Study Drug Dose-Holding Criteria?
boolean
C0557960 (UMLS CUI [1])
TREATMENT_HELD_CRITERIA [TXHLDC1]
Item
If Yes, check the corresponding event(s) for holding treatment: Intraocular inflammation
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0042164 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC2]
Item
Visual acuity loss
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0234632 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC3]
Item
Intraocular pressure (IOP)
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0578862 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC4]
Item
Sensory rhegmatogenous retinal break or detachment
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C2880797 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC5]
Item
Local or systemic infection
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC6]
Item
Intraocular surgery
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0038901 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC7]
Item
Other:
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
OTHER_SPECIFY (OTHSP)
Item
Other:
text
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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