ID

23201

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 #: FVF4168g 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. 6/28/17 6/28/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 28, 2017

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License

Creative Commons BY-NC 3.0
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LASER ADMINISTRATION STUDY EYE (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

English

LASER ADMINISTRATION STUDY EYE (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

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
LASER ADMINISTRATION STUDY EYE
Description

LASER ADMINISTRATION STUDY EYE

Was laser administered on the study eye?
Description

TREATMENT_RECEIVED [TXREC]

Data type

boolean

Alias
UMLS CUI [1,1]
C0023087
If Yes: Date Administered:
Description

TREATMENT_DT [TXDT]

Data type

date

Alias
UMLS CUI [1,1]
C0023087
UMLS CUI [1,2]
C0011008
Time Administered:
Description

TREATMENT_TIME [TXTM]

Data type

time

Measurement units
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0023087
UMLS CUI [1,2]
C0040223
24 hr clock
What type of laser?
Description

TREATMENT_TYPE [TXTYP]

Data type

integer

Alias
UMLS CUI [1]
C0023089
# of Laser Burns:
Description

LASER_BURNS [LSRBRN]

Data type

integer

Alias
UMLS CUI [1,1]
C0332708
Power of the Laser:
Description

LASER_POWER [LSRPWR]

Data type

integer

Measurement units
  • mW
Alias
UMLS CUI [1,1]
C0023089
UMLS CUI [1,2]
C3854080
mW
Duration of Laser:
Description

LASER_DURATION [LSRDUR]

Data type

integer

Measurement units
  • seconds
Alias
UMLS CUI [1,1]
C0023089
UMLS CUI [1,2]
C0449238
seconds
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Similar models

LASER ADMINISTRATION STUDY EYE (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

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
LASER ADMINISTRATION STUDY EYE
TREATMENT_RECEIVED [TXREC]
Item
Was laser administered on the study eye?
boolean
C0023087 (UMLS CUI [1,1])
TREATMENT_DT [TXDT]
Item
If Yes: Date Administered:
date
C0023087 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TREATMENT_TIME [TXTM]
Item
Time Administered:
time
C0023087 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
What type of laser?
integer
C0023089 (UMLS CUI [1])
TREATMENT_TYPE [TXTYP]
Code List
What type of laser?
CL Item
Focal  (1)
CL Item
Grid  (2)
CL Item
Pan Retinal Photocoagulation (PRP) (3)
LASER_BURNS [LSRBRN]
Item
# of Laser Burns:
integer
C0332708 (UMLS CUI [1,1])
LASER_POWER [LSRPWR]
Item
Power of the Laser:
integer
C0023089 (UMLS CUI [1,1])
C3854080 (UMLS CUI [1,2])
LASER_DURATION [LSRDUR]
Item
Duration of Laser:
integer
C0023089 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
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