ID

23204

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

  1. 6/28/17 6/28/17 -
Uploaded on

June 28, 2017

DOI

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License

Creative Commons BY-NC 3.0

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LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

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

Similar models

LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

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])
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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