ID

23204

Beschrijving

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

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Versies (1)
  1. 28-06-17 28-06-17 -
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28 juni 2017

DOI

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Creative Commons BY-NC 3.0
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LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

Engels

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

1 Formulieren  
Patient administration
Beschrijving

Patient administration

Subject Number
Beschrijving

PT

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschrijving

PTINIT

Datatype

text

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

VDT

Datatype

date

Alias
UMLS CUI [1,1]
C1302584
LASER ADMINISTRATION STUDY EYE
Beschrijving

LASER ADMINISTRATION STUDY EYE

Was laser administered on the study eye?
Beschrijving

TREATMENT_RECEIVED [TXREC]

Datatype

boolean

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

TREATMENT_DT [TXDT]

Datatype

date

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

TREATMENT_TIME [TXTM]

Datatype

time

Maateenheden
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0023087
UMLS CUI [1,2]
C0040223
24 hr clock
What type of laser?
Beschrijving

TREATMENT_TYPE [TXTYP]

Datatype

integer

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

LASER_BURNS [LSRBRN]

Datatype

integer

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

LASER_POWER [LSRPWR]

Datatype

integer

Maateenheden
  • mW
Alias
UMLS CUI [1,1]
C0023089
UMLS CUI [1,2]
C3854080
mW
Duration of Laser:
Beschrijving

LASER_DURATION [LSRDUR]

Datatype

integer

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

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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