ID

23269

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. 7/1/17 7/1/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

July 1, 2017

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License

Creative Commons BY-NC 3.0
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PAN RETINAL PHOTOCOAGULATION STUDY EYE (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

English

PAN RETINAL PHOTOCOAGULATION 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
PAN RETINAL PHOTOCOAGULATION STUDY EYE (UNSCHEDULED)
Description

PAN RETINAL PHOTOCOAGULATION STUDY EYE (UNSCHEDULED)

Date Administered:
Description

TREATMENT_DT (TXDT, TXDTF)

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0730064
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]
C0730064
UMLS CUI [1,2]
C0011008
24 hr clock
# of Laser Burns:
Description

LASER_BURNS (LSRBRN)

Data type

integer

Alias
UMLS CUI [1,1]
C0332708
UMLS CUI [1,2]
C0449788
Power of the Laser:
Description

LASER_POWER (LSRPWR)

Data type

integer

Alias
UMLS CUI [1,1]
C0023089
UMLS CUI [1,2]
C3854080
Duration of Laser:
Description

LASER_DURATION (LSRDUR)

Data type

integer

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

PAN RETINAL PHOTOCOAGULATION 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
PAN RETINAL PHOTOCOAGULATION STUDY EYE (UNSCHEDULED)
TREATMENT_DT (TXDT, TXDTF)
Item
Date Administered:
date
C0730064 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TREATMENT_TIME (TXTM)
Item
Time Administered:
time
C0730064 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
LASER_BURNS (LSRBRN)
Item
# of Laser Burns:
integer
C0332708 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
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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