ID

24225

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 (1)
  1. 7/27/17 7/27/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

July 27, 2017

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Creative Commons BY-NC 3.0
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RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 35) CRFs Roche FVF4170G Macular Edema NCT-Nummer NCT00473382

English

RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 35) CRFs Roche FVF4170G Macular Edema NCT-Nummer 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
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 35)
Description

RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 35)

Were protocol-specified anatomical and timeframe criteria met for the rescue laser administration in the study eye?
Description

[Central foveal thickness (CFT) is 250 μm with < 50 μm reduction from the prior month’s measurement, and laser treatment not received by the subject in the past 3 months.]

Data type

boolean

Alias
UMLS CUI [1,1]
C0743733
UMLS CUI [1,2]
C1512693
Was rescue laser treatment administered to the study eye?
Description

TX_RECEIVED (TXREC)

Data type

boolean

Alias
UMLS CUI [1]
C0743733
Date Administered:
Description

If Yes (Administered):

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0743733
UMLS CUI [1,2]
C4255413
DD/MMM/YY
Time Administered:
Description

TREATMENT_TIME (TXTM)

Data type

time

Measurement units
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0743733
UMLS CUI [1,2]
C4255413
24 hr clock
Type of Laser:
Description

TREATMENT_TYPE (TXTYP)

Data type

integer

Alias
UMLS CUI [1]
C1275681
UMLS CUI [2]
C1275682
# 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

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
undefined item
Description

If No (Not Administered): If protocol specified anatomical and timeframe criteria for the rescue laser treatment were met but the rescue laser was NOT administered, select one or more reasons below and / or provide other reasons, if applicable:

Data type

text

Treatment required is too close to the edge of the foveal avascular zone
Description

INDICATE_REASON (NDRSN1)

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C1275950
Subject had extensive, adequate prior laser and all leaking microaneurysms associated with edema seen on FA have been laser treated
Description

INDICATE_REASON (NDRSN2)

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0333101
Component of traction on OCT
Description

INDICATE_REASON (NDRSN3)

Data type

boolean

Alias
UMLS CUI [1]
C0154828
Significant non-perfusion on FA
Description

INDICATE_REASON (NDRSN4)

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C4049512
Subject refused laser treatment
Description

INDICATE_REASON (NDRSN5)

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0749657
Other (specify):
Description

INDICATE_REASON (NDRSN6)

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C3840932
Other (specify):
Description

OTHER_SPECIFY [OTHSP]

Data type

text

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C3840932
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Similar models

RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 35) CRFs Roche FVF4170G Macular Edema NCT-Nummer 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
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 35)
CRIT_NOTMET_CHAR (CRTNMC)
Item
Were protocol-specified anatomical and timeframe criteria met for the rescue laser administration in the study eye?
boolean
C0743733 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
TX_RECEIVED (TXREC)
Item
Was rescue laser treatment administered to the study eye?
boolean
C0743733 (UMLS CUI [1])
TREATMENT_DATE (TXDT, TXDTF)
Item
Date Administered:
date
C0743733 (UMLS CUI [1,1])
C4255413 (UMLS CUI [1,2])
TREATMENT_TIME (TXTM)
Item
Time Administered:
time
C0743733 (UMLS CUI [1,1])
C4255413 (UMLS CUI [1,2])
Item
Type of Laser:
integer
C1275681 (UMLS CUI [1])
C1275682 (UMLS CUI [2])
TREATMENT_TYPE (TXTYP)
Code List
Type of Laser:
CL Item
Focal  (1)
CL Item
Grid (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])
undefined item
Item
text
INDICATE_REASON (NDRSN1)
Item
Treatment required is too close to the edge of the foveal avascular zone
boolean
C0522473 (UMLS CUI [1,1])
C1275950 (UMLS CUI [1,2])
INDICATE_REASON (NDRSN2)
Item
Subject had extensive, adequate prior laser and all leaking microaneurysms associated with edema seen on FA have been laser treated
boolean
C0522473 (UMLS CUI [1,1])
C0333101 (UMLS CUI [1,2])
INDICATE_REASON (NDRSN3)
Item
Component of traction on OCT
boolean
C0154828 (UMLS CUI [1])
INDICATE_REASON (NDRSN4)
Item
Significant non-perfusion on FA
boolean
C0522473 (UMLS CUI [1,1])
C4049512 (UMLS CUI [1,2])
INDICATE_REASON (NDRSN5)
Item
Subject refused laser treatment
boolean
C0522473 (UMLS CUI [1,1])
C0749657 (UMLS CUI [1,2])
INDICATE_REASON (NDRSN6)
Item
Other (specify):
boolean
C0522473 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
OTHER_SPECIFY [OTHSP]
Item
Other (specify):
text
C0522473 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
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