ID

24110

Descripción

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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Versiones (1)
  1. 25/7/17 25/7/17 -
Titular de derechos de autor

Genentech, Inc.

Subido en

25 de julio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 17) CRFs Roche FVF4168G Macular Edema NCT00473330

Inglés

RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 17) CRFs Roche FVF4168G Macular Edema NCT00473330

1 formularios  
Patient administration
Descripción

Patient administration

Subject Number
Descripción

PT

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Descripción

PTINIT

Tipo de datos

text

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

VDT

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1302584
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 17)
Descripción

RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 17)

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

[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.]

Tipo de datos

boolean

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

TX_RECEIVED (TXREC)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0743733
Date Administered:
Descripción

If Yes (Administered):

Tipo de datos

date

Unidades de medida
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0743733
UMLS CUI [1,2]
C4255413
DD/MMM/YY
Time Administered:
Descripción

TREATMENT_TIME (TXTM)

Tipo de datos

time

Unidades de medida
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0743733
UMLS CUI [1,2]
C4255413
24 hr clock
Type of Laser:
Descripción

TREATMENT_TYPE (TXTYP)

Tipo de datos

integer

Alias
UMLS CUI [1]
C1275681
UMLS CUI [2]
C1275682
# of Laser Burns:
Descripción

LASER_BURNS (LSRBRN)

Tipo de datos

integer

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

LASER_POWER (LSRPWR)

Tipo de datos

integer

Unidades de medida
  • mW
Alias
UMLS CUI [1,1]
C0023089
UMLS CUI [1,2]
C3854080
mW
Duration of Laser:
Descripción

LASER_DURATION (LSRDUR)

Tipo de datos

integer

Unidades de medida
  • seconds
Alias
UMLS CUI [1,1]
C0023089
UMLS CUI [1,2]
C0449238
seconds
undefined item
Descripción

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:

Tipo de datos

text

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

INDICATE_REASON (NDRSN1)

Tipo de datos

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
Descripción

INDICATE_REASON (NDRSN2)

Tipo de datos

boolean

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

INDICATE_REASON (NDRSN3)

Tipo de datos

boolean

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

INDICATE_REASON (NDRSN4)

Tipo de datos

boolean

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

INDICATE_REASON (NDRSN5)

Tipo de datos

boolean

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

INDICATE_REASON (NDRSN6)

Tipo de datos

boolean

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

OTHER_SPECIFY [OTHSP]

Tipo de datos

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 17) CRFs Roche FVF4168G Macular Edema NCT00473330

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 17)
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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