ID

24110

Beschreibung

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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  1. 25.07.17 25.07.17 -
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Genentech, Inc.

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25. Juli 2017

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

Englisch

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

1 Formulare  
Patient administration
Beschreibung

Patient administration

Subject Number
Beschreibung

PT

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschreibung

PTINIT

Datentyp

text

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

VDT

Datentyp

date

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

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?
Beschreibung

[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.]

Datentyp

boolean

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

TX_RECEIVED (TXREC)

Datentyp

boolean

Alias
UMLS CUI [1]
C0743733
Date Administered:
Beschreibung

If Yes (Administered):

Datentyp

date

Maßeinheiten
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0743733
UMLS CUI [1,2]
C4255413
DD/MMM/YY
Time Administered:
Beschreibung

TREATMENT_TIME (TXTM)

Datentyp

time

Maßeinheiten
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0743733
UMLS CUI [1,2]
C4255413
24 hr clock
Type of Laser:
Beschreibung

TREATMENT_TYPE (TXTYP)

Datentyp

integer

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

LASER_BURNS (LSRBRN)

Datentyp

integer

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

LASER_POWER (LSRPWR)

Datentyp

integer

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

LASER_DURATION (LSRDUR)

Datentyp

integer

Maßeinheiten
  • seconds
Alias
UMLS CUI [1,1]
C0023089
UMLS CUI [1,2]
C0449238
seconds
undefined item
Beschreibung

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:

Datentyp

text

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

INDICATE_REASON (NDRSN1)

Datentyp

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
Beschreibung

INDICATE_REASON (NDRSN2)

Datentyp

boolean

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

INDICATE_REASON (NDRSN3)

Datentyp

boolean

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

INDICATE_REASON (NDRSN4)

Datentyp

boolean

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

INDICATE_REASON (NDRSN5)

Datentyp

boolean

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

INDICATE_REASON (NDRSN6)

Datentyp

boolean

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

OTHER_SPECIFY [OTHSP]

Datentyp

text

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C3840932
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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