ID
23265
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 (3)
- 7/1/17 7/1/17 -
- 7/1/17 7/1/17 -
- 7/25/17 7/25/17 -
Copyright Holder
Genentech, Inc.
Uploaded on
July 1, 2017
DOI
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License
Creative Commons BY-NC 3.0
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STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330
STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330
Description
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 3)
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
Description
TX_RECEIVED (TXREC)
Data type
boolean
Alias
- UMLS CUI [1]
- C0743733
Description
If Yes (Administered):
Data type
date
Measurement units
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Description
TREATMENT_TIME (TXTM)
Data type
time
Measurement units
- 24 hr clock
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Description
TREATMENT_TYPE (TXTYP)
Data type
integer
Alias
- UMLS CUI [1]
- C1275681
- UMLS CUI [2]
- C1275682
Description
LASER_BURNS (LSRBRN)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0332708
- UMLS CUI [1,2]
- C0449788
Description
LASER_POWER (LSRPWR)
Data type
integer
Measurement units
- mW
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C3854080
Description
LASER_DURATION (LSRDUR)
Data type
integer
Measurement units
- seconds
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C0449238
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
Description
INDICATE_REASON (NDRSN1)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C1275950
Description
INDICATE_REASON (NDRSN2)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0333101
Description
INDICATE_REASON (NDRSN3)
Data type
boolean
Alias
- UMLS CUI [1]
- C0522473
Description
INDICATE_REASON (NDRSN4)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C4049512
Description
INDICATE_REASON (NDRSN5)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0749657
Description
INDICATE_REASON (NDRSN6)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Description
OTHER_SPECIFY [OTHSP]
Data type
text
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Similar models
STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330
C2986440 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,2])
C4255413 (UMLS CUI [1,2])
C4255413 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C3854080 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C1275950 (UMLS CUI [1,2])
C0333101 (UMLS CUI [1,2])
C4049512 (UMLS CUI [1,2])
C0749657 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])