ID
24104
Beschrijving
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
Trefwoorden
Versies (1)
- 25-07-17 25-07-17 -
Houder van rechten
Genentech, Inc.
Geüploaded op
25 juli 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 11) CRFs Roche FVF4168G Macular Edema NCT00473330
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 11) CRFs Roche FVF4168G Macular Edema NCT00473330
Beschrijving
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 11)
Beschrijving
[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.]
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C1512693
Beschrijving
TX_RECEIVED (TXREC)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0743733
Beschrijving
If Yes (Administered):
Datatype
date
Maateenheden
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Beschrijving
TREATMENT_TIME (TXTM)
Datatype
time
Maateenheden
- 24 hr clock
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Beschrijving
TREATMENT_TYPE (TXTYP)
Datatype
integer
Alias
- UMLS CUI [1]
- C1275681
- UMLS CUI [2]
- C1275682
Beschrijving
LASER_BURNS (LSRBRN)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0332708
- UMLS CUI [1,2]
- C0449788
Beschrijving
LASER_POWER (LSRPWR)
Datatype
integer
Maateenheden
- mW
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C3854080
Beschrijving
LASER_DURATION (LSRDUR)
Datatype
integer
Maateenheden
- seconds
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C0449238
Beschrijving
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:
Datatype
text
Beschrijving
INDICATE_REASON (NDRSN1)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C1275950
Beschrijving
INDICATE_REASON (NDRSN2)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0333101
Beschrijving
INDICATE_REASON (NDRSN3)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0154828
Beschrijving
INDICATE_REASON (NDRSN4)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C4049512
Beschrijving
INDICATE_REASON (NDRSN5)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0749657
Beschrijving
INDICATE_REASON (NDRSN6)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Beschrijving
OTHER_SPECIFY [OTHSP]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Similar models
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 11) 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])