ID
24102
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-07-25 2017-07-25 -
Rättsinnehavare
Genentech, Inc.
Uppladdad den
25 juli 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 9) CRFs Roche FVF4168G Macular Edema NCT00473330
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 9) CRFs Roche FVF4168G Macular Edema NCT00473330
Beskrivning
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 9)
Beskrivning
[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.]
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C1512693
Beskrivning
TX_RECEIVED (TXREC)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0743733
Beskrivning
If Yes (Administered):
Datatyp
date
Måttenheter
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Beskrivning
TREATMENT_TIME (TXTM)
Datatyp
time
Måttenheter
- 24 hr clock
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Beskrivning
TREATMENT_TYPE (TXTYP)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1275681
- UMLS CUI [2]
- C1275682
Beskrivning
LASER_BURNS (LSRBRN)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0332708
- UMLS CUI [1,2]
- C0449788
Beskrivning
LASER_POWER (LSRPWR)
Datatyp
integer
Måttenheter
- mW
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C3854080
Beskrivning
LASER_DURATION (LSRDUR)
Datatyp
integer
Måttenheter
- seconds
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C0449238
Beskrivning
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:
Datatyp
text
Beskrivning
INDICATE_REASON (NDRSN1)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C1275950
Beskrivning
INDICATE_REASON (NDRSN2)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0333101
Beskrivning
INDICATE_REASON (NDRSN3)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0154828
Beskrivning
INDICATE_REASON (NDRSN4)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C4049512
Beskrivning
INDICATE_REASON (NDRSN5)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0749657
Beskrivning
INDICATE_REASON (NDRSN6)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Beskrivning
OTHER_SPECIFY [OTHSP]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Similar models
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 9) 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])