ID
23265
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
Stichworte
Versionen (3)
- 01.07.17 01.07.17 -
- 01.07.17 01.07.17 -
- 25.07.17 25.07.17 -
Rechteinhaber
Genentech, Inc.
Hochgeladen am
1. Juli 2017
DOI
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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
Beschreibung
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 3)
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
Beschreibung
TX_RECEIVED (TXREC)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0743733
Beschreibung
If Yes (Administered):
Datentyp
date
Maßeinheiten
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Beschreibung
TREATMENT_TIME (TXTM)
Datentyp
time
Maßeinheiten
- 24 hr clock
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Beschreibung
TREATMENT_TYPE (TXTYP)
Datentyp
integer
Alias
- UMLS CUI [1]
- C1275681
- UMLS CUI [2]
- C1275682
Beschreibung
LASER_BURNS (LSRBRN)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0332708
- UMLS CUI [1,2]
- C0449788
Beschreibung
LASER_POWER (LSRPWR)
Datentyp
integer
Maßeinheiten
- mW
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C3854080
Beschreibung
LASER_DURATION (LSRDUR)
Datentyp
integer
Maßeinheiten
- seconds
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C0449238
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
Beschreibung
INDICATE_REASON (NDRSN1)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C1275950
Beschreibung
INDICATE_REASON (NDRSN2)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0333101
Beschreibung
INDICATE_REASON (NDRSN3)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0522473
Beschreibung
INDICATE_REASON (NDRSN4)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C4049512
Beschreibung
INDICATE_REASON (NDRSN5)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0749657
Beschreibung
INDICATE_REASON (NDRSN6)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Beschreibung
OTHER_SPECIFY [OTHSP]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Ähnliche Modelle
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])