ID
23265
Descripción
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
Palabras clave
Versiones (3)
- 1/7/17 1/7/17 -
- 1/7/17 1/7/17 -
- 25/7/17 25/7/17 -
Titular de derechos de autor
Genentech, Inc.
Subido en
1 de julio de 2017
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330
STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330
Descripción
RESCUE LASER ADMINISTRATION AND CRITERIA STUDY EYE (MONTH 3)
Descripción
[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.]
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C1512693
Descripción
TX_RECEIVED (TXREC)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0743733
Descripción
If Yes (Administered):
Tipo de datos
date
Unidades de medida
- DD/MMM/YY
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Descripción
TREATMENT_TIME (TXTM)
Tipo de datos
time
Unidades de medida
- 24 hr clock
Alias
- UMLS CUI [1,1]
- C0743733
- UMLS CUI [1,2]
- C4255413
Descripción
TREATMENT_TYPE (TXTYP)
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1275681
- UMLS CUI [2]
- C1275682
Descripción
LASER_BURNS (LSRBRN)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0332708
- UMLS CUI [1,2]
- C0449788
Descripción
LASER_POWER (LSRPWR)
Tipo de datos
integer
Unidades de medida
- mW
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C3854080
Descripción
LASER_DURATION (LSRDUR)
Tipo de datos
integer
Unidades de medida
- seconds
Alias
- UMLS CUI [1,1]
- C0023089
- UMLS CUI [1,2]
- C0449238
Descripción
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:
Tipo de datos
text
Descripción
INDICATE_REASON (NDRSN1)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C1275950
Descripción
INDICATE_REASON (NDRSN2)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0333101
Descripción
INDICATE_REASON (NDRSN3)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0522473
Descripción
INDICATE_REASON (NDRSN4)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C4049512
Descripción
INDICATE_REASON (NDRSN5)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0749657
Descripción
INDICATE_REASON (NDRSN6)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C3840932
Descripción
OTHER_SPECIFY [OTHSP]
Tipo de datos
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])