ID

23312

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 #: FVF4170g 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

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Versiones (1)
  1. 2/7/17 2/7/17 -
Titular de derechos de autor

Genentech, Inc.

Subido en

2 de julio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34) CRFs Roche FVF4170G Macular Edema NCT00473382

Inglés

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34) CRFs Roche FVF4170G Macular Edema NCT00473382

1 formularios  
Patient administration
Descripción

Patient administration

Subject Number
Descripción

PT

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Descripción

PTINIT

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Report Date:
Descripción

VDT

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1302584
RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34)
Descripción

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34)

Eye Treated:
Descripción

EYE (EYE)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015392
Was treatment (Ranibizumab) administered?
Descripción

TX_RECEIVED (TXREC)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1566537
Record Lot # Administered:
Descripción

If Yes,

Tipo de datos

text

Alias
UMLS CUI [1]
C1115660
Date Administered:
Descripción

TREATMENT_DATE (TXDT, TXDTF)

Tipo de datos

date

Unidades de medida
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1566537
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Time Administered:
Descripción

TIME_ADMINISTERED (TXTM)

Tipo de datos

time

Unidades de medida
  • 24 hr clock
Alias
UMLS CUI [1,1]
C1566537
UMLS CUI [1,2]
C0011008
24 hr clock
Was lidocaine injection administered?
Descripción

LIDOCAINE (LDCON)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023660
Were preoperative antimicrobials given?
Descripción

ANTIBIOTICS_CURRENT (ABXCR)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003232
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Similar models

RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34) CRFs Roche FVF4170G Macular Edema NCT00473382

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Patient administration
PT
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
PTINIT
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
VDT
Item
Report Date:
date
C1302584 (UMLS CUI [1,1])
Item Group
RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34)
Item
Eye Treated:
integer
C0015392 (UMLS CUI [1])
EYE (EYE)
Code List
Eye Treated:
CL Item
Right Eye  (1)
CL Item
Left Eye  (2)
CL Item
Not Done (3)
TX_RECEIVED (TXREC)
Item
Was treatment (Ranibizumab) administered?
boolean
C0013216 (UMLS CUI [1,1])
C1566537 (UMLS CUI [1,2])
LOT (LOT)
Item
Record Lot # Administered:
text
C1115660 (UMLS CUI [1])
TREATMENT_DATE (TXDT, TXDTF)
Item
Date Administered:
date
C1566537 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TIME_ADMINISTERED (TXTM)
Item
Time Administered:
time
C1566537 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
LIDOCAINE (LDCON)
Item
Was lidocaine injection administered?
boolean
C0023660 (UMLS CUI [1])
ANTIBIOTICS_CURRENT (ABXCR)
Item
Were preoperative antimicrobials given?
boolean
C0003232 (UMLS CUI [1])
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