ID

28971

Descripción

Study part: Study Drug Administration Month 3. A Phase III, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) In Subjects With Minimally Classic Or Occult Subfoveal Neovascular Age-Related Macular Degeneration.

Palabras clave

  1. 18/2/18 18/2/18 -
Titular de derechos de autor

Roche

Subido en

18 de febrero de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0

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Study Drug Administration Month 3 rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g

Study Drug Administration Month 3

STUDY DRUG ADMINISTRATION (MONTH 3)
Descripción

STUDY DRUG ADMINISTRATION (MONTH 3)

Alias
UMLS CUI-1
C3469597
Subject Number:
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Descripción

Subject Initials

Tipo de datos

text

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

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Was treatment (rhuFab V2 or sham procedure) administered?
Descripción

Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
If Yes, Record kit # administered:
Descripción

identification number

Tipo de datos

text

Alias
UMLS CUI [1]
C1300638
Date Administered:
Descripción

Date Administered

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1533734
Time Administered:
Descripción

Time Administered

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1533734
Was lidocaine injection administered?
Descripción

Drug Administration lidocaine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0023660
Were preoperative antimicrobials given?
Descripción

preoperative antimicrobials

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2114165
If No, Was treatment held due to any of the Study Drug Dose-Holding Criteria?
Descripción

drug dosage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0870450
If Yes, check the corresponding event(s) for holding treatment:
Descripción

Therapy

Tipo de datos

text

Alias
UMLS CUI [1]
C0087111

Similar models

Study Drug Administration Month 3

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
STUDY DRUG ADMINISTRATION (MONTH 3)
C3469597 (UMLS CUI-1)
Subject Number
Item
Subject Number:
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Visit Date
Item
Visit Date:
date
C1320303 (UMLS CUI [1])
Therapy
Item
Was treatment (rhuFab V2 or sham procedure) administered?
boolean
C0087111 (UMLS CUI [1])
identification number
Item
If Yes, Record kit # administered:
text
C1300638 (UMLS CUI [1])
Date Administered
Item
Date Administered:
date
C0011008 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Time Administered
Item
Time Administered:
time
C0040223 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Drug Administration lidocaine
Item
Was lidocaine injection administered?
boolean
C3469597 (UMLS CUI [1,1])
C0023660 (UMLS CUI [1,2])
preoperative antimicrobials
Item
Were preoperative antimicrobials given?
boolean
C2114165 (UMLS CUI [1])
drug dosage
Item
If No, Was treatment held due to any of the Study Drug Dose-Holding Criteria?
boolean
C0870450 (UMLS CUI [1])
Item
If Yes, check the corresponding event(s) for holding treatment:
text
C0087111 (UMLS CUI [1])
Code List
If Yes, check the corresponding event(s) for holding treatment:
CL Item
Intraocular inflammation (Intraocular inflammation)
C0497211 (UMLS CUI-1)
(Comment:en)
CL Item
Visual acuity loss (Visual acuity loss)
C1836949 (UMLS CUI-1)
(Comment:en)
CL Item
Intraocular pressure (IOP) (Intraocular pressure (IOP))
C0578862 (UMLS CUI-1)
(Comment:en)
CL Item
Vitreous hemorrhage (Vitreous hemorrhage)
C0042909 (UMLS CUI-1)
(Comment:en)
CL Item
Sensory rhegmatogenous retinal break or detachment (Sensory rhegmatogenous retinal break or detachment)
C0035305 (UMLS CUI-1)
(Comment:en)
CL Item
Subfoveal hemorrhage (Subfoveal hemorrhage)
C0442185 (UMLS CUI-1)
C0019080 (UMLS CUI-2)
(Comment:en)
CL Item
Local or systemic infection (Local or systemic infection)
C0009450 (UMLS CUI-1)
(Comment:en)
CL Item
Intraocular surgery (Intraocular surgery)
C0038894 (UMLS CUI-1)
C3282905 (UMLS CUI-2)
(Comment:en)

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