ID

28971

Description

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.

Keywords

Versions (1)
  1. 2/18/18 2/18/18 -
Copyright Holder

Roche

Uploaded on

February 18, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Study Drug Administration Month 3 rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g

English

Study Drug Administration Month 3

1 forms  
STUDY DRUG ADMINISTRATION (MONTH 3)
Description

STUDY DRUG ADMINISTRATION (MONTH 3)

Alias
UMLS CUI-1
C3469597
Subject Number:
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

Subject Initials

Data type

text

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

Visit Date

Data type

date

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

Therapy

Data type

boolean

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

identification number

Data type

text

Alias
UMLS CUI [1]
C1300638
Date Administered:
Description

Date Administered

Data type

date

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

Time Administered

Data type

time

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

Drug Administration lidocaine

Data type

boolean

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

preoperative antimicrobials

Data type

boolean

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

drug dosage

Data type

boolean

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

Therapy

Data type

text

Alias
UMLS CUI [1]
C0087111
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Similar models

Study Drug Administration Month 3

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Therapy
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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