ID

22687

Beschrijving

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

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Versies (1)
  1. 09-06-17 09-06-17 -
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9 juni 2017

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Creative Commons BY-NC 3.0 Legacy
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STUDY DRUG ADMINISTRATION DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

Engels

STUDY DRUG ADMINISTRATION DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulieren  
Patient administration
Beschrijving

Patient administration

Subject Number
Beschrijving

PT

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschrijving

PTINIT

Datatype

text

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

VDT

Datatype

date

Alias
UMLS CUI [1,1]
C1302584
STUDY DRUG ADMINISTRATION (DAY 0)
Beschrijving

STUDY DRUG ADMINISTRATION (DAY 0)

Eye Treated:
Beschrijving

EYE [EYE]

Datatype

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0229089
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0229090
Was treatment (Ranibizumab or sham procedure) administered?
Beschrijving

TREATMENT_RECEIVED [TXREC]

Datatype

boolean

Alias
UMLS CUI [1]
C1725180
UMLS CUI [2]
C0032042
If Yes, Record kit # administered:
Beschrijving

KIT [KIT]

Datatype

integer

Alias
UMLS CUI [1]
C2981406
Date Administered:
Beschrijving

TREATMENT_DT [TXDT]

Datatype

date

Maateenheden
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Time Administered:
Beschrijving

TREATMENT_TIME [TXTM]

Datatype

time

Maateenheden
  • 24 hr clock
Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0040223
24 hr clock
Was lidocaine injection administered?
Beschrijving

LIDOCAINE [LDOCN]

Datatype

boolean

Alias
UMLS CUI [1]
C0360095
Were preoperative antimicrobials given?
Beschrijving

ANTIBIOTICS_CURRENT [ABXCR]

Datatype

boolean

Alias
UMLS CUI [1]
C0338237
If No, Was treatment held due to any of the Study Drug Dose-Holding Criteria?
Beschrijving

TX_HELD [TXHELD]

Datatype

boolean

Alias
UMLS CUI [1]
C0557960
If Yes, check the corresponding event(s) for holding treatment: Intraocular inflammation
Beschrijving

TREATMENT_HELD_CRITERIA [TXHLDC1]

Datatype

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0042164
Visual acuity loss
Beschrijving

TREATMENT_HELD_CRITERIA [TXHLDC2]

Datatype

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0234632
Intraocular pressure (IOP)
Beschrijving

TREATMENT_HELD_CRITERIA [TXHLDC3]

Datatype

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0578862
Sensory rhegmatogenous retinal break or detachment
Beschrijving

TREATMENT_HELD_CRITERIA [TXHLDC4]

Datatype

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C2880797
Local or systemic infection
Beschrijving

TREATMENT_HELD_CRITERIA [TXHLDC5]

Datatype

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C3714514
Intraocular surgery
Beschrijving

TREATMENT_HELD_CRITERIA [TXHLDC6]

Datatype

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0038901
Other:
Beschrijving

TREATMENT_HELD_CRITERIA [TXHLDC7]

Datatype

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
Other:
Beschrijving

OTHER_SPECIFY (OTHSP)

Datatype

text

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
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Similar models

STUDY DRUG ADMINISTRATION DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
STUDY DRUG ADMINISTRATION (DAY 0)
Item
Eye Treated:
integer
C0087111 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0229090 (UMLS CUI [2,2])
EYE [EYE]
Code List
Eye Treated:
CL Item
Right Eye  (1)
CL Item
Left Eye (2)
TREATMENT_RECEIVED [TXREC]
Item
Was treatment (Ranibizumab or sham procedure) administered?
boolean
C1725180 (UMLS CUI [1])
C0032042 (UMLS CUI [2])
KIT [KIT]
Item
If Yes, Record kit # administered:
integer
C2981406 (UMLS CUI [1])
TREATMENT_DT [TXDT]
Item
Date Administered:
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TREATMENT_TIME [TXTM]
Item
Time Administered:
time
C1533734 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
LIDOCAINE [LDOCN]
Item
Was lidocaine injection administered?
boolean
C0360095 (UMLS CUI [1])
ANTIBIOTICS_CURRENT [ABXCR]
Item
Were preoperative antimicrobials given?
boolean
C0338237 (UMLS CUI [1])
TX_HELD [TXHELD]
Item
If No, Was treatment held due to any of the Study Drug Dose-Holding Criteria?
boolean
C0557960 (UMLS CUI [1])
TREATMENT_HELD_CRITERIA [TXHLDC1]
Item
If Yes, check the corresponding event(s) for holding treatment: Intraocular inflammation
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0042164 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC2]
Item
Visual acuity loss
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0234632 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC3]
Item
Intraocular pressure (IOP)
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0578862 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC4]
Item
Sensory rhegmatogenous retinal break or detachment
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C2880797 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC5]
Item
Local or systemic infection
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC6]
Item
Intraocular surgery
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0038901 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC7]
Item
Other:
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
OTHER_SPECIFY (OTHSP)
Item
Other:
text
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
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