ID

22740

Description

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

Keywords

Versions (1)
  1. 6/11/17 6/11/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 11, 2017

DOI

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License

Creative Commons BY-NC 3.0
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CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

English

CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

1 forms  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Data type

text

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

VDT

Data type

date

Alias
UMLS CUI [1,1]
C1302584
CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12)
Description

CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12)

Were any medications taken?
Description

If Yes, record all medication beginning 7 days prior to Day 0. If indication for medication is an adverse event, complete appropriate Adverse Event CRF.

Data type

boolean

Alias
UMLS CUI [1]
C0013216
Medication
Description

Medication

Line Number
Description

LINE_NUMBER [LN]

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0087111
Medication
Description

MED_RAW_TERM [MDRAW]

Data type

text

Alias
UMLS CUI [1]
C0013216
Indication(s)
Description

MED_INDICATION [MDIND]

Data type

text

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0392360
Date Started
Description

START_DT [STRDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C0808070
DD/MMM/YY
Date Stopped
Description

STOP_DT [STPDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C0806020
DD/MMM/YY
Eye
Description

EYE [EYE]

Data type

integer

Alias
UMLS CUI [1]
C0015392
Eye Code
Description

EYE_CODE [EYECD]

Data type

integer

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0805701
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Similar models

CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12)
MED_RECORDS [MDREC]
Item
Were any medications taken?
boolean
C0013216 (UMLS CUI [1])
Item Group
Medication
LINE_NUMBER [LN]
Item
Line Number
integer
C0449788 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
MED_RAW_TERM [MDRAW]
Item
Medication
text
C0013216 (UMLS CUI [1])
MED_INDICATION [MDIND]
Item
Indication(s)
text
C0013216 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
START_DT [STRDT]
Item
Date Started
date
C0808070 (UMLS CUI [1])
STOP_DT [STPDT]
Item
Date Stopped
date
C0806020 (UMLS CUI [1])
Item
Eye
integer
C0015392 (UMLS CUI [1])
LIGHT_PERCEPTION [LIPEC]
Code List
Eye
CL Item
NA (1)
CL Item
OD (2)
CL Item
OS (3)
Item
Eye Code
integer
C0015392 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
EYE_CODE [EYECD]
Code List
Eye Code
CL Item
Topical (1 )
CL Item
Subconjunctival (2 )
CL Item
Intracranial (anterior chamber) (3 )
CL Item
Intravitreal (4 )
CL Item
Posterior Subtenon’s (5 )
CL Item
Other (99 )
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