ID

22692

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 #: 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

Keywords

Versions (1)
  1. 6/9/17 6/9/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 9, 2017

DOI

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License

Creative Commons BY-NC 3.0
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FOLLOW-UP CONTACT DAY 0 CRFs Roche FVF4170G Macular Edema NCT00473382

English

FOLLOW-UP CONTACT DAY 0 CRFs Roche FVF4170G Macular Edema NCT00473382

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
FOLLOW-UP CONTACT (DAY 0)
Description

FOLLOW-UP CONTACT (DAY 0)

Was the subject contacted 2-4 days after study treatment?
Description

CONTACT [CONTAC]

Data type

boolean

Alias
UMLS CUI [1,1]
C1705415
UMLS CUI [1,2]
C2709088
Date of Contact:
Description

CONTACT_DT [CONDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1705415
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Has the subject been taking the prescribed self-administered post-injection antimicrobials?
Description

Note: If Yes was answered to any of the questions below, the subject should return as soon as possible to the clinic for a safety assessment. Record on AE or SAE CRF if appropriate.

Data type

boolean

Alias
UMLS CUI [1]
C0338237
Decrease in Vision: Has the subject experienced a decrease in vision in the study eye since treatment?
Description

VISION_DECREASED [VSNDEC]

Data type

boolean

Alias
UMLS CUI [1]
C4280600
Eye Pain: Has the subject had any eye pain in the study eye since treatment?
Description

EYE_PAIN [EYEPN]

Data type

boolean

Alias
UMLS CUI [1]
C0151827
Unusual Redness: Has the subject had any new or unusual redness in the study eye (other than localized redness at the injection site) since treatment?
Description

EYE_REDNESS [EYERED]

Data type

boolean

Alias
UMLS CUI [1]
C0235267
New Ocular Symptoms: Has the subject experienced any other new ocular symptoms in the study eye since treatment?
Description

NEW_SYMPTOM [NEWSX]

Data type

boolean

Alias
UMLS CUI [1]
C0586406
Safety Assessment Visit: Was the subject asked to return to the clinic for a safety assessment visit?
Description

ASSESSMENT_DONE [ASMTDN]

Data type

boolean

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C0549076
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Similar models

FOLLOW-UP CONTACT DAY 0 CRFs Roche FVF4170G Macular Edema NCT00473382

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
FOLLOW-UP CONTACT (DAY 0)
CONTACT [CONTAC]
Item
Was the subject contacted 2-4 days after study treatment?
boolean
C1705415 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
CONTACT_DT [CONDT]
Item
Date of Contact:
date
C1705415 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ANTIBIOTICS_CURRENT [ABXCR]
Item
Has the subject been taking the prescribed self-administered post-injection antimicrobials?
boolean
C0338237 (UMLS CUI [1])
VISION_DECREASED [VSNDEC]
Item
Decrease in Vision: Has the subject experienced a decrease in vision in the study eye since treatment?
boolean
C4280600 (UMLS CUI [1])
EYE_PAIN [EYEPN]
Item
Eye Pain: Has the subject had any eye pain in the study eye since treatment?
boolean
C0151827 (UMLS CUI [1])
EYE_REDNESS [EYERED]
Item
Unusual Redness: Has the subject had any new or unusual redness in the study eye (other than localized redness at the injection site) since treatment?
boolean
C0235267 (UMLS CUI [1])
NEW_SYMPTOM [NEWSX]
Item
New Ocular Symptoms: Has the subject experienced any other new ocular symptoms in the study eye since treatment?
boolean
C0586406 (UMLS CUI [1])
ASSESSMENT_DONE [ASMTDN]
Item
Safety Assessment Visit: Was the subject asked to return to the clinic for a safety assessment visit?
boolean
C0589121 (UMLS CUI [1,1])
C0549076 (UMLS CUI [1,2])
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