ID

22602

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-06-08 2017-06-08 -
Rättsinnehavare

Genentech, Inc.

Uppladdad den

8 juni 2017

DOI

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Creative Commons BY-NC 3.0
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GENERAL MEDICAL HISTORY AND BASELINE CONDITIONS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

Engelsk

GENERAL MEDICAL HISTORY AND BASELINE CONDITIONS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulär  
Patient administration
Beskrivning

Patient administration

Subject Number
Beskrivning

PT

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beskrivning

PTINIT

Datatyp

text

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

VDT

Datatyp

date

Alias
UMLS CUI [1,1]
C1302584
GENERAL MEDICAL HISTORY AND BASELINE CONDITIONS (SCREENING)
Beskrivning

GENERAL MEDICAL HISTORY AND BASELINE CONDITIONS (SCREENING)

Does the subject have any other medical history or baseline conditions, not specified on a Targeted Medical History CRF?
Beskrivning

If Yes, record each diagnosis and its status below. Do not record diagnoses / physical findings already captured on the Targeted Medical History CRF. The following Systems / Categories should be reviewed by the investigator: Neurologic / Psychiatric • Gastrointestinal • Endocrine • Ophthalmologic • Genitourinary / Reproductive • Hematologic • Ears, Nose, Throat • Musculoskeletal • Allergies / Drug Sensitivities • Cardiovascular • Dermatologic • Malignancy • Respiratory

Datatyp

boolean

Alias
UMLS CUI [1]
C0262926
Other Medical History
Beskrivning

Other Medical History

Line Number
Beskrivning

LINE_NUMBER [LN]

Datatyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0087111
Diagnosis
Beskrivning

MED_HX_DESCRIPTION [HXDES]

Datatyp

text

Alias
UMLS CUI [1]
C0011900
Condition Currently Active?
Beskrivning

MED_HX_ACTIVE [HXACT]

Datatyp

boolean

Alias
UMLS CUI [1]
C2707252
Onset Date
Beskrivning

MED_HX_DT [HXDT]

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0439673
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Similar models

GENERAL MEDICAL HISTORY AND BASELINE CONDITIONS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
GENERAL MEDICAL HISTORY AND BASELINE CONDITIONS (SCREENING)
MED_HX_RECORDS
Item
Does the subject have any other medical history or baseline conditions, not specified on a Targeted Medical History CRF?
boolean
C0262926 (UMLS CUI [1])
Item Group
Other Medical History
LINE_NUMBER [LN]
Item
Line Number
integer
C0449788 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
MED_HX_DESCRIPTION [HXDES]
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
MED_HX_ACTIVE [HXACT]
Item
Condition Currently Active?
boolean
C2707252 (UMLS CUI [1])
MED_HX_DT [HXDT]
Item
Onset Date
boolean
C0574845 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
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