ID

23134

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

Mots-clés

Versions (1)
  1. 25/06/2017 25/06/2017 -
Détendeur de droits

Genentech, Inc.

Téléchargé le

25 juin 2017

DOI

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Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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CONCOMITANT MEDICATIONS (MONTH 13 - MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330

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CONCOMITANT MEDICATIONS (MONTH 13 - MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulaires  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Type de données

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Subject Initials:
Description

PTINIT

Type de données

text

Alias
UMLS CUI [1,1]
C1997894 (Clinical trial participant (person))
SNOMED
428024001
UMLS CUI [1,2]
C2986440 (Person Initials)
Report Date:
Description

VDT

Type de données

date

Alias
UMLS CUI [1,1]
C1302584 (Date of report)
SNOMED
399651003
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.

Type de données

boolean

Alias
UMLS CUI [1]
C0013216 (Pharmacotherapy)
SNOMED
416608005
Medication
Description

Medication

Line Number
Description

LINE_NUMBER [LN]

Type de données

integer

Alias
UMLS CUI [1,1]
C0449788 (Count of entities)
SNOMED
410681005
UMLS CUI [1,2]
C0087111 (Therapeutic procedure)
SNOMED
277132007
LOINC
LP21090-3
Medication
Description

MED_RAW_TERM [MDRAW]

Type de données

text

Alias
UMLS CUI [1]
C0013216 (Pharmacotherapy)
SNOMED
416608005
Indication(s)
Description

MED_INDICATION [MDIND]

Type de données

text

Alias
UMLS CUI [1,1]
C0013216 (Pharmacotherapy)
SNOMED
416608005
UMLS CUI [1,2]
C0392360 (Indication of (contextual qualifier))
SNOMED
230165009
LOINC
MTHU008319
Date Started
Description

START_DT [STRDT]

Type de données

date

Unités de mesure
  • DD/MMM/YY
Alias
UMLS CUI [1]
C0808070 (Start Date)
DD/MMM/YY
Date Stopped
Description

STOP_DT [STPDT]

Type de données

date

Unités de mesure
  • DD/MMM/YY
Alias
UMLS CUI [1]
C0806020 (End date)
SNOMED
454551000124105
LOINC
MTHU008302
DD/MMM/YY
Eye
Description

EYE [EYE]

Type de données

integer

Alias
UMLS CUI [1]
C0015392 (Eye)
SNOMED
81745001
LOINC
LP7218-3
Eye Code
Description

EYE_CODE [EYECD]

Type de données

integer

Alias
UMLS CUI [1,1]
C0015392 (Eye)
SNOMED
81745001
LOINC
LP7218-3
UMLS CUI [1,2]
C0805701 (Code)
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Similar models

CONCOMITANT MEDICATIONS (MONTH 13 - MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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