ID

22692

Descrizione

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

versioni (1)
  1. 09/06/17 09/06/17 -
Titolare del copyright

Genentech, Inc.

Caricato su

9 giugno 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

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

Inglese

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

1 moduli  
Patient administration
Descrizione

Patient administration

Subject Number
Descrizione

PT

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Descrizione

PTINIT

Tipo di dati

text

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

VDT

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1302584
FOLLOW-UP CONTACT (DAY 0)
Descrizione

FOLLOW-UP CONTACT (DAY 0)

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

CONTACT [CONTAC]

Tipo di dati

boolean

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

CONTACT_DT [CONDT]

Tipo di dati

date

Unità di misura
  • 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?
Descrizione

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.

Tipo di dati

boolean

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

VISION_DECREASED [VSNDEC]

Tipo di dati

boolean

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

EYE_PAIN [EYEPN]

Tipo di dati

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?
Descrizione

EYE_REDNESS [EYERED]

Tipo di dati

boolean

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

NEW_SYMPTOM [NEWSX]

Tipo di dati

boolean

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

ASSESSMENT_DONE [ASMTDN]

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C0549076
Ritorna all'inizio della pagina

Similar models

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

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial