ID

22681

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

Mots-clés

Versions (1)
  1. 09/06/2017 09/06/2017 -
Détendeur de droits

Genentech, Inc.

Téléchargé le

9 juin 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

Aucun commentaire

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

INTRAOCULAR PRESSURE (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

Anglais

INTRAOCULAR PRESSURE (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

1 Formulaires  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Type de données

text

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

VDT

Type de données

date

Alias
UMLS CUI [1,1]
C1302584
INTRAOCULAR PRESSURE (DAY 0)
Description

INTRAOCULAR PRESSURE (DAY 0)

Pre-dose Right Eye
Description

INTRAOCULAR_PRESSURE [ IOP]

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229089
mmHg
Pre-dose Right Eye Not Done
Description

INTRAOCULAR_PRESSURE [ IOP]

Type de données

boolean

Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229089
Pre-dose Left Eye
Description

INTRAOCULAR_PRESSURE [ IOP]

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229090
mmHg
Pre-dose Left Eye Not Done
Description

INTRAOCULAR_PRESSURE [ IOP]

Type de données

boolean

Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0229090
Predose Date
Description

EXAM_DT [EXMDT]

Type de données

date

Unités de mesure
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0011008
DD/MMM/YY
Predose Actual Time
Description

EXAM_TIME [EXMTM]

Type de données

time

Unités de mesure
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0040223
24 hr clock
Predose Method
Description

Method must be consistent for a subject throughout the study.

Type de données

integer

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0871511
60 min post-dose Study Eye
Description

QV: STUDY EYE

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0681850
mmHg
60 min post-dose Study Eye Not Done
Description

QV: STUDY EYE

Type de données

boolean

Alias
UMLS CUI [1,1]
C0578862
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0681850
60 min post-dose Date
Description

EXAM_DT [EXMDT]

Type de données

date

Unités de mesure
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439571
UMLS CUI [1,3]
C0011008
DD/MMM/YY
60 min post-dose Actual Time
Description

EXAM_TIME [EXMTM]

Type de données

time

Unités de mesure
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439571
UMLS CUI [1,3]
C0040223
24 hr clock
60 min post-dose Method
Description

Method must be consistent for a subject throughout the study.

Type de données

integer

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0439571
UMLS CUI [1,3]
C0871511
Retour au début de la page

Similar models

INTRAOCULAR PRESSURE (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

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
INTRAOCULAR PRESSURE (DAY 0)
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Right Eye
integer
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Right Eye Not Done
boolean
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Left Eye
integer
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
INTRAOCULAR_PRESSURE [ IOP]
Item
Pre-dose Left Eye Not Done
boolean
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
EXAM_DT [EXMDT]
Item
Predose Date
date
C0430888 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
EXAM_TIME [EXMTM]
Item
Predose Actual Time
time
C0430888 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Predose Method
integer
C0430888 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0871511 (UMLS CUI [1,3])
PROCEDURE_TYPE [PRCTYP]
Code List
Predose Method
CL Item
Applanation tonometry (1)
CL Item
Non-contact tonometry (2)
CL Item
Tonopen (3)
CL Item
Pneumotonometry (4)
QV: STUDY EYE
Item
60 min post-dose Study Eye
integer
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
QV: STUDY EYE
Item
60 min post-dose Study Eye Not Done
boolean
C0578862 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
EXAM_DT [EXMDT]
Item
60 min post-dose Date
date
C0430888 (UMLS CUI [1,1])
C0439571 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
EXAM_TIME [EXMTM]
Item
60 min post-dose Actual Time
time
C0430888 (UMLS CUI [1,1])
C0439571 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
60 min post-dose Method
integer
C0430888 (UMLS CUI [1,1])
C0439571 (UMLS CUI [1,2])
C0871511 (UMLS CUI [1,3])
PROCEDURE_TYPE [PRCTYP]
Code List
60 min post-dose Method
CL Item
Applanation tonometry (1)
CL Item
Non-contact tonometry (2)
CL Item
Tonopen (3)
CL Item
Pneumotonometry (4)
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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