ID

22685

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 (2)
  1. 07/06/2017 07/06/2017 -
  2. 09/06/2017 09/06/2017 -
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 :

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

STUDY DRUG ADMINISTRATION DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

Anglais

STUDY DRUG ADMINISTRATION DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulaires  
STUDY DRUG ADMINISTRATION (DAY 0)
Description

STUDY DRUG ADMINISTRATION (DAY 0)

Eye Treated:
Description

EYE [EYE]

Type de données

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0229089
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0229090
Was treatment (Ranibizumab or sham procedure) administered?
Description

TREATMENT_RECEIVED [TXREC]

Type de données

boolean

Alias
UMLS CUI [1]
C1725180
UMLS CUI [2]
C0032042
If Yes, Record kit # administered:
Description

KIT [KIT]

Type de données

integer

Alias
UMLS CUI [1]
C2981406
Date Administered:
Description

TREATMENT_DT [TXDT]

Type de données

date

Unités de mesure
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Time Administered:
Description

TREATMENT_TIME [TXTM]

Type de données

time

Unités de mesure
  • 24 hr clock
Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0040223
24 hr clock
Was lidocaine injection administered?
Description

LIDOCAINE [LDOCN]

Type de données

boolean

Alias
UMLS CUI [1]
C0360095
Were preoperative antimicrobials given?
Description

ANTIBIOTICS_CURRENT [ABXCR]

Type de données

boolean

Alias
UMLS CUI [1]
C0338237
If No, Was treatment held due to any of the Study Drug Dose-Holding Criteria?
Description

TX_HELD [TXHELD]

Type de données

boolean

Alias
UMLS CUI [1]
C0557960
If Yes, check the corresponding event(s) for holding treatment: Intraocular inflammation
Description

TREATMENT_HELD_CRITERIA [TXHLDC1]

Type de données

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0042164
Visual acuity loss
Description

TREATMENT_HELD_CRITERIA [TXHLDC2]

Type de données

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0234632
Intraocular pressure (IOP)
Description

TREATMENT_HELD_CRITERIA [TXHLDC3]

Type de données

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0578862
Sensory rhegmatogenous retinal break or detachment
Description

TREATMENT_HELD_CRITERIA [TXHLDC4]

Type de données

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C2880797
Local or systemic infection
Description

TREATMENT_HELD_CRITERIA [TXHLDC5]

Type de données

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C3714514
Intraocular surgery
Description

TREATMENT_HELD_CRITERIA [TXHLDC6]

Type de données

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0038901
Other:
Description

TREATMENT_HELD_CRITERIA [TXHLDC7]

Type de données

boolean

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
Other:
Description

OTHER_SPECIFY (OTHSP)

Type de données

text

Alias
UMLS CUI [1,1]
C0557960
UMLS CUI [1,2]
C0566251
Retour au début de la page

Similar models

STUDY DRUG ADMINISTRATION DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
STUDY DRUG ADMINISTRATION (DAY 0)
Item
Eye Treated:
integer
C0087111 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0229090 (UMLS CUI [2,2])
EYE [EYE]
Code List
Eye Treated:
CL Item
Right Eye  (1)
CL Item
Left Eye (2)
TREATMENT_RECEIVED [TXREC]
Item
Was treatment (Ranibizumab or sham procedure) administered?
boolean
C1725180 (UMLS CUI [1])
C0032042 (UMLS CUI [2])
KIT [KIT]
Item
If Yes, Record kit # administered:
integer
C2981406 (UMLS CUI [1])
TREATMENT_DT [TXDT]
Item
Date Administered:
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TREATMENT_TIME [TXTM]
Item
Time Administered:
time
C1533734 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
LIDOCAINE [LDOCN]
Item
Was lidocaine injection administered?
boolean
C0360095 (UMLS CUI [1])
ANTIBIOTICS_CURRENT [ABXCR]
Item
Were preoperative antimicrobials given?
boolean
C0338237 (UMLS CUI [1])
TX_HELD [TXHELD]
Item
If No, Was treatment held due to any of the Study Drug Dose-Holding Criteria?
boolean
C0557960 (UMLS CUI [1])
TREATMENT_HELD_CRITERIA [TXHLDC1]
Item
If Yes, check the corresponding event(s) for holding treatment: Intraocular inflammation
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0042164 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC2]
Item
Visual acuity loss
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0234632 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC3]
Item
Intraocular pressure (IOP)
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0578862 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC4]
Item
Sensory rhegmatogenous retinal break or detachment
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C2880797 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC5]
Item
Local or systemic infection
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC6]
Item
Intraocular surgery
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0038901 (UMLS CUI [1,3])
TREATMENT_HELD_CRITERIA [TXHLDC7]
Item
Other:
boolean
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
OTHER_SPECIFY (OTHSP)
Item
Other:
text
C0557960 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
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