ID

23263

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

Keywords

Versions (1)
  1. 7/1/17 7/1/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

July 1, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

English

STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

1 forms  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Data type

text

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

VDT

Data type

date

Alias
UMLS CUI [1,1]
C1302584
STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
Description

STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)

Indicate if the subject completed the study or discontinued early (check one only):
Description

DISC_COMPLETED_STUDY [DCCMP]

Data type

integer

Alias
UMLS CUI [1]
C2826674
Date Subject Completed or Discontinued Early from Study:
Description

DISC_COMP_DT [DCCDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2983670
DD/MMM/YY
Check the PRIMARY reason the subject discontinued early from the study (check one only):
Description

DISC_PRIMARY_REASON [DCRS]

Data type

integer

Alias
UMLS CUI [1,1]
C2348571
UMLS CUI [1,2]
C0566251
Please specify intervention:
Description

DISC_PRIMARY_REAS_SP [DCRSP]

Data type

text

Alias
UMLS CUI [1,1]
C2348571
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0184661
Back to the top of the page

Similar models

STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
Item
Indicate if the subject completed the study or discontinued early (check one only):
integer
C2826674 (UMLS CUI [1])
TX_DRUG_DISC [TXDISC]
Code List
Indicate if the subject completed the study or discontinued early (check one only):
CL Item
Subject Completed Study  (1)
CL Item
Subject Discontinued Early (2)
DISC_COMP_DT [DCCDT]
Item
Date Subject Completed or Discontinued Early from Study:
date
C2983670 (UMLS CUI [1])
Item
Check the PRIMARY reason the subject discontinued early from the study (check one only):
integer
C2348571 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
TX_DRUG_DISC_REASON [TXREAS]
Code List
Check the PRIMARY reason the subject discontinued early from the study (check one only):
CL Item
Adverse Event (complete appropriate Adverse Event CRF) (1)
CL Item
Death (complete Study Completion / Early Discontinuation CRF) (2)
CL Item
Lost to follow-up (3)
CL Item
Physician’s decision to discontinue treatment (for reasons other than AE) (4)
CL Item
Subject’s decision to withdraw (for reasons other than AE) (5)
CL Item
Sponsor’s decision to terminate study (6)
CL Item
Pregnancy (complete Pregnancy CRF) (7)
CL Item
Subject non-compliance (8)
CL Item
Subject’s condition mandated other therapeutic intervention (9)
DISC_PRIMARY_REAS_SP [DCRSP]
Item
Please specify intervention:
text
C2348571 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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