ID

23206

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

Keywords

  1. 6/28/17 6/28/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 28, 2017

DOI

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License

Creative Commons BY-NC 3.0

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PREGNANCY REPORT (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

PREGNANCY REPORT (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

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
PREGNANCY REPORT (UNSCHEDULED)
Description

PREGNANCY REPORT (UNSCHEDULED)

Pregnancy status on the date this report was completed (check one only):
Description

Complete if the subject became pregnant during the course of the study or 30 days after study drug treatment.

Data type

integer

Alias
UMLS CUI [1]
C0032961

Similar models

PREGNANCY REPORT (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

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
PREGNANCY REPORT (UNSCHEDULED)
Item
Pregnancy status on the date this report was completed (check one only):
integer
C0032961 (UMLS CUI [1])
Code List
Pregnancy status on the date this report was completed (check one only):
CL Item
Subject delivered (1)
CL Item
Pregnancy ongoing (not delivered) (2)
CL Item
Pregnancy not ongoing (3)

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