ID

23348

Beschrijving

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

Trefwoorden

Versies (1)
  1. 02-07-17 02-07-17 -
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Genentech, Inc.

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2 juli 2017

DOI

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Creative Commons BY-NC 3.0
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TREATMENT CROSSOVER (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

Engels

TREATMENT CROSSOVER (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulieren  
Patient administration
Beschrijving

Patient administration

Subject Number
Beschrijving

PT

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschrijving

PTINIT

Datatype

text

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

VDT

Datatype

date

Alias
UMLS CUI [1,1]
C1302584
TREATMENT CROSSOVER (UNSCHEDULED)
Beschrijving

TREATMENT CROSSOVER (UNSCHEDULED)

Did the subject participate in the treatment crossover plan?
Beschrijving

CROSSOVER_PARTICIPAT [CRSRPAR]

Datatype

boolean

Alias
UMLS CUI [1]
C0150097
Indicate the visit month at which the subject’s treatment crossover was implemented:
Beschrijving

If Yes:

Datatype

integer

Were both early crossover criteria listed below met?
Beschrijving

If the crossover visit month was prior to the Month 25 visit, complete the following: • Has lost >=10 letters on EDTRS BCVA from Baseline due to DME, as confirmed on >= 2 consecutive scheduled study visits, and • OCT images confirm persistent edema (CFT 250 μm) at the same visits.

Datatype

boolean

Alias
UMLS CUI [1]
C0242801
Indicate the reason why the subject did not participate in the treatment crossover:
Beschrijving

If No:

Datatype

integer

Alias
UMLS CUI [1]
C0680251
Other (specify):
Beschrijving

REASON_TREAT_CRSOVR [NCRSVR]

Datatype

text

Alias
UMLS CUI [1]
C0680251
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Similar models

TREATMENT CROSSOVER (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
TREATMENT CROSSOVER (UNSCHEDULED)
CROSSOVER_PARTICIPAT [CRSRPAR]
Item
Did the subject participate in the treatment crossover plan?
boolean
C0150097 (UMLS CUI [1])
TRT_CRSOVR_IMP_MTH [RXCOMO]
Item
Indicate the visit month at which the subject’s treatment crossover was implemented:
integer
ELIGIBILITY_CRITERIA [ELIGCR]
Item
Were both early crossover criteria listed below met?
boolean
C0242801 (UMLS CUI [1])
Item
Indicate the reason why the subject did not participate in the treatment crossover:
integer
C0680251 (UMLS CUI [1])
REASON_TREAT_CRSOVR [NCRSVR]
Code List
Indicate the reason why the subject did not participate in the treatment crossover:
CL Item
Subject has discontinued study treatment (1)
CL Item
Subject refused to participate in the treatment crossover plan (2)
CL Item
Other (specify): (3)
REASON_TREAT_CRSOVR [NCRSVR]
Item
Other (specify):
text
C0680251 (UMLS CUI [1])
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