ID

23263

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 #: 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

Trefwoorden

Versies (1)
  1. 01-07-17 01-07-17 -
Houder van rechten

Genentech, Inc.

Geüploaded op

1 juli 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

Engels

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

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
STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
Beschrijving

STUDY COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)

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

DISC_COMPLETED_STUDY [DCCMP]

Datatype

integer

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

DISC_COMP_DT [DCCDT]

Datatype

date

Maateenheden
  • 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):
Beschrijving

DISC_PRIMARY_REASON [DCRS]

Datatype

integer

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

DISC_PRIMARY_REAS_SP [DCRSP]

Datatype

text

Alias
UMLS CUI [1,1]
C2348571
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0184661
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Similar models

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

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
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])
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