Information:
Fel:
ID
28975
Beskrivning
Study part: Study Completion/ Early Discontinuation. A Phase III, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) In Subjects With Minimally Classic Or Occult Subfoveal Neovascular Age-Related Macular Degeneration.
Nyckelord
Versioner (1)
- 2018-02-18 2018-02-18 -
Rättsinnehavare
Roche
Uppladdad den
18 februari 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Study Completion/ Early Discontinuation rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g
Study Completion/ Early Discontinuation
- StudyEvent: ODM
Similar models
Study Completion/ Early Discontinuation
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
STUDY COMPLETION / EARLY DISCONTINUATION
C0008976 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
C0444930 (UMLS CUI-2)
Subject Number
Item
Subject Number:
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
Visit Date
Item
Visit Date:
date
C1320303 (UMLS CUI [1])
Study Completion
Item
Did the subject complete the study through Month 24?
boolean
C0008976 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,2])
Date of Completion
Item
If Yes, Date of Completion:
date
C0011008 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,2])
Date of Early Discontinuation
Item
If No, Date of Early Discontinuation from study:
date
C0011008 (UMLS CUI [1,1])
C2718058 (UMLS CUI [1,2])
C2718058 (UMLS CUI [1,2])
Item
PRIMARY reason the subject discontinued early from the study
text
C0392360 (UMLS CUI [1])
CL Item
Death (complete Death Report and SAE CRF as appropriate) (Death (complete Death Report and SAE CRF as appropriate))
C0011065 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Adverse Event (complete appropriate AE CRF) (Adverse Event (complete appropriate AE CRF))
C0877248 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Lost to follow-up (Lost to follow-up)
C1302313 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Subject’s decision to withdraw (for reasons other than AE) (Subject’s decision to withdraw (for reasons other than AE))
C0422727 (UMLS CUI-1)
C0679006 (UMLS CUI-2)
(Comment:en)
C0679006 (UMLS CUI-2)
(Comment:en)
CL Item
Physician’s decision to withdraw (for reasons other than AE) (Physician’s decision to withdraw (for reasons other than AE))
C1709536 (UMLS CUI-1)
C2348571 (UMLS CUI-2)
(Comment:en)
C2348571 (UMLS CUI-2)
(Comment:en)
CL Item
Sponsor’s decision to terminate study (Sponsor’s decision to terminate study)
C1710224 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Subject non-compliance (Subject non-compliance)
C0457432 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Subject’s condition mandated other therapeutic intervention. (Subject’s condition mandated other therapeutic intervention.)
C1707479 (UMLS CUI-1)
(Comment:en)
(Comment:en)
Concomitant Therapy
Item
Please specify intervention:
text
C1707479 (UMLS CUI [1])
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