ID

28975

Description

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.

Mots-clés

Versions (1)
  1. 18/02/2018 18/02/2018 -
Détendeur de droits

Roche

Téléchargé le

18 février 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Study Completion/ Early Discontinuation rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g

Anglais

Study Completion/ Early Discontinuation

1 Formulaires  
STUDY COMPLETION / EARLY DISCONTINUATION
Description

STUDY COMPLETION / EARLY DISCONTINUATION

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0444930
Subject Number:
Description

Subject Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

Subject Initials

Type de données

text

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

Visit Date

Type de données

date

Alias
UMLS CUI [1]
C1320303
Did the subject complete the study through Month 24?
Description

Study Completion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0444930
If Yes, Date of Completion:
Description

Date of Completion

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0444930
If No, Date of Early Discontinuation from study:
Description

Date of Early Discontinuation

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2718058
PRIMARY reason the subject discontinued early from the study
Description

reason

Type de données

text

Alias
UMLS CUI [1]
C0392360
Please specify intervention:
Description

Concomitant Therapy

Type de données

text

Alias
UMLS CUI [1]
C1707479
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Similar models

Study Completion/ Early Discontinuation

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
STUDY COMPLETION / EARLY DISCONTINUATION
C0008976 (UMLS CUI-1)
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])
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])
Date of Completion
Item
If Yes, Date of Completion:
date
C0011008 (UMLS CUI [1,1])
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])
Item
PRIMARY reason the subject discontinued early from the study
text
C0392360 (UMLS CUI [1])
reason
Code List
PRIMARY reason the subject discontinued early from the study
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)
CL Item
Adverse Event (complete appropriate AE CRF) (Adverse Event (complete appropriate AE CRF))
C0877248 (UMLS CUI-1)
(Comment:en)
CL Item
Lost to follow-up (Lost to follow-up)
C1302313 (UMLS CUI-1)
(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)
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)
CL Item
Sponsor’s decision to terminate study (Sponsor’s decision to terminate study)
C1710224 (UMLS CUI-1)
(Comment:en)
CL Item
Subject non-compliance (Subject non-compliance)
C0457432 (UMLS CUI-1)
(Comment:en)
CL Item
Subject’s condition mandated other therapeutic intervention. (Subject’s condition mandated other therapeutic intervention.)
C1707479 (UMLS CUI-1)
(Comment:en)
Concomitant Therapy
Item
Please specify intervention:
text
C1707479 (UMLS CUI [1])
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