ID

29016

Beschreibung

Study part: Serious Adverse Event Reporting. 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.

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Versionen (1)
  1. 20.02.18 20.02.18 -
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Roche

Hochgeladen am

20. Februar 2018

DOI

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Creative Commons BY-NC 3.0
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Serious Adverse Event Reporting rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g

Englisch

Serious Adverse Event Reporting

1 Formulare  
SERIOUS ADVERSE EVENT REPORTING
Beschreibung

SERIOUS ADVERSE EVENT REPORTING

Alias
UMLS CUI-1
C1519255
Subject Number:
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschreibung

Subject Initials

Datentyp

text

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

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
PRIMARY SERIOUS ADVERSE EVENT
Beschreibung

Adverse event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Ocular AEs Only Indicate Eye Affected
Beschreibung

eye

Datentyp

text

Alias
UMLS CUI [1]
C0015392
ONSET
Beschreibung

Onset

Datentyp

date

Alias
UMLS CUI [1]
C0574845
RESOLUTION
Beschreibung

end date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Check if event is ongoing
Beschreibung

adverse event ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826663
SAE INTENSITY
Beschreibung

Adverse Event intensity

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
SAE SUSPECTED TO BE CAUSED BY STUDY DRUG?
Beschreibung

cause of adverse event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0877248
OTHER SUSPECTED CAUSES OF SAE
Beschreibung

cause of adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0877248
ACTION TAKEN WITH STUDY DRUG DUE TO AE
Beschreibung

Action taken

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
TREATMENT FOR AE
Beschreibung

adverse event therapy

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was the subject hospitalized due to serious AE?
Beschreibung

Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0019993
If Yes, Admission Date:
Beschreibung

Admission date

Datentyp

date

Alias
UMLS CUI [1]
C1302393
The primary Adverse Event was considered serious because
Beschreibung

reason

Datentyp

integer

Alias
UMLS CUI [1]
C0566251
Date of Death:
Beschreibung

Date of Death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Autopsy performed?
Beschreibung

Autopsy

Datentyp

text

Alias
UMLS CUI [1]
C0004398
Relevant Diagnostic Tests Performed (To diagnose or confirm primary SAE):
Beschreibung

Relevant Diagnostic Tests Performed (To diagnose or confirm primary SAE):

Alias
UMLS CUI-1
C0086143
Relevant Diagnostic Tests performed?
Beschreibung

Diagnostic tests

Datentyp

boolean

Alias
UMLS CUI [1]
C0086143
Relevant Diagnostic Test
Beschreibung

Diagnostic tests

Datentyp

text

Alias
UMLS CUI [1]
C0086143
Date Performed
Beschreibung

Date Performed

Datentyp

date

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0011008
Relevant Diagnostic Test Result
Beschreibung

test result

Datentyp

text

Alias
UMLS CUI [1]
C0456984
Result Pending
Beschreibung

test result

Datentyp

boolean

Alias
UMLS CUI [1]
C0456984
Additional Case Details:
Beschreibung

• Associated signs and symptoms, if applicable • Clinical course (e.g. sequence of events) • Elaborate on suspected causes of SAE • Any specific treatment for the SAE

Datentyp

text

Alias
UMLS CUI [1]
C1546922
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Ähnliche Modelle

Serious Adverse Event Reporting

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
SERIOUS ADVERSE EVENT REPORTING
C1519255 (UMLS CUI-1)
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])
Adverse event
Item
PRIMARY SERIOUS ADVERSE EVENT
text
C0877248 (UMLS CUI [1])
Item
Ocular AEs Only Indicate Eye Affected
text
C0015392 (UMLS CUI [1])
eye
Code List
Ocular AEs Only Indicate Eye Affected
CL Item
Right (Right)
C0229089 (UMLS CUI-1)
(Comment:en)
CL Item
Left (Left)
C0229090 (UMLS CUI-1)
(Comment:en)
Onset
Item
ONSET
date
C0574845 (UMLS CUI [1])
end date
Item
RESOLUTION
date
C0806020 (UMLS CUI [1])
adverse event ongoing
Item
Check if event is ongoing
boolean
C2826663 (UMLS CUI [1])
Item
SAE INTENSITY
integer
C1710066 (UMLS CUI [1])
Adverse Event intensity
Code List
SAE INTENSITY
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
cause of adverse event
Item
SAE SUSPECTED TO BE CAUSED BY STUDY DRUG?
boolean
C0015127 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
OTHER SUSPECTED CAUSES OF SAE
integer
C0015127 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
cause of advese event
Code List
OTHER SUSPECTED CAUSES OF SAE
CL Item
None  (1)
C0549184 (UMLS CUI-1)
(Comment:en)
CL Item
Disease Under Study (2)
C0012634 (UMLS CUI-1)
(Comment:en)
CL Item
Withdrawal of Study Drug (3)
C2349954 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
(Comment:en)
CL Item
Concurrent Illness (4)
C0009488 (UMLS CUI-1)
(Comment:en)
CL Item
Concurrent Medication (5)
C2347852 (UMLS CUI-1)
(Comment:en)
CL Item
Non-Drug Intervention (6)
C3661844 (UMLS CUI-1)
(Comment:en)
CL Item
Treatment Procedure (7)
C0087111 (UMLS CUI-1)
(Comment:en)
Item
ACTION TAKEN WITH STUDY DRUG DUE TO AE
integer
C2826626 (UMLS CUI [1])
Action taken
Code List
ACTION TAKEN WITH STUDY DRUG DUE TO AE
CL Item
None (1)
CL Item
Drug permanently discontinued (2)
CL Item
Dose held (3)
CL Item
Not applicable (4)
Item
TREATMENT FOR AE
integer
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
adverse event therapy
Code List
TREATMENT FOR AE
CL Item
None (1)
CL Item
Medication (2)
CL Item
Procedure/ Surgery (3)
CL Item
Subject DC from study (4)
Hospitalization
Item
Was the subject hospitalized due to serious AE?
boolean
C0019993 (UMLS CUI [1])
Admission date
Item
If Yes, Admission Date:
date
C1302393 (UMLS CUI [1])
Item
The primary Adverse Event was considered serious because
integer
C0566251 (UMLS CUI [1])
reason
Code List
The primary Adverse Event was considered serious because
CL Item
It resulted in death (1)
C1306577 (UMLS CUI-1)
(Comment:en)
CL Item
It was life-threatening (i.e., the recorded AE placed subject at immediate risk of death) (2)
C2826244 (UMLS CUI-1)
(Comment:en)
CL Item
It required or prolonged inpatient hospitalization (i.e., the recorded AE caused the subject to behospitalized or prolonged hospitalization beyond the expected length of stay) (3)
C0019993 (UMLS CUI-1)
(Comment:en)
CL Item
It was disabling (i.e., the recorded AE resulted in substantial disruption of the subject’s ability to carry out normal life functions) (4)
C4061999 (UMLS CUI-1)
(Comment:en)
CL Item
It is a congenital anomaly/birth defect in offspring of study subject (5)
C0000768 (UMLS CUI-1)
(Comment:en)
CL Item
It does not meet any of the above serious criteria, but may jeopardize the subject, and may require medical or surgical intervention to prevent one of the outcomes listed above. (6)
C0184661 (UMLS CUI-1)
(Comment:en)
Date of Death
Item
Date of Death:
date
C1148348 (UMLS CUI [1])
Item
Autopsy performed?
text
C0004398 (UMLS CUI [1])
Autopsy
Code List
Autopsy performed?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item Group
Relevant Diagnostic Tests Performed (To diagnose or confirm primary SAE):
C0086143 (UMLS CUI-1)
Diagnostic tests
Item
Relevant Diagnostic Tests performed?
boolean
C0086143 (UMLS CUI [1])
Diagnostic tests
Item
Relevant Diagnostic Test
text
C0086143 (UMLS CUI [1])
Date Performed
Item
Date Performed
date
C0430022 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
test result
Item
Relevant Diagnostic Test Result
text
C0456984 (UMLS CUI [1])
test result
Item
Result Pending
boolean
C0456984 (UMLS CUI [1])
additional information
Item
Additional Case Details:
text
C1546922 (UMLS CUI [1])
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