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Adverse events

1 forms  
  1. StudyEvent: ODM
    1. Adverse events
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Number of AE
Description

Number of AE

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Adverse event (AE)
Description

Adverse event (AE)

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse event start date
Description

Adverse event start date

Data type

date

Alias
UMLS CUI [1]
C2697888
severity of AE
Description

severity of AE

Data type

integer

Alias
UMLS CUI [1]
C1710066
AE Action taken concerning therapy
Description

AE Action taken concerning therapy

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
AE study withdrawal
Description

AE study withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0422727
AE connected to study medication
Description

AE connected to study medication

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2930789
AE connected to AraC
Description

AE connected to AraC

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0010711
CTCAE-Grading
Description

CTCAE-Grading

Data type

integer

Alias
UMLS CUI [1]
C1516728
End of AE
Description

End of AE

Data type

date

Alias
UMLS CUI [1]
C2697886
AE continuous
Description

AE continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0549178
Adverse event course
Description

Adverse event course

Data type

integer

Alias
UMLS CUI [1]
C1705586
investigator signature
Description

investigator signature

Alias
UMLS CUI-1
C2346576
Date of investigator signature
Description

Date of investigator signature

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Adverse events

1 forms
  1. StudyEvent: ODM
    1. Adverse events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C0877248 (UMLS CUI-1)
Number of AE
Item
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Adverse event (AE)
Item
text
C0877248 (UMLS CUI [1])
Adverse event start date
Item
date
C2697888 (UMLS CUI [1])
Item
integer
C1710066 (UMLS CUI [1])
severity of AE
Code List
severity of AE
CL Item
 (0)
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Item
integer
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
AE Action taken concerning therapy
Code List
AE Action taken concerning therapy
CL Item
 (0)
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Item
text
C1519255 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
AE study withdrawal
Code List
AE study withdrawal
CL Item
 (j)
CL Item
 (n)
Item
text
C0877248 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
AE connection to study medication
Code List
AE connected to study medication
CL Item
 (j)
CL Item
 (n)
Item
text
C0877248 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
AE
Code List
AE connected to AraC
CL Item
 (j)
CL Item
 (n)
CTCAE-Grading
Item
integer
C1516728 (UMLS CUI [1])
End of AE
Item
date
C2697886 (UMLS CUI [1])
AE continuous
Item
boolean
C0877248 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
integer
C1705586 (UMLS CUI [1])
Adverse event course
Code List
Adverse event course
CL Item
 (0)
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Item Group
C2346576 (UMLS CUI-1)
Date of investigator signature
Item
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
text
C2346576 (UMLS CUI [1])
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