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Adverse Events

11 forms  
Common
Description

Common

Alias
TEST
Common ItemGroup Alias
Site number
Description

Site Number as assigned by CRO

Data type

integer

Alias
SDTM
SITEID
Subject ID
Description

Subject ID

Data type

text

Alias
SDTM
USUBJID
Visit Date
Description

Visit Date

Data type

date

Visit Start Time
Description

Visit Time

Data type

time

Adverse events
Description

Adverse events

Has the subject experienced any adverse events
Description

Adverse Event Experienced

Data type

integer

Adverse events
Description

Adverse events

Event No.
Description

Adverse Event Number

Data type

integer

Adverse event
Description

Adverse Event Term

Data type

text

Start Date
Description

Adverse Event Start Date

Data type

date

Is the adverse event still continuing
Description

Adverse Event Continues

Data type

integer

Stop Date
Description

Adverse Event Stop Date

Data type

date

Duration of the adverse event
Description

AE duration

Data type

durationDatetime

Was event serious
Description

Adverse Event Serious

Data type

integer

Severity
Description

Adverse Event Severity

Data type

integer

Action taken with study drug
Description

Adverse Event Action Taken

Data type

integer

Subject outcome
Description

Adverse Event Subject Outcome

Data type

integer

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Similar models

Adverse Events

11 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Common
Common ItemGroup Alias (TEST)
Site Number
Item
Site number
integer
SITEID (SDTM)
Subject ID
Item
Subject ID
text
USUBJID (SDTM)
Visit Date
Item
Visit Date
date
Visit Time
Item
Visit Start Time
time
Item Group
Adverse events
Item
Has the subject experienced any adverse events
integer
No Yes
Code List
Has the subject experienced any adverse events
CL Item
No (0)
CL Item
Yes (1)
Item Group
Adverse events
Adverse Event Number
Item
Event No.
integer
Adverse Event Term
Item
Adverse event
text
Adverse Event Start Date
Item
Start Date
date
Item
Is the adverse event still continuing
integer
No Yes
Code List
Is the adverse event still continuing
CL Item
No (0)
CL Item
Yes (1)
Adverse Event Stop Date
Item
Stop Date
date
AE duration
Item
Duration of the adverse event
durationDatetime
Item
Was event serious
integer
No Yes
Code List
Was event serious
CL Item
No (0)
CL Item
Yes (1)
Item
Severity
integer
Adverse Event Severity
Code List
Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Is there a reasonable possibility that the AE may have been caused by the study drug
integer
No Yes
Code List
Is there a reasonable possibility that the AE may have been caused by the study drug
CL Item
No (0)
CL Item
Yes (1)
Item
Action taken with study drug
integer
Adverse Event Action Taken
Code List
Action taken with study drug
CL Item
None (1)
CL Item
Study drug regimen changed (2)
CL Item
Temporarily stopped study drug (3)
CL Item
Study drug discontinued (4)
Item
Subject outcome
integer
Adverse Event Action Taken
Code List
Subject outcome
CL Item
Subject remains in study (1)
CL Item
Withdrawn from study (2)
CL Item
Lost to follow-up (3)
CL Item
Death (4)
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