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Non-Serious Adverse Events (AE)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Non-serious Adverse Event
Description

Non-serious Adverse Event

Alias
UMLS CUI-1
C1518404
Sequence Number
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0877248
Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C1518404
Modified term
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C0877248
MedDRA synonym
Description

In the original form this item is hidden.

Data type

boolean

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C0877248
MedDRA lower level term code
Description

In the original form this item is hidden.

Data type

boolean

Alias
UMLS CUI [1,1]
C3898442
UMLS CUI [1,2]
C0877248
Failed coding
Description

In the original form this item is hidden.

Data type

boolean

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C0877248
Start Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2697888
Outcome
Description

If you tick "Recovered/Resolved" or "Recovered/Resolved with sequelae" provide End Date and Time

Data type

integer

Alias
UMLS CUI [1]
C1705586
End Date and Time
Description

End Date and Time of AE

Data type

datetime

Alias
UMLS CUI [1]
C2826793
Frequency of AE
Description

Frequency of AE

Data type

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1518404
Maximum Intensity
Description

This item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" item has been used.

Data type

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Maximum Grade
Description

This item may be hidden if either the "Maximum Intensity" or "Maximum Grade or Intensity" item has been used Grade 5 is optional.

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
Maximum Grade or Intensity
Description

This item may be hidden if either the "Maximum Intensity" or "Maximum Grade" item has been used Grade 5 is optional.

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C0877248
Action Taken with Investigational Product(s) as a Result of the AE
Description

Action Taken with Investigational Product(s) as a Result of the AE

Data type

text

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this AE?
Description

Patient withdrawn due to this AE

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship to Investigational Drug

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Duration of AE if < 24 hours
Description

If AE start and end time are used this item must be hidden. Hr(s), min(s)

Data type

float

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to Onset Since Last Dose
Description

In the original form this item is hidden. Hr(s), min(s)

Data type

float

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C1517741
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Similar models

Non-Serious Adverse Events (AE)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-serious Adverse Event
C1518404 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Non-serious Adverse Event
Item
Event
text
C1518404 (UMLS CUI [1])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
MedDRA synonym
Item
MedDRA synonym
boolean
C1140263 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
boolean
C3898442 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Failed coding
Item
Failed coding
boolean
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Start Date of AE
Item
Start Date
date
C2697888 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date and Time of AE
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Frequency of AE
integer
C0439603 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Frequency of AE
Code List
Frequency of AE
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Maximum Grade
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Maximum Grade of AE
Code List
Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Maximum Grade or Intensity
text
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
Maximum Grade or Intensity of AE
Code List
Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C2826626 (UMLS CUI [1])
Action Taken with Respect to Investigational Drug
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Drug interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Patient withdrawn due to this AE
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Patient withdrawn due to this AE
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Duration of AE
Item
Duration of AE if < 24 hours
float
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
float
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
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