Englisch

Non-Serious Adverse Event Form

1 Formulare  
Non-Serious Adverse Event (AE)
Beschreibung

Non-Serious Adverse Event (AE)

Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Modified Term
Beschreibung

Modified Term

Datentyp

text

Start Date
Beschreibung

Start Date

Datentyp

date

End Date
Beschreibung

End Date

Datentyp

date

Outcome
Beschreibung

Outcome

Datentyp

text

Frequency
Beschreibung

Frequency

Datentyp

text

Maximum Intensity
Beschreibung

Record maximum intensity throughout duration of event

Datentyp

text

Intensity at onset of event
Beschreibung

Intensity at onset of event

Datentyp

text

Maximum Grade
Beschreibung

Maximum Grade

Datentyp

text

Grade at onset of event
Beschreibung

Grade at onset of event

Datentyp

text

Maximum Grade or Intensity
Beschreibung

Maximum Grade or Intensity

Datentyp

text

Grade or Intensity at onset of event
Beschreibung

Grade or Intensity at onset of event

Datentyp

text

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

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

Datentyp

text

Did the subject withdraw from study as a result of this AE?
Beschreibung

Did the subject withdraw from study as a result of this AE?

Datentyp

boolean

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Ue best judgement at initial entry. May be amended when additional information becomes available.

Datentyp

boolean

Duration of AE if < 24 hours
Beschreibung

HH:MM

Datentyp

integer

Time to Onset Since Last Dose
Beschreibung

Time to Onset Since Last Dose

Datentyp

time

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Ähnliche Modelle

Non-Serious Adverse Event Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-Serious Adverse Event (AE)
Sequence Number
Item
Sequence Number
integer
Event
Item
Event
text
Modified Term
Item
Modified Term
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Item
Outcome
text
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)
Item
Frequency
text
Frequency
Code List
Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
Maximum Intensity
Code List
Maximum Intensity
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
CL Item
[X] Not applicable (4)
Item
Intensity at onset of event
text
Intensity at onset of event
Code List
Intensity at onset of event
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
CL Item
[X] Not applicable (4)
Item
Maximum Grade
text
Maximum Grade
Code List
Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Grade at onset of event
text
Grade at onset of event
Code List
Grade at onset of event
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)
Item
Maximum Grade or Intensity
text
Maximum Grade or Intensity
Code List
Maximum Grade or Intensity
CL Item
[1] Mild or Grade 1 (1)
CL Item
[2] Moderate or Grade 2 (2)
CL Item
[3] Severe or Grade 3 (3)
CL Item
[4] Grade 4 (4)
CL Item
[5] Grade 5 (5)
CL Item
[X] Not applicable (6)
Item
Grade or Intensity at onset of event
text
Grade or Intensity at onset of event
Code List
Grade or Intensity at onset of event
CL Item
[1] Mild or Grade 1 (1)
CL Item
[2] Moderate or Grade 2 (2)
CL Item
[3] Severe or Grade 3 (3)
CL Item
[4] Grade 4 (4)
CL Item
[5] Grade 5 (5)
CL Item
[X] Not applicable (6)
Item
Action Taken with Investigational Product(s) as a result of the AE
text
Action Taken with Investigational Product(s) as a result of the AE
Code List
Action Taken with Investigational Product(s) as a result of the AE
CL Item
[1] Investigational product(s) withdrawn (1)
CL Item
[2] Dose reduced (2)
CL Item
[3] Dose increased (3)
CL Item
[4] Dose not changed (4)
CL Item
[5] Dose interrupted (5)
CL Item
[X] Not applicable (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
integer
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
time
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