Englisch

Non-Serious Adverse Event

1 Formulare  
Non-serious adverse event
Beschreibung

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
1. Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
2. Event
Beschreibung

Diagnosis Only (if known) Otherwise Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1]
C1518404
3. Modified term
Beschreibung

Modified term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beschreibung

MedDRA synonym

Datentyp

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschreibung

MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1518404
4. Start Date Non-serious adverse event
Beschreibung

Start Date Non-serious adverse event

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2697888
5. Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
5. End date Non-serious adverse event
Beschreibung

If outcome "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date.

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2697886
6. Frequency Non-serious adverse event
Beschreibung

Frequency Non-serious adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
7. Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C1518404
8. Maximum Grade Non-serious adverse event
Beschreibung

Maximum Grade Non-serious adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C2985911
UMLS CUI [1,2]
C1518404
9. Maximum Grade or Intensity
Beschreibung

Maximum Grade or Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C1518404
10. Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

Action Taken with Investigational Product

Datentyp

integer

Alias
UMLS CUI [1]
C1704758
11. Did the subject withdraw from study as a result of this AE?
Beschreibung

Withdrawal from study

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
12 Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

AE caused by investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1518404
13. Duration of AE if < 24 hours (hours)
Beschreibung

If AE start and end time are used this item must be hidden.

Datentyp

integer

Maßeinheiten
  • Hr(s)
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449238
Hr(s)
13. Duration of AE if < 24 hours (minutes)
Beschreibung

If AE start and end time are used this item must be hidden.

Datentyp

integer

Maßeinheiten
  • min(s)
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449238
min(s)
14. Time to Onset Since Last Dose (hours)
Beschreibung

Time to Onset Since Last Dose hours

Datentyp

integer

Maßeinheiten
  • Hr(s)
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
Hr(s)
14. Time to Onset Since Last Dose (minutes)
Beschreibung

Time to Onset Since Last Dose minutes

Datentyp

integer

Maßeinheiten
  • min(s)
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
min(s)
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Ähnliche Modelle

Non-Serious Adverse Event

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-serious adverse event
C1518404 (UMLS CUI-1)
Sequence Number
Item
1. Sequence Number
integer
C2348184 (UMLS CUI [1])
Non-serious adverse event
Item
2. Event
text
C1518404 (UMLS CUI [1])
Modified term
Item
3. Modified term
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start Date Non-serious adverse event
Item
4. Start Date Non-serious adverse event
date
C1518404 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Item
5. Outcome
integer
C1705586 (UMLS CUI [1])
Outcome / End Date
Code List
5. Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
(Comment:en)
CL Item
Recovering/Resolving (2)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
(Comment:en)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
(Comment:en)
End date Non-serious adverse event
Item
5. End date Non-serious adverse event
date
C1518404 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Item
6. Frequency Non-serious adverse event
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency
Code List
6. Frequency Non-serious adverse event
CL Item
Single Episode (1)
(Comment:en)
CL Item
Intermittent (2)
(Comment:en)
Item
7. Maximum Intensity
integer
C1710066 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity
Code List
7. Maximum Intensity
CL Item
Mild (1)
(Comment:en)
CL Item
Moderate (2)
(Comment:en)
CL Item
Severe (3)
(Comment:en)
CL Item
Not applicable (4)
(Comment:en)
Item
8. Maximum Grade Non-serious adverse event
integer
C2985911 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity
Code List
8. Maximum Grade Non-serious adverse event
CL Item
Grade I (1)
(Comment:en)
CL Item
Grade 2 (2)
(Comment:en)
CL Item
Grade 3 (3)
(Comment:en)
CL Item
Grade4 (4)
(Comment:en)
CL Item
Grade 5 (5)
(Comment:en)
CL Item
Not applicable  (6)
(Comment:en)
Item
9. Maximum Grade or Intensity
integer
C1710066 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Grade
Code List
9. Maximum Grade or Intensity
CL Item
Mild or Grade I (1)
(Comment:en)
CL Item
Moderate or Grade 2 (2)
(Comment:en)
CL Item
Severe or Grade 3 (3)
(Comment:en)
CL Item
Grade4 (4)
(Comment:en)
CL Item
Grade 5 (5)
(Comment:en)
CL Item
Not applicable  (6)
(Comment:en)
Item
10. Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
10. Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
(Comment:en)
CL Item
Dose reduced (2)
(Comment:en)
CL Item
Dose increased (3)
(Comment:en)
CL Item
Dose not changed (4)
(Comment:en)
CL Item
Dose interrupted (5)
(Comment:en)
CL Item
Not applicable (6)
(Comment:en)
Withdrawal from study
Item
11. Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1])
AE caused by investigational product
Item
12 Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0013230 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Duration of AE hours
Item
13. Duration of AE if < 24 hours (hours)
integer
C1518404 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of AE minutes
Item
13. Duration of AE if < 24 hours (minutes)
integer
C1518404 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose hours
Item
14. Time to Onset Since Last Dose (hours)
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Time to Onset Since Last Dose minutes
Item
14. Time to Onset Since Last Dose (minutes)
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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