Englisch

Screen Failure Log: Adverse Events [AE_1] NCT01117584

1 Formulare  
General Information
Beschreibung

General Information

Was any adverse event reported or observed?
Beschreibung

Any Adverse Event

Datentyp

boolean

Adverse Event
Beschreibung

Adverse Event

Datentyp

text

Onset Date
Beschreibung

Onset Date

Datentyp

date

End Date
Beschreibung

End Date

Datentyp

date

Outcome
Beschreibung

Outcome

Datentyp

text

Course of Event
Beschreibung

Course of Event

Datentyp

text

Severity
Beschreibung

Severity

Datentyp

text

Serious AE?
Beschreibung

If Seriousness is "yes", tick all that apply.

Datentyp

boolean

Serious AE Number
Beschreibung

Serious AE Number

Datentyp

integer

Death
Beschreibung

Death

Datentyp

boolean

Requires or prolongs hospitalization
Beschreibung

Requires or prolongs hospitalization

Datentyp

boolean

Congenital anomaly
Beschreibung

Congenital anomaly

Datentyp

boolean

Life-threatening
Beschreibung

Life-threatening

Datentyp

boolean

Persistent or significant disability/incapacity
Beschreibung

Disability

Datentyp

boolean

Other medical importance
Beschreibung

Medical Importance

Datentyp

boolean

Action Taken for Study Drug
Beschreibung

Action Taken for Study Drug

Datentyp

text

Was there any treatment required?
Beschreibung

If Yes, please select all that apply.

Datentyp

boolean

Medication Therapy
Beschreibung

Medication Therapy

Datentyp

boolean

Non-Medication Therapy
Beschreibung

Non-Medication Therapy

Datentyp

boolean

Relationship to Study Drug
Beschreibung

Relationship to Study Drug

Datentyp

text

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Screen Failure Log: Adverse Events [AE_1] NCT01117584

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
Any Adverse Event
Item
Was any adverse event reported or observed?
boolean
Adverse Event
Item
Adverse Event
text
Onset Date
Item
Onset 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)
CL Item
Fatal (5)
CL Item
Unknown (6)
Item
Course of Event
text
Course of Event
Code List
Course of Event
CL Item
Single Episode (1)
CL Item
Intermittent (2)
CL Item
Continous (3)
Item
Severity
text
Severity
Code List
Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Serious AE
Item
Serious AE?
boolean
Serious AE Number
Item
Serious AE Number
integer
Death
Item
Death
boolean
Requires or prolongs hospitalization
Item
Requires or prolongs hospitalization
boolean
Congenital anomaly
Item
Congenital anomaly
boolean
Life-threatening
Item
Life-threatening
boolean
Disability
Item
Persistent or significant disability/incapacity
boolean
Medical Importance
Item
Other medical importance
boolean
Item
Action Taken for Study Drug
text
Action Taken for Study Drug
Code List
Action Taken for Study Drug
CL Item
Dose Not Changed (1)
CL Item
Drug Interrupted (2)
CL Item
Drug Withdrawn  (3)
CL Item
Not Applicable (4)
CL Item
Unknown (5)
Treatment
Item
Was there any treatment required?
boolean
Medication Therapy
Item
Medication Therapy
boolean
Non-Medication Therapy
Item
Non-Medication Therapy
boolean
Item
Relationship to Study Drug
text
Relationship to Study Drug
Code List
Relationship to Study Drug
CL Item
Not Related (1)
CL Item
Possible (2)
CL Item
Probable (3)
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