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Non-Serious Adverse Events

1 forms  
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Description

Any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. For GSK clinical studies, AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e., invasive procedures, modification of subject’s previous therapeutic regimen). If yes, fill in the other items of this itemgroup.

Data type

text

Alias
UMLS CUI [1]
C1518404
Diagnosis only (if known) or signs/symptoms (list one per line).
Description

Enter only the diagnosis (if known); otherwise each sign and symptom should be entered on a separate line. If a diagnosis subsequently becomes available, then this should be entered and the signs and symptoms crossed out.

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C1457887
Date of onset
Description

Record the date of onset of the first occurrence of the AE.

Data type

date

Alias
UMLS CUI [1]
C2985916
Record the maximum intensity that occurred over the duration of the event.
Description

Amend the intensity if it increases.

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Outcome
Description

All AEs must be followed until the events are resolved, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Resolved" or "Resolved with sequelae". If the adverse event is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as "Not resolved". Also enter "Not resolved" if the AE was ongoing at the time of death, but was not the cause of death.

Data type

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Record the date of resolution.
Description

This is the last date of occurrence of the AE. If the event resolved with sequelae, enter the date the subject’s medical condition stabilized. Leave blank if the AE is "Not resolved".

Data type

date

Alias
UMLS CUI [1]
C2985918
Action Taken with Investigational Product(s) as a result of the Non-Serious Adverse Event
Description

Indicate only for the specific event(s) that were directly responsible for the action taken with investigational product(s): None = Investigational product(s) continue(s) even though an adverse event has occurred. Dose adjusted = Dose is increased or decreased for one or more investigational product(s). Temporarily interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Permanently discontinued = Administration of one or more investigational product(s) was stopped permanently and not restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or postdosing).

Data type

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this non-serious AE?
Description

Indicate only the event(s) directly responsible for the subject’s withdrawal as indicated on the End of Study Record form.

Data type

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
Description

It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. "A reasonable possibility" is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence/arguments that may support "A reasonable possibility" include, for example, a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concomitant illness, or relevant medical history, should also be considered.

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Does the AE meet the definition of serious?
Description

If YES, fill out the serious adverse event form instead.

Data type

text

Alias
UMLS CUI [1]
C1710056
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Similar models

Non-Serious Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Events
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Non-Serious Adverse Event
Item
Diagnosis only (if known) or signs/symptoms (list one per line).
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Date of onset
Item
Date of onset
date
C2985916 (UMLS CUI [1])
Item
Record the maximum intensity that occurred over the duration of the event.
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Maximum Intensity
Code List
Record the maximum intensity that occurred over the duration of the event.
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved (R)
CL Item
Resolved with Sequelae (S)
CL Item
Not Resolved (N)
Date of Resolution
Item
Record the date of resolution.
date
C2985918 (UMLS CUI [1])
Item
Action Taken with Investigational Product(s) as a result of the Non-Serious Adverse Event
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product(s) as a result of the Non-Serious Adverse Event
Code List
Action Taken with Investigational Product(s) as a result of the Non-Serious Adverse Event
CL Item
None (0)
CL Item
Dose adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permantently discontinued (3)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this non-serious AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Did the subject withdraw from study as a result of this non-serious AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
text
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Non-Serious Adverse Events
Code List
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the AE meet the definition of serious?
text
C1710056 (UMLS CUI [1])
Non-Serious Adverse Events
Code List
Does the AE meet the definition of serious?
CL Item
Yes (Y)
CL Item
No (N)
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