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Non-Serious Adverse Events Form

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

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

Non-serious Adverse Event

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

If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form. If Yes, record details below.

Data type

text

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event
Description

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Event (diagnosis only, otherwise sign/symptom)
Description

Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator.

Data type

text

Alias
UMLS CUI [1]
C1518404
Start Date
Description

Day onth Year Record the start date of the first occurrence of the AE.

Data type

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0877248
Start Time
Description

Hr : Min 00:00-23:59 Record the start time of the AE.

Data type

time

Alias
UMLS CUI [1]
C1301880
Outcome
Description

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

Data type

integer

Alias
UMLS CUI [1]
C1705586
End Date
Description

Day Month Year Record the end date. This is the date the AE Recovered/Resolved. If the event Recovered/Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the AE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

Data type

text

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0877248
Maximum Intensity
Description

Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with normal everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

Data type

integer

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

Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occured. Dose interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or post-dosing).

Data type

integer

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

Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’.

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
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 or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent 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
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Similar models

Non-Serious Adverse Events Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Non-serious Adverse Event
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 Event
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Event
Item
Event (diagnosis only, otherwise sign/symptom)
text
C1518404 (UMLS CUI [1])
Start Date
Item
Start Date
text
C0808070 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C1301880 (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
Item
End Date
text
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious 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
Dose interrupted (5)
CL Item
Not applicable (6)
Item
Did the subject withdraw from study as a result of this AE?
text
C0877248 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Withdrawal
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])
Relationship to investigational products
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)
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