Anglais

Non-Serious Adverse Events

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Session Number
Description

Session Number

Type de données

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
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

If YES, indicate following items. 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.

Type de données

text

Alias
UMLS CUI [1]
C1518404
Non-serious adverse event, Diagnosis
Description

Diagnosis only (if known) signs / symptoms (list one per line). 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.

Type de données

text

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

day month year. Record the date of onset of the first occurrence of the AE .

Type de données

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1518404
Time of onset
Description

00:00-23:59 Record the exact time of onset of the AE.

Type de données

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1518404
Maximum intensity
Description

Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases.

Type de données

text

Alias
UMLS CUI [1]
C1710066
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.

Type de données

text

Alias
UMLS CUI [1]
C1705586
Date of resolution
Description

day month year. Record the date of resolution. This is the last date of occurrence of the AE. If the event resolved with sequelae, enter the date the subject's medical cond ition stabilized. Leave blank if the AE is "Not resolved".

Type de données

date

Alias
UMLS CUI [1]
C2985918
Time of resolution
Description

00:00-23:59 Record the exact lime of resolution of the AE.

Type de données

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C1518404
Action taken with investigational Relationship product(s) as a result of the non-serious AE
Description

Indicate only for the specific event(s) that were directly responsible for the action taken with investigational product(s): None: lnvestigational product(s) continue(s) even though an adverse event has occurred. Dose adjusted: Dose is increased or decreased for one or more investigation al product(s). Temporarily interrupted: Administration of one or more invesligational product(s) was stopped temporarily but then restarted. Permanently discontinued: Administration of one or more investigalional 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).

Type de données

text

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

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

Type de données

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility the non-serious AE may have been caused by the investigational product(s)?
Description

II is a regulatory requirement for investigators lo assess relationship lo invesligalional 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.

Type de données

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Does the AE meet the definition of serious?
Description

If you tick YES, fill in the SAE form!

Type de données

text

Alias
UMLS CUI [1]
C1710056
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Similar models

Non-Serious Adverse Events

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Session Number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session Number
Code List
Session Number
CL Item
Session 1 (1)
CL Item
Session 2 (2)
CL Item
Session 3 (3)
CL Item
Session 4 (4)
CL Item
Session 5 (5)
CL Item
Session 6 (6)
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 Event
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, Diagnosis
Item
Non-serious adverse event, Diagnosis
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time of onset
Item
Time of onset
time
C0449244 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1710066 (UMLS CUI [1])
Maximum intensity
Code List
Maximum intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe with  (3)
CL Item
Not applicable (X)
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (R)
CL Item
Resolved with sequelae (S)
CL Item
Not resolved (N)
Date of resolution
Item
Date of resolution
date
C2985918 (UMLS CUI [1])
Time of resolution
Item
Time of resolution
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Action taken with investigational Relationship product(s) as a result of the non-serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Investigational product(s) as a result of the non-serious AE
Code List
Action taken with investigational Relationship product(s) as a result of the non-serious AE
CL Item
None (0)
CL Item
Dose adjusted  (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued  (3)
CL Item
Not applicable (X)
Item
Did subject withdraw from study as a result of non-serious AE?
text
C2349954 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Did subject withdraw from study as a result of non-serious AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility the non-serious AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Relationship to investigational product(s)
Code List
Is there a reasonable possibility 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])
Seriousness
Code List
Does the AE meet the definition of serious?
CL Item
Yes (Y)
CL Item
No (N)
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