Beschreibung

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.

Datentyp

text

Alias

UMLS CUI [1]

C1518404

Beschreibung

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.

Datentyp

text

Alias

UMLS CUI [1,1]

C1518404

UMLS CUI [1,2]

C0011900

UMLS CUI [2,1]

C1518404

UMLS CUI [2,2]

C1457887

Beschreibung

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

Datentyp

date

Alias

UMLS CUI [1]

C2985916

Beschreibung

Amend the intensity if it increases.

Datentyp

text

Alias

UMLS CUI [1,1]

C0877248

UMLS CUI [1,2]

C0518690

Beschreibung

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.

Datentyp

text

Alias

UMLS CUI [1,1]

C1705586

UMLS CUI [1,2]

C1518404

Beschreibung

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".

Datentyp

date

Alias

UMLS CUI [1]

C2985918

Beschreibung

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).

Datentyp

text

Alias

UMLS CUI [1,1]

C1704758

UMLS CUI [1,2]

C1518404

Beschreibung

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

Datentyp

text

Alias

UMLS CUI [1,1]

C1710677

UMLS CUI [1,2]

C1518404

Beschreibung

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.

Datentyp

text

Alias

UMLS CUI [1,1]

C1518404

UMLS CUI [1,2]

C0013230

UMLS CUI [1,3]

C0439849

Beschreibung

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

Datentyp

text

Alias

UMLS CUI [1]

C1710056