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Definitions

Adverse Event Any untoward medical occurrence in a patient or clinical investigation subject

administered a pharmaceutical product and which does not necessarily have a

causal relationship with this treatment. An adverse event (AE) can therefore be

any unfavourable and unintended sign (including an abnormal laboratory

finding), symptom, or disease temporally associated with the use of a medicinal

(investigational) product, whether or not related to the medicinal

(investigational) product.

Unexpected

adverse event

an event when the specificity or severity is not consistent with the investigator

brochure or general investigative plan

Related adverse

event adverse event

when there is a reasonable possibility that the adverse event is caused by the

research activity (drug/device/procedure)

Definitely Related

adverse event

An adverse event that has a timely relationship to the administration of the

investigational drug/study procedure and follows a known pattern of response

for which no alternative cause is present.

Probably related

adverse event

AE has a timely relationship to the administration of the investigational

drug/study procedure and follows a known pattern of response, but for which a

potential alternative cause may be present.

Possibly related

adverse event

AE has a timely relationship to the administration of the investigational

drug/study procedure, follows no known pattern of response, but a potential

alternative cause does not exist

Unrelated

adverse event

There is evidence that the AE is definitely related to a cause other than the

investigational drug/study procedure; in general, no timely relationship to the

administration of the drug/procedure exists, or if so, the event does not follow a

pattern of response and an alternative cause is present.

Adverse Drug

reactions

All noxious and unintended responses to a medicinal product related to any

dose should be considered.

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Mild adverse

events

Awareness of signs or symptoms, but easily tolerated; are of minor irritant

type; causing no loss of time from normal activities; symptoms would not

require medication or a medical evaluation; signs and symptoms are transient.

Moderate

adverse events

Discomfort severe enough to cause interference with usual activities; persistent

or requiring treatment.

Severe adverse

event

The term "severe" is often used to describe the intensity (severity) of a specific

event (as in mild, moderate, or severe); the event itself, however, may be of

relatively minor medical significance.

Clinical Study Bioavailability/Bioequivalence study or Phase 1 study

Serious adverse

event (SAE):

Any untoward medical occurrence in a patient or clinical investigation in a

subject administered a pharmaceutical product with any dose that:

Results in death, is life-threatening, requires in-patient hospitalization or

prolongation of existing hospitalization, results in persistent or significant

disability/ incapacity, or is a congenital anomaly/birth defect.  Important

medical events that may not result in death, be life-threatening, or require

hospitalization may be considered a serious adverse experience when, based

upon appropriate medical judgment, they may jeopardize the patient or subject

and may require medical or surgical intervention to prevent one of the

outcomes listed above.

E2A:Clinical safety data management; definitions and standards for expedited data reportingE2B: ICH; Guidance on data elements for transmission of individual case safety reportsE2C: Clinical safety data management; periodic safety update reports for marketed drugsSchedule Y: Requirements and guidelines for permission to import and/or manufacture new

drugs for sale or to undertake clinical trialsICH Harmonised tripartite guideline for Good Clinical Practice E6 recommended for adoption atstep 4 of the ICH process on 01 may 1996 by the ICH Steering Committee (including the poststep 4 corrections agreed by this Steering Committee on 10 June 1996).