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

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

adverse event

brochure or general investigative plan

Related adverse

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

event adverse event

research activity (drug/device/procedure)

Definitely Related

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

adverse event

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

for which no alternative cause is present.

Probably related

AE has a timely relationship to the administration of the investigational

adverse event

drug/study procedure and follows a known pattern of response, but for which a
potential alternative cause may be present.

Possibly related

AE has a timely relationship to the administration of the investigational

adverse event

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

alternative cause does not exist

Unrelated

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

adverse event

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

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

reactions

dose should be considered.

Mild adverse

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

events

type; causing no loss of time from normal activities; symptoms would not
require medication or a medical evaluation; signs and symptoms are transient.

Moderate

Discomfort severe enough to cause interference with usual activities; persistent

adverse events

or requiring treatment.

Severe adverse

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

event

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

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

Serious adverse
event (SAE):

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 reporting
E2B: ICH; Guidance on data elements for transmission of individual case safety reports
E2C: Clinical safety data management; periodic safety update reports for marketed drugs
Schedule Y: Requirements and guidelines for permission to import and/or manufacture new
drugs for sale or to undertake clinical trials
ICH Harmonised tripartite guideline for Good Clinical Practice E6 recommended for adoption at
step 4 of the ICH process on 01 may 1996 by the ICH Steering Committee (including the post
step 4 corrections agreed by this Steering Committee on 10 June 1996).