Important Medical Event definition

Important Medical Event means an Adverse Event that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or require medical or surgical intervention to prevent one of the outcomes listed in (a)—(e) of the definition of Serious Adverse Event. Examples of such events include invasive or malignant cancers, intensive treatment (in an emergency room or at home) for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or the development of drug dependency or abuse, overdose or misuse.

Examples of Important Medical Event in a sentence

• An employee shall not be entitled to takein advanceCommented [ML34]: Housekeeping Changevacation unless the date(s) of the vacation are approved by theemployee's Department Head, or, in the event of the Department Head's refusal or failure to do so, by the City Manager.

• This does not include an emergency room visit or admission to an outpatient facility.Congenital Anomaly An anomaly detected at or after birth, or any anomaly that results in fetal loss.Persistent or Significant Disability/Incapacity Important Medical Event Requiring Medical or Surgical Intervention to Prevent Serious OutcomeAn event that results in a condition that substantially interferes with the activities of daily living of a study subject.

• Furthermore, all fetal loss pregnancy outcomes (ectopic pregnancy, elective termination, spontaneous abortion, late fet al death) must be reported as aV503-004-02 15-Mar-2017Serious Adverse Experience (Other Important Medical Event).

• Important Medical Event or Medical InterventionMedical and scientific judgment should be exercised in deciding whether a case is serious in situations where important medical events may not be immediately life threatening or result in death, hospitalization, disability or incapacity but may jeopardize the subject or may require medical intervention to prevent one or more outcomes listed in the definition of serious.

• Any medical event that the investigator considers to be "medically important" in the context of pediatric drug exposure (for example neurodevelopmental delay), may be reported as an SAE under the category "Important Medical Event." (see Section 7.1.1) Serious adverse events, whether related or unrelated to study drug, must be recorded on the SAE page of the CRF and reported within 24 hours to BMS (or designee) to comply with regulatory requirements.

• Furthermore, all fetal loss pregnancy outcomes (ectopic pregnancy, elective termination, spontaneous abortion, late fetal death) must be reported as a Serious Adverse Experience (Other Important Medical Event).

• At the discretion of the IT System Administrator and departmental leadership, the lifecycle may be extended for implementation of the policy.

• Summaries and listings of SAEs and Serious TEAEs include SAEs upgraded by the sponsor based on review of the Sponsor’s list of Always Serious terms or upgraded according to the Important Medical Event process, if any upgrade was done.The coding dictionary for this study will be MedDRA.

• The investigators will be notified of any AE that is entered in the eCRF that meets criteria as an Important Medical Event per Always Serious List.

• A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that:• Results In Death• Is Life-Threatening (Immediate Risk Of Death)• Requires Inpatient Hospitalization or Prolongation of Existing Hospitalization• Results In Persistent Or Significant Disability/Incapacity• Results In Congenital Anomaly/Birth Defect• Important Medical Event Medical and scientific judgment should be exercised in determining whether an event is an important medical event.