ADVERSE EVENT REPORTING Natasha Tomilin, RN BSN DAIT Project Manager

Objectives Define and identify an adverse event (AE) Define and identify a serious adverse event (SAE) Outline the correct documentation of both an AE and SAE Review proper reporting procedures

What is an Adverse Event? Any occurrence or worsening of an undesirable or unintended sign, symptom (including an abnormal laboratory finding), or disease temporally associated with the use of a medicinal product/procedure, whether or not related to the medicinal product/procedure.

Defining an Adverse Event Adverse Events include, but are not limited to the following: Worsening of conditions present at the onset of the study Concurrent Illnesses Drug reactions or interactions between antiretroviral agents, immunosuppressant medications, or other concomitant medications used on the study

Defining an Adverse Event Abnormal lab values Clinically significant abnormalities found upon exam or through tests and procedures Surgical complications of transplant Subjective reports by the participant that meet AE criteria Example: Participant 001 reports having a severe headache that resolved with OTC medication

Defining an Adverse Event If a condition is present at baseline, is clearly documented, and does not change in severity, it is not reported as an AE For this trial, all Grade 2 or higher events are reported as adverse events If the condition resolves or begins to resolve, then worsens again (to a grade 2 or higher), this is considered an AE

Documenting Adverse Events Record the following information in the source documentation: Event Onset date Expected or anticipated Relation to therapy Effect on therapy Outcome/Resolution

Reporting Adverse Events The following tables will be used to grade adverse and serious adverse events: The Division of AIDS Table for Grading Adult Adverse Experiences The Division of AIDS Table for Grading Pediatric Adverse Experiences

Grading Adverse Events For abnormalities not found in the Toxicity Tables, the following scale will be used to estimate grade: Grade 1, Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Grade 2, Moderate: Mild to moderate limitation in activity –some assistance may be needed; no or minimal medical intervention/therapy required

Grading Adverse Events Grade 3, Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required and hospitalization possible Grade 4, Life-Threatening: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required; hospitalization or hospice care probable Any event deemed by the clinician to be serious or life threatening should be considered a Grade 4

Reporting Guidelines Once an AE is recognized, an electronic form should be completed in the IDES All information contained in the form should be supported by source documentation Follow-up information should be submitted once available

What is a Serious Adverse Event? A serious adverse event or reaction is defined as any adverse event that suggests a significant contraindication to ongoing therapy

Serious Adverse Event Serious adverse events typically meet the following criteria: Death Life-threatening Inpatient hospitalization or prolongation of an existing hospitalization Persistent or significant disability/incapacity Congenital anomaly/birth defect An event that requires intervention to prevent permanent impairment or damage

Serious Adverse Event Reporting Within 24 hours of the event, complete a serious adverse event form in the IDES Fax supporting documentation to EMMES: Narrative summary Discharge summary (if applicable) Laboratory tests, consultation and biopsy reports, and/or any other reports Any additional information related to the event All information contained in the form should be supported by source documentation

Serious Adverse Event Reporting Enter follow-up information in the IDES as well as fax follow-up source documentation to EMMES once available Source documents faxed to EMMES should be identified by participant ID number Follow-up information should be provided until the event has resolved EMMES Fax Number: 301-251-1355

Serious Adverse Event Review Both the protocol co-chairs and NIAID co-medical monitors will receive notification of an SAE within 24 hours to determine if any immediate actions must be taken The Operations Committee will review data listings of the adverse and serious adverse events on a monthly basis The Data Safety and Monitoring board will routinely review safety data

Summary Please remember to report adverse and serious adverse events within the appropriate timelines Adverse and serious adverse events should be reported to each individual IRB according to institutional guidelines Subjects should be informed of new findings throughout the trial