1. ADVERSE EVENT REPORTING
Natasha Tomilin, RN BSN
DAIT Project Manager

2. 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

3. 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.

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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:

16. 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

17. 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