SERIOUS ADVERSE EVENT REPORTING - SWOG

REPORTING GUIDELINES (trials approvedProtocol Section 16Grade 2 - Unexpected, atleast possibly relatedGrade 3 – If hospitalization(all) and withouthospitalization(unexpected and at leastpossibly related)Grade 4 and 5 - All(trials approved before 3/28/11)SAE REPORTINGTHE BASICS: New trials approved after 3/28/111. Determine whether there is an AdverseEvent?2. Grade?3. Attribution?4. Expected or Unexpected?5. Investigational or Commercial agent?6. Require or prolong Hospitalization?REPORTING GUIDELINES (trials approvedInvestigational Phase 2 or 3(within 30 days of last dose of drug)(trials approved after 3/28/11)HospitalizationGrade 1 - 5Without hospitalizationGrade 3 - 5Page

SAE REPORTING GUIDELINESHospitalization?An inpatient stay greater than or equal to 24hoursDoes not include: hospitalization forobservation or minor treatment and released grade listedIf more than oneinvestigational agent,use lowest grade todetermine reporting(trials approved after 03/28/11)Page

NEW SAE REPORTING GUIDELINESSpecific ProtocolExceptions toExpedited Reportingfor SWOG-held INDs(trials approved after 03/28/11)NEW SAE REPORTING GUIDELINES(trials approved after 03/28/11)Investigational Late Phase 2 or 3 Studies(within 30 days of last dose of drug)Hospitalization Grade 1 Grade 2 Grade 3 Grade 4 & 5WithHospitalization> 24 hoursWithoutHospitalization10 Calendar DaysNot Required10 CalendarDays24- Hour;5 CalendarDayNEW SAE REPORTING GUIDELINES(trials approved after 03/28/11)Investigational Phase 1 or Early Phase 2 Studies(within 30 days of last dose of drug)Hospitalization Grade 1 & Grade 2 Grade 3, 4 & 5WithHospitalization> 24 hoursWithoutHospitalization10 Calendar DaysNot Required24 hour,5 Calendar DaysPage

SAE REPORTINGBaseline AEs or recurrent AEsA pre-existing condition from baseline is onlyreported if the grade increases or results inhospitalization and/or prolongation ofhospitalizationA recurrent AE that resolves and then recursdoes not require reporting unless the gradeincreases or hospitalization is associated withthe recurring AESAE REPORTINGADVERSE EVENTS >30 DAYS AFTERINVESTIGATIONAL DRUG TREATMENTPhase 1 and Early Phase 2 Studies:All Grade 3 - 5 AEs require expedited 24-hour notificationfollowed by complete report within 5 calendar daysLate Phase 2 and Phase 3 Studies:All Grade 4 - 5 AEs require expedited 24-hour notificationfollowed by complete report within 5 calendar days. Grade 2AEs resulting in hospitalization or prolongation ofhospitalization and Grade 3 AEs require expedited 10 calendarday reportsSECONDARY MALIGNANCYA secondary malignancy is a cancer causedby treatment for a previous malignancyAll secondary malignancies (AML, ALL, MDS)that occur following treatment with anagent under an NCI IND must be reportedA second malignancy (one unrelated to thetreatment of a prior malignancy) ormetastasis from the initial malignancy arenot reported as an SAEPage

SAE REPORTINGAll current active studies use CTCAE Version 4.0for SAE reporting although some studies willcontinue to use Version 3.0 for routine adverseevent reporting. Version 4.0 is a majorreorganization of adverse event taxonomy, done toconform to the international standard, MedicalDictionary for Regulatory Activities (MedDRA).Some changes and additions to CTCAE 4.0 affectreporting requirements.SAE REPORTINGThe following guidance for SWOG studies will befollowed:“Surgical and medical procedures” should be notbe reported as SAEs or adverse events unlessexplicitly so directed in the protocol.“Surgical and medical procedures,” “falls,” and“infusion site extravasation” should not be reportedas SAEs unless clearly associated with otherreportable SAEs.SAE REPORTINGReportable categories of death:Death attributable to a CTCAE termDeath NOS: If it cannot be attributed to a CTCAEterm associated with Grade 5Death due to progressive disease should bereported as Grade 5 “Neoplasms benign, malignantand unspecified (incl cysts and polyps) – Other(progressive disease)Page

SAE REPORTING GUIDELINESCOMMERCIAL AGENTS ONLYCURRENTGRADE 4 - Unexpected and possibly, probably ordefinitely relatedGRADE 5NEW GUIDELINES – Exception:Exception: Deaths clearlydue to progressive disease require routine reportingonlySWOG SAE REPORTINGSUPPORTING DOCUMENTATON TOBE SUBMITTED TO OPERATIONSOFFICE WITHIN 5 DAYS• IF SWOG-HELD IND• ALL GRADE 5 UNLESSPROGRESSIVE DISEASE ORCLEARLY UNRELATED (e.g. caraccident)SAE REPORTINGAdEERS REPORTS AREEVALUATED BY:1) SAE COORDINATOR2) MEDICAL REVIEWER3) STUDY COORDINATOR orGROUP CHAIR (PRN)Page

SAE EvaluationDocumentsOperations OfficeReview of SAESWOG SAE REPORTING SUMMARY1) Consider the possibility that any AE could bereportable as an SAE (see Protocol Section 16).2) If indicated, initiate an AdEERS REPORT within24 HOURS of the event or discovery of the event.(if unable to access the internet, contact theOperations office)3) Submit the report within the PROTOCOL-SPECIFICNUMBER OF CALENDAR DAYS4) Send SUPPORTING DOCUMENTATION to theOperations office (as required / requested)CTSU SAE REPORTINGAll Cooperative Groups must follow thesame reporting guidelinesOther groups may have group or protocol-specific requirements so consult theprotocolAny communication should be with the leadgroupPage

SWOG SAE REPORTINGSWOG SAE REPORTING SUMMARYWhen in doubt about whether event is reportable,call or email (adr@swog.org(adr@swog.org) ) the OperationsOffice210-614-8808SAE REPORTINGTHANKS!!Page