Convenience backport into R4 of FHIR R5 Foundational profile of AdverseEvent for Clinical Research communications.

For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.

The date the adverse event was resolved.

Indicates if the subject discontinued the study due to the adverse event.

The contributing factors suspected to have increased the probability or severity of the adverse event.

Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.

Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.

Comments made about the adverse event by the performer, subject or other participants.

Indicates who or what participated in the adverse event and how they were involved.

Communicates Research Subject related metadata.

Information about the condition that occurred as a result of the adverse event.

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject’s medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.

Describes the entity that is suspected to have caused the adverse event.

The current workflow state of the adverse event or potential adverse event. This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient’s condition.

This value set includes codes that describe the type of involvement of the actor in the adverse event.

Codes identifying the lifecycle stage of an adverse event.

This value set includes codes that describe the contributing factors suspected to have increased the probability or severity of the adverse event.

This value set includes codes that describe the ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.

This value set includes codes that describe the ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.

This value set includes codes that describe the supporting information relevant to the event.

This value set includes codes that describe the adverse event or incident that occurred or was averted.

Adverse event from procedure, not study drug

example

Non-Serious Adverse Event Research Study Medication Example

Patient report of Adverse Event, example of data that would be on MedWatch form as reported by Patient

Serious Adverse Event Research Study Medication Example

Grade 1 ALT

Grade 3 ALT

ALT back to grade 1 and resolved

Grade 1 Nausea/vomiting // both are AEs, which to use or make them separate?

Device suspected entity

Headache

The fifth subject enrolled in the trial develops severe hepatic failure complicated by encephalopathy one month after starting the study. The study sponsors determined that is an unanticipated problem that must be reported because although the risk of mild liver injury was foreseen, severe liver injury resulting in hepatic failure was unexpected in severity; possibly related to participation in the research; and serious.

The fifth subject enrolled in the trial develops severe hepatic failure complicated by encephalopathy one month after starting the study. The study sponsors determined that is an unanticipated problem that must be reported because although the risk of mild liver injury was foreseen, severe liver injury resulting in hepatic failure was unexpected in severity; possibly related to participation in the research; and serious.

Moderate hives

Breast Cancer clinical trial example

Clinical Trial subject number 5. Acute Hepatic Failure.

Device - Infuser that exploded

Patient enrolled in ACME study, taking Study Medication WBY 10 mg orally daily every morning for moderate asthma

Gastrointestinal (GI) bleed

Janet Blood Pressure Observation

Patient Janet, 64-year old woman on clinical trial

Self reported Janet Tylenol PM med

Self reported Janet allergy med

Self reported Janet pill for water retention med not known

Janet weight observation

Study medication info Medication Administration for bresentrik

Medication administration example

Study medication info Medication Request for bresentrik

Study medication info Medication Request for clinical trial medication 0301 - discontinued

Study medication info Medication Request for clinical trial medication ABC - discontinued

Study medication, bresentrik

Patient MOUMIC on Research Study DISNEY

Patient reported AE problem

SAE Patient SCHJO on Research Study XYZ, Study ID XYZ-123, Subject number XYZ-123-002.

Clinical trial ACME protocol-prescribed procedure of a Lung CT Scan, with contrast dye

Clinical trial ACME research subject

Alliance COMPASS Protocol A011801

Alliance COMPASS trial research subject

Alliance COMPASS trial research subject

Example medication administration for contrast dye

Example medication administration for hives

Example showing clinical trial medication administration Kadcyla

Example reduced dose of clinical trial medication administration Kadcyla

Example showing clinical trial medication administration Kadcyla

Example showing clinical trial medication administration Tucatinib

Example reduced does of clinical trial medication administration Tucatinib

Example of Tylenol

Example contrast dye medication

Example medication for hives

Example showing clinical trial medication Kadcyla

Example showing clinical trial medication Kadcyla

Example showing clinical trial medication Tucatinib

Example for medication Zofran

Example medication for Tylenol

Compass Trial example patient Kaitlyn

Compass Trial example patient Kaitlynn B1

Example RN practitioner

Example Oncologist

Example Procedure Upper Endoscopy

Research Study DISNEY

Research Study XYZ

Use Case 17 Research Study ACME

Example clinical trial medication WBY

Example study medication ABC

Example study medication MMD

Example for clinical trial medication ABC

Example for clinical trial medication MMD

Example for clinical trial medication WBY