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.

Describes the severity 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.

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

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

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

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