Profile of adverse event, using Common Terminology Criteria (CTC).

A determination if the adverse event is or is not one whose nature and severity have been previously observed, identified in nature, severity, or frequency, and documented in the investigator brochure, investigational plan, protocol, current consent form, scientific publication, or in other relevant and reliable document.

Participant can be used to represent the approver of the adverse event

The date (and time) when the adverse event ends or returns to baseline (NCI Thesaurus).

The reason an adverse event is serious

The grade associated with the severity of an adverse event, using CTCAE criteria. The code ‘0’ representing no adverse event may be used to provide positive confirmation that the clinician assessed or considered this particular AE, although the absence of an adverse event is generally not reportable. See https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm

An expected adverse event is one whose nature and severity have been previously observed, identified in nature, severity, or frequency, and documented in the investigator brochure, investigational plan, protocol, current consent form, scientific publication, or in other relevant and reliable document. An unexpected adverse event is one that has not been previously observed, whether or not the event was anticipated because of the pharmacologic properties of the study agent or the nature of the medical procedure. This includes events that are more serious than expected or occur more frequently than expected, particularly, any adverse experience, the nature, severity or frequency of which is not consistent with the product label, or with the current investigator brochure for investigational agent; or with the risk information described in the investigational plan or protocol or consent form (NCI Thesaurus).

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

Codes qualifying the adverse event’s relationship to the medical intervention, according to WHO causality assessment criteria: it is applicable to a clinical event, including laboratory test abnormality, occurs in a plausible time relationship to medical intervention, and cannot be explained by concurrent disease or other interventions.

The outcome of a serious adverse event

An adverse event is classified as serious or non-serious. It is considered serious if it results in any of the following outcomes: (1) Death, (2) Life-threatening experience, 3) Inpatient hospitalization or prolongation of existing hospitalization (for > 24 hours), (4) Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, (5) Congenital anomaly/birth defect, or (6) Important Medical Event (IME) that may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition (reference: https://crawb.crab.org/txwb/CRA_MANUAL/Vol1/chapter%2013_Serious%20Adverse%20Events.pdf).

CTCAE Grades 0 through 5. The grade of the adverse event, determined by CTCAE criteria, where 0 represents confirmation that the given adverse event did NOT occur, and 5 represents death. Note that grade 0 events are generally not reportable, but may be created to give positive confirmation that the clinician assessed or considered a particular AE.

The NCI Common Terminology Criteria for Adverse Events (CTCAE) is utilized for Adverse Event (AE) reporting. The codes are drawn from the NCI Thesaurus. Each CTCAE term is a MedDRA LLT (Lowest Level Term) with corresponding codes that can be used in place of the NCI code. The value set is CTCAE 5.0 and corresponds to MedDRA version 20.1. See https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_5.0/NCIt_CTCAE_5.0.xlsx.

Use of ‘Other, specify’: In the event a suitable CTCAE term cannot be found, the appropriate verbatim term SHALL be captured via the ‘Other, specify’ mechanism. In this case, the verbatim term is populated into the event.text field, the NCIT code for the body system into the event.coding.code field, and the display string corresponding to the code into the event.coding.display field. For example, if reporting the unusual adverse event ‘Vulcan-green blood’ it will be reported as: event.text of ‘Vulcan-green blood’, event.coding.display of ‘Blood and lymphatic system disorders - Other, specify’, and event.coding.code of NCIT code C143323.

Common terminology criteria (CTC) grades associated with the severity of an adverse event, expressed as integers, 0 through 5, with 0 representing no adverse event, and 5 representing death.

Grade 2 dehydration attributed to gefitinib

Non-occurrence of anemia

Grade 3 dehydration attributed to gefitinib

Compass Trial example patient Kaitlyn

Example for Patient

Example for Practitioner

Alliance COMPASS Protocol A011801

Example for Organization

Standard of Care Protocol 0U812

Extended AdverseEvent example as a Patient Bundle for Compass Trial

Extended AdverseEvent example as a Patient Bundle

Extended example: example showing chemotherapy medication

Anemia grade 2

Anemia grade 1

Grade 1 ALT

Grade 3 ALT

ALT back to grade 1 and resolved

Grade 1 Nausea/vomiting

Nausea grade 1

Neutropenia grade 3

Neutropenia grade 0

CBC Diagnostic Report

CBC Diagnostic Report

Encounter identifying adverse events after A-C cycle 1

Primary Cancer Condition for Kaitlyn B

chemotherapy medication administered

Example showing clinial trial medication adminstration Kadcyla

Example showing clinial trial medication adminstration Tucatinib

Example showing clinial trial medication Kadcyla

Example showing clinial trial medication Tucatinib

Extended example: example showing chemotherapy medication

Example RN practitioner

Extended example: example showing primary cancer condition

CBC observation

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Extended example: example organization

Extended example: example organization

Extended example: example RN practitioner

Extended example: example practitioner