Adverse Events

vs

Clinical Events

ByVijayaraghava K.

Synopsis

Introduction Adverse Events Clinical Events Events class variables Case-Study Queries

Introduction Events Class:

Captures planned protocol milestones such as randomization and study completion,

Captures occurrences, conditions, or incidents independent of planned study evaluations (e.g., Medical conditions like adverse events, Medical History, Healthcare Encounters)

Adverse Events: Adverse events that actually occur, captured either as

free text or a pre-specified list of terms Clinical Events:

Captures clinical events of interest that would not be classified as adverse events

Adverse Events

"any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment" - (ICH E2A)

» Both Spontaneous and pre-specified AEs can be included in this data set

» Records for only those events, which occurred should be included in AE

Clinical Event

– The data may be data about episodes of symptoms of the disease under study (often known as signs and symptoms), or about events that do not constitute adverse events in themselves, though they might lead to the identification of an adverse event

e.g.

Occurrence of migraine headaches in a study of an investigational treatment for migraine

Occurrences of transient ischemic attack (TIA), stroke and death in a study investigational treatment for Ischemic Stroke.

Partial List of Events class variablesAE vs. CE

Case-Study

SYMPTOMS OF INFUSION RELATED REACTIONS

In many Rheumatoid Arthritis studies the study drug is administered by infusion, consequently a choice has been made to group a number of adverse events into a single event - an Infusion Related Reaction

These are collected from a pre-specified list as the individual symptoms associated with the infusion related reaction

Infusion related reactions

Include hypersensitivity reactions and cytokine release syndromes

These reactions are experienced by patients during the infusion of cytotoxic or monoclonal antibody therapy and/or within hours of an infusion (delayed reaction)

Symptoms can include: flushing, alterations in heart rate and blood pressure, dyspnea, bronchospasm, back pain, fever, urticaria, oedema, nausea and all types of rashes

Mapping Options

A potential mapping would be to treat each as an AE and use AEGRPID to group all symptoms and the master AE record together

Could be confusing for a reviewer Non-occurrence of a symptom cannot be mapped Only limited information is collected about symptoms Symptoms and AEs would always be analyzed separately

While this is a valid mapping it was not considered appropriate for this data

Any Queries ???

References

SDTM Ig v.3.2 How Do I Map That? - SDTM Implementation

Challenges - Chris Price, Roche Products Ltd.