sdtm - adverse events vs. clinical events
TRANSCRIPT
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.