Dictionary

The Dictionary provides concise definitions of health economics terms, arranged alphabetically for quick reference. Use it to understand unfamiliar terminology or confirm the meaning of a specific term.

17 terms matching Adverse Event

A

Adverse Event
An injury caused by medical management, rather than a patient's underlying disease, resulting in prolonged hospitalisation, disability, or death.
Adverse Event Cost
The expense of managing a treatment's side effects, covering additional medical visits, hospitalisation, and supportive medications required.
Adverse Event Rate
A measure of how frequently patients experience unintended harm from medical care, rather than their underlying condition, within a defined population.
Adverse Event Reporting
The systematic process of documenting and communicating instances of patient harm from medical care, used to identify patterns and target improvement.

C

Clinical Trial Data
Data collected within a clinical trial's structured framework, including detailed outcome, adverse event, and often resource use measurements, under controlled conditions.
Common Terminology Criteria
A standardised grading system classifying the severity of adverse events observed in trials, widely used across oncology and other areas.

D

Dose-Limiting Toxicity
A sufficiently severe adverse event in early-phase trials that prevents further dose escalation, used to help determine the maximum tolerated dose.
Dropout
The premature discontinuation of a study participant's involvement before planned completion, whether from withdrawn consent, adverse events, or lost contact.

G

Global Trigger Tool
A structured methodology retrospectively reviewing records for indicators suggesting a possible adverse event, more comprehensively estimating true harm rates than voluntary reporting.

P

PRO-CTCAE
A patient-reported system complementing the clinician-reported Common Terminology Criteria for Adverse Events, letting patients report symptom frequency, severity, and interference directly.

R

Root Cause Analysis
A systematic process investigating a serious adverse event to identify its fundamental, underlying causes, rather than only surface-level circumstances.

S

Safety
The degree to which an intervention avoids causing unintended harm, assessed through systematic monitoring and reporting of adverse events.
Safety Population
The complete set of trial participants who received at least one dose of study treatment, used to assess adverse events regardless of original assignment.
Serious Adverse Event
An untoward medical occurrence during research or treatment resulting in death, life-threatening risk, hospitalisation, or persistent significant disability, per international guidance.

T

Treatment-Emergent Adverse Event
An adverse event occurring or worsening during a trial period following study treatment administration, regardless of whether causally related.

U

Utility Structure
The way a decision-analytic model assigns health state utility values, including adjustments for factors such as age or treatment-related adverse events.

W

Withdrawal
The voluntary or involuntary discontinuation of a participant's trial involvement before its planned completion, whether from adverse events or personal choice.