Studies of drug interventions (especially studies done by pharma for submission to various regulatory bodies) often group their outcomes under the headings of Efficacy, Safety, Tolerability and Pharmacokinetics.
- Instead of trying to find a specific term for Safety or Tolerability, just consider them as synonyms for Adverse Events and annotate them as such.
- Do NOT use the term "Safety Finding" or terms for "Drug Tolerance".
Here is how to annotate these concepts:
- When the word "safety" is mentioned, on its own, just annotate with Adverse Events as the classification, with no term chosen, and paste "safety" into the details box.
- When examples of Safety findings are provided, classify them all as Adverse Events and annotate with more specific terms from our vocabulary (if available). If no terms are available, annotate as above.
- Phrases to watch for when the terms are used in this way:
"safety finding"
"Safety as assessed by proportion of neonates with adverse events ..."
"efficacy and safety outcomes"
"safety data"
"safety laboratory parameters"
