AE rates for a drug are not compared against a control group (eg, placebo) in the real-world setting
Data regarding AEs reported in the real world may be incomplete
There may be unidentified or unaccounted for confounding factors
All of the above
All real-world AEs reported to a sponsor pharmaceutical company must be reported to regulatory agencies (eg, the FDA), regardless of causality
Real-world AEs reported to a sponsor pharmaceutical company only need to be reported to regulatory agencies (eg, the FDA) if there is a suspected causal relationship between the drug and the AE
Regulatory agency (eg, the FDA)
Sponsor pharmaceutical company
All of the above
YES
NO
Characteristics of clinical trial AEs
Characteristics of real-world AEs
AE reporting
Safety signal detection and evaluation
Safety signal communication to the healthcare community
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