The sentence is trying to differentiate between adverse drug reactions (ADRs) and adverse events (AEs). Adverse events are medical symptoms or events that might not have a link to the study drug, but occur during the clinical study.

This site explains the difference: http://www.innovativescience.net/blog/bid/103583/How-to-Dist...

It also quotes a textbook to say: "The principal difference between an adverse event and an adverse drug reaction is that a causal relationship is suspected for the latter, but is not required for the former. In this framework, adverse drug reactions are a subset of adverse event reports."

В сводную таблицу были включены нежелательные лекарственные реакции (ADRs) и нежелательные явления, не обусловленные действием лекарственного препарата (non-suspected AEs)


AEs = non-suspected AEs + SARs (SADRs) + ARs (ADRs)



AE (Adverse Event) = Any untoward medical occurrence associated with the use of a drug, whether or not considered drug related
Non-suspected AE = Adverse Event not considered drug related
Suspected AR/ADR (Suspected Adverse Reaction/Adverse Drug Reaction) = Any Adverse Event suspected drug related
AR/ADR = Any Adverse Event considered drug related, caused by a drug

https://www.fda.gov/downloads/drugs/scienceresearch/research...