Japanese to English Medical Medical: Pharmaceuticals

Hi all, I have come across this term in a clinical trial protocol. The ful sentence is as follows:

「疾病等」とは、本研究の実施に起因すると疑われる疾病、障害若しくは死亡又は感染症であり、意図しない兆候、臨床検査値の異常や諸症状を含む。よって疾病等とは、特定臨床研究との因果関係が否定できない有害事象であり、「有害事象」のうち、研究責任医師又は研究分担医師が本研究との因果関係ありと判断したものは「疾病等」に該当する。

I am not sure I understand this parapgraph, as it seems to simultaneously say that 疾病等 is an event for which a causal relationship to the study cannot be ruled out (but does not necessarily exist), and an event for which a causal relationship has been deemed present by the investigators.

Should I render 疾病等 simply as "adverse reaction", or does it mean "suspected adverse reaction," "confirmed adverse reaction" or both?

Thanks in advance!