疾病等

14:10 Jun 17, 2022

This question was closed without grading. Reason: Answer found elsewhere

Japanese to English translations [PRO]
Medical - Medical: Pharmaceuticals

Japanese term or phrase: 疾病等

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!

Luca Balestra KudoZ activity Questions: 89 (2 open) (1 without valid answers) (2 closed without grading) Answers: 0 United Kingdom
Local time: 15:08

Summary of answers provided

5 +1

disease or the like

Yuka Kinoshita, MD, PhD

Discussion entries: 1

Answers

6 days confidence:

peer agreement (net): +1

disease or the like

Explanation:
It seems "疾病等” is a term used in Clinical Trials Act. You can refer to the attached website. It translates "疾病等" as "disease or the like."

https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000213334.pdf

Yuka Kinoshita, MD, PhD
Japan
Local time: 23:08
Native speaker of:

Japanese

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