Table 2.

Background of drugs and characteristics of EACTs

	Items	Number of trials	%
Therapeutic indication classification	Oncology drugs	23	74.2
	Peripheral nervous system	2	6.5
	Biological product	2	6.5
	Infectious diseases	1	3.2
	Blood derivatives	1	3.2
	Metabolic disease	1	3.2
	Alkylating agent	1	3.2
Disease classification	II Neoplasms	24	77.4
	III Diseases of the blood and certain disorders involving the immune mechanism	1	3.2
	IV Endocrine, nutritional, and metabolic diseases	4	12.9
	VI Diseases of the nervous system	1	3.2
	Unknown	1	3.2
Age, years	≥18	15	48.4
	12–18 years	3	9.7
	2–12 years	1	3.2
	0–2 years	1	3.2
	Unknown	11	35.5
Sponsor	Japanese domestic company	16	51.6
	Global company	14	45.2
	Investigator‐initiated	1	3.2
High degree of social and patient demands	Expanded access program in the United States	5	16.1
	Sakigake designation	2	6.5
	Orphan drug designation	16	51.6
	Drugs for development request by MHLW	0	0.0

EACTs, Expanded Access Clinical Trials; MHLW, Ministry of Health, Labour, and Welfare.