Table 2.

Characteristics of the subjects

		Safety analysis population
Patient factor		Patients (N)	Proportion (%)
Total		624	100.0
Reason for use	HIV infection	624	100.0
Sex	Male	579	92.8
	Female	45	7.2
Age†	15–64 years	599	96.0
	65–81 years	23	3.7
Ethnic groups	Japanese	589	94.4
	Others	35	5.6
History of treatment with antiretrovirals	Absent	213	34.1
	Present	411	65.9
History of allergy	Absent	322	51.6
	Present	210	33.7
	Unknown	92	14.7
Complications	Absent	158	25.3
	Present	466	74.7
Renal impairment	Absent	586	93.9
	Present	38	6.1
Hepatic disorder	Absent	461	73.9
	Present	163	26.1
Haemophilia	Absent	584	93.6
	Present	40	6.4
Concomitant use of non anti-HIV drugs	Absent	0	0.0
	Present	624	100.0
Number of concomitant anti-HIV drugs‡	None	0	0.0
	1 drug	284	45.5
	2 drugs	263	42.1
	3 drugs	62	9.9
	≥4 drugs	15	2.4
CDC classification	A	240	38.5
	B	34	5.4
	C	121	19.4
	Unknown	228	36.5
Total duration of treatment (days)	2–180	623	99.8
	181–365	529	84.8
	366–730	444	71.2
	731–1517	234	37.5

^†Two pts were <15 years old.

^‡Total numbers throughout the observed periods.