Table 4.

Serious ADR of irinotecan, TS-1, and gefitinib reported from clinical trials before approval

	Serious ADR	n	No. cases	Frequency (%)	95% CI
Irinotecan54	Diarrhea	414	71	17.1	13.6-21.1
	Leukopenia	414	134	32.4	27.9-37.1
TS-155	Leukopenia	578	16	2.8	1.6-4.5
	Neutropenia	578	49	8.5	6.3-11.1
	Thrombocytopenia	578	9	1.6	0.7-2.9
Gefitinib12	Interstitial pneumonia	133	3	2.3	0.5-6.5