Table 1.

Signal detection for CDDP-associated mild, severe and lethal hypersensitivity reactions

	Mild	Severe	Lethal
	43,288	18,225	2,397
No.of AERs	38	29	5
PRR (kai2)	0.436 (27.256)	0.790 (1.412)	1.036 (0.022)
ROR (95% two-sided CI)	0.435 (0.317, 0.553)	0.790 (0.549, 1.031)	1.036 (0.431, 1.641)
IC (95% two-sided CI)	-1.195 (-1.651, -0.739)	-0.353 (-0.875, 0.169)	-0.081 (-1.287, 1.125)
EBGM (95% one-sided CI)	0.441 (0.337)	0.781 (0.574)	0.907 (0.455)

Total number of adverse event reports (AERs) accompanied with CDDP administration was 44,321. Reports of mild, severe and lethal hypersensitivity reactions numbered 43,288, 18,225 and 2,397, respectively. PRR: the proportional reporting ratio ³³, ROR: the reporting odds ratio ³⁴, IC: the information component ³⁵, EBGM: the empirical Bayes geometric mean ³⁶. There was no signal for CDDP-associated mild, severe and lethal hypersensitivity reactions (see “Methods” for the criteria of detection).