Likelihood-Ratio-Test Methods for Drug Safety Signal Detection from Multiple Clinical Datasets

Table 4

Analysis of Lipiodol data (individual study analysis). Bold AE terms are in the PES group.

Studies	# signals	AE terms	obsstat	value	95% threshold
s = 1	0	None			3.33
s = 2	4	ABDOMINAL PAIN	171.8	0	3.93
		FEVER	157.5	0
		ANOREXIA/LOSS OF APPETITE	130.4	0
		VOMITTING	11.6	0
s = 3	3	FEVER	192.9	0	4.50
		ABDOMINAL PAIN	56.7	0
		NAUSEA	8.5	0
s = 4	2	FEVER	7.8	0	4.77
		ABDOMINAL PAIN	4.8	0.003
s = 5	3	FEVER	29.4	0	4.72
		ABDOMINAL PAIN	6.7	0
		NAUSEA	4.73	0.007
s = 6	1	POST EMBOLIZATION SYNDROME	29.6	0	3.73
s = 7	1	SHOULDER PAIN	32.2	0	4.89
s = 8	2	VOMITTING	23.6	0	4.89
		ABDOMINAL PAIN	7.3	0
s = 9	4	HEMATOLOGICAL or BONE MARROW TOXICITY	34.1	0	4.02
		FEVER	9.3	0
		BILIRUBIN RELATED ABNORMALITIES	4.7	0.015
		HEPATIC PEDICULITIS	4.7	0.015
s = 10	3	PAIN NOS	26.8	0	3.47
		FEVER	24.1	0
		VOMITTING	16.7	0
s = 11	2	FEVER	121.8	0	3.73
		PLUERAL EFFUSION	15.5	0
s = 12	1	FEVER	4.5	0.008	4.38
s = 13	1	RESPPIRATORY DISTURBANCE	3.3	0	3.18