Computational and Mathematical Methods in Medicine

Research Article

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

Table 5

Analysis of Lipiodol data from multiple studies (integrated results over studies).


Analysis	# signals	AE term (obsstat)	95% threshold

Simple pooled analysis	4	FEVER (473.6)	3.93
		ABDOMINAL PAIN (195.2)
		ANOREXIA/LOSS OF APPETITE (61.0)
		VOMITTING (10.7)
wLRn	4	FEVER (89.7), ABDOMINAL PAIN (66.8)	1.56
		ANOREXIA/LOSS OF APPETITE (44.0)
		VOMITTING (5.9)
MMLR		FEVER (192.9), ABDOMINAL PAIN (171.8)	6.40
		ANOREXIA/LOSS OF APPETITE (130.4)
		HEMATOLOGICAL/BONE MARROW TOXICITY (34.1)
		SHOULDER PAIN (32.2)
		POST EMBOLIZATION SYNDROME (29.6)
		PAIN NOS(30.0), VOMITTING (26.8)
		PLUERAL EFFUSION (18.2), NAUSEA (8.5)

Note. 21 AE-study combination signals detected by MMLR method, p value is 0 for the most significant one (for AE FEVER and 3rd study (s = 3)). 10 AE terms were reported in those signals ignoring the study information and are shown in the column for AE term with maximum observed logLR over the studies.