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 (sā=ā3)). 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.