Table I.

Angioedema events in propensity score-matched levetiracetam and phenytoin exposed patients using per-protocol analysis and intent-to-treat analysis

		Levetiracetam			Phenytoin
	Source	Patients	Days treated	Events	Patients	Days treated	Events	Hazard ratio (Cl)	p-Value (calibrated)
Per protocol	IMS P-Plus	6,893	351,090	2	7,745	398,827	2	1.41 (0.05–36.73)	0.83 (0.79)
	Optum Clinformatics	10,819	3,150,504	14	14,115	3,030,739	19	0.69 (0.18–2.34)	0.57 (0.62)
	Truven CCAE	13,088	3,549,812	13	16,234	2,962,530	14	0.59 (0.15–1.93)	0.41 (0.45)
	Truven MDCD	8,227	1,883,518	15	9,969	1,666,857	19	0.65 (0.20–1.91)	0.45 (0.55)
	Truven MDCR	4,592	1,400,797	8	6,433	1,564,355	14	0.96 (0.28–3.1 1)	0.94 (0.94)
	IMS Ambulatory	8,762	618,757	1	10,732	730,158	3	0.00 (0.00–1.41)	0.23 (0.23)
	Cerner Health Facts (UT)	5,584	54,852	1	7,624	93,543	0	–	–
	Columbia	501	111,307	0	603	68,251	0	–	–
	IMS French EMR	7	552	0	37	2,463	0	–	–
	Stanford EMR	404	12,313	0	460	13,525	0	–	–
lntent-to-treat	IMS P-Plus	18,213	16,233,093	78	21,631	18,398,218	117	0.61 (0.42–0.87)	0.01 (0.008)
	Optum Clinformatics	10,890	9,101,161	31	14,254	10,818,306	65	0.73 (0.39–1.33)	0.31 (0.36)
	Truven CCAE	13,434	11,347,801	41	16,886	13,390,9 IS	61	0.87 (0.49–1.52)	0.63 (0.57)
	Truven MDCD	8,536	7,328,658	41	11,688	9,603,677	96	0.43 (0.25–0.72)	0.00 (0.002)
	Truven MDCR	4,656	4,317,982	15	6,534	5,516,323	37	0.54 (0.23–1.18)	0.14 (0.19)
	IMS Ambulatory	8,762	9,978,497	19	10,732	12,739,915	28	0.65 (0.31–1.31)	0.25 (0.25)
	Cerner Health Facts (UT)	9,094	5,842,344	22	12,076	8,229,377	29	0.95 (0.46–1.94)	0.90 (0.69)
	Columbia	553	523,215	1	686	643,655	1	–	–
	IMS French EMR	7	5,542	0	37	45,559	0	–	–
	Stanford EMR	404	342,136	0	460	41 1,371	0	–	–