Table 3.

Sensitivity and Secondary Analyses of the Relative Risk of Cardiac Malformations Associated with Exposure to Lithium during the First Trimester.^*

Analysis	Reference†			Exposure to Lithium			Propensity-Score Adjusted Risk Ratio (95% CI)
	No. of Pregnancies	No. of Events	Prevalence per 100 Births	No. of Pregnancies	No. of Events	Prevalence per 100 Births
Main propensity-score-adjusted analysis	1,322,955	15,251	1.15	663	16	2.41	1.65 (1.02–2.68)
Exposure defined by 2 filled prescriptions	1,322,955	15,251	1.15	177	<11‡	2.82	1.61 (0.68–3.83)
Outcome based on infant records only	1,322,955	13,053	0.99	663	16	2.41	1.82 (1.12–2.95)
1-yr Follow-up§	1,095,112	16,648	1.52	550	15	2.73	1.43 (0.87–2.36)
≥1 Diagnosis of bipolar disorder¶	9,485	145	1.53	436	12	2.75	1.70 (0.95–3.03)
≥1 Diagnosis of bipolar disorder, with reference as exposure to lamotrigine¶	798	13	1.63	436	12	2.75	2.62 (1.12–6.10)
Specific cardiac malformations
RVOTO defect	1,322,955	2,447	0.18	663	<11‡	0.60	2.66 (1.00–7.06)
Non-RVOTO defect	1,322,955	12,804	0.97	663	12	1.81	1.46 (0.84–2.57)

^*RVOTO denotes right ventricular outflow tract obstruction.

^†The reference was no exposure to lithium or lamotrigine, unless otherwise specified.

^‡In accordance with the data-use agreement, we do not report information for frequency cells with less than 11 cases.

^§The analysis was restricted to infants continuously eligible for at least 1 year.

^¶The analysis was restricted to women with at least one baseline diagnosis of bipolar disorder.