Vigabatrin (All indications)

All congenital malformations (majors, minors, majors and minors, or unspecified)

id	Study   Auto Vajda (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2019Vajda (Vigabatrin) (Controls unexposed, sick), 2019Tomson (Vigabatrin), 2018Källén (Vigabatrin) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013Källén (Vigabatrin) (Controls unexposed, NOS) (Indications NOS), 2013Mawer (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2010Mawer (Vigabatrin) (Controls unexposed, disease free), 2010Mawer (Vigabatrin) (Controls unexposed, sick), 2010Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006Morrow (Vigabatrin) (Controls unexposed, sick), 2006	Lib. in paper	Exposition period  Auto during pregnancy (anytime or not specified)1st trimester2nd trimester3rd trimester2nd and/or 3rd trimesterthroughout pregnancyearly pregnancydays before deliverylate pregnancypreconception-onlypericonceptionalpreconceptional for kinetic reasonat least 1st trimester3 months (or more) before pregnancy or during pregnancy1st and 2nd trimester3 months or more before pregnancy or1st trimester	Study type  All studies Case control excluded Only case control	Control type    Auto unexposed (general population or NOS)unexposed, sickunexposed, disease freeexposed to other treatment, sicknot specifiedwhatever (meta-analysis)	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S9803 R35179	Vajda (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2019	Fetal malformations	at least 1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	18.80 [0.36;971.86] C excluded (control group)	0/1   20/406	20	1		ref
S9804 R35180	Vajda (Vigabatrin) (Controls unexposed, sick), 2019	Fetal malformations	at least 1st trimester	prospective cohort	unexposed, sick	Adjustment: No	31.00 [0.56;1711.11] C	0/1   5/176	5	1		ref
S9802 R35085	Tomson (Vigabatrin), 2018	Malformed Offspring	at least 1st trimester	prospective cohort	exposed to other treatment, sick	Adjustment: No	4.68 [0.24;91.38] C	0/4   74/2,514	74	4		ref
S9795 R35065	Källén (Vigabatrin) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013	Relatively severe malformations	early pregnancy	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No	1.86 [0.10;33.18] C excluded (control group)	0/8   37/1,084	37	8		ref
S9796 R35067	Källén (Vigabatrin) (Controls unexposed, NOS) (Indications NOS), 2013	Relatively severe malformations	early pregnancy	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: No	2.06 [0.12;36.00] C	0/8   49,499/1,575,847	49,499	8		ref
S9797 R35069	Mawer (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2010	Major malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	13.80 [0.22;853.65] C excluded (control group)	0/1   2/37	2	1		ref
S9798 R35071	Mawer (Vigabatrin) (Controls unexposed, disease free), 2010	Major malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No Matched	42.85 [0.79;2330.91] C excluded (control group)	0/1   6/285	6	1		ref
S9799 R35073	Mawer (Vigabatrin) (Controls unexposed, sick), 2010	Major malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	26.33 [0.38;1837.92] C	0/1   1/41	1	1		ref
S9800 R35081	Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006	Major congenital malformation	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	2.64 [0.14;49.38] C excluded (control group)	0/6   21/647	21	6		ref
S9801 R35083	Morrow (Vigabatrin) (Controls unexposed, sick), 2006	Major congenital malformation	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	2.34 [0.12;45.78] C	0/6   8/227	8	6		ref
					Total	5 studies	5.04 [1.16;21.81]		49,587	20
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

Sensitivity analysis

Publication bias and p-hacking diagnosis

Sub-groups analysis using all included studies

excluded 9800, 9797, 9798, 9795, 9803