Carbamazepine (All indications)

Major congenital malformations

R analysis

id	Study	Lib. in paper	Exposition period	Study type All studies Case control excluded Only case control	Control type	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S15367 R63239	Bromley (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023	Major congenital anomaly	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	2.75 [0.44;17.33] ^C excluded (control group)	2/27 3/106	5	27		ref
S15368 R63252	Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023	Major congenital anomaly	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	2.05 [0.32;13.00] ^C excluded (exposition period)	2/27 3/80	5	27		ref
S15199 R62341	Cohen (Carbamazepine) (Mixed indications) (Controls exposed to LTG), 2023	Major congenital malformations (excluding genetic/chromosomal)	1st trimester	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: Yes Partial overlapping	0.91 [0.72;1.15] excluded (control group)	90/2,674 314/8,339	404	2,674		ref
S15198 R62334	Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023	Major congenital malformations (excluding genetic/chromosomal)	1st trimester	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: No Partial overlapping	1.11 [0.90;1.37] ^C	90/2,674 147,928/4,866,362	148,018	2,674		ref
S15852 R65260	Li (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023	Major congenital malformation	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	9.55 [0.47;192.46] ^C excluded (control group)	3/31 0/38	3	31		ref
S15267 R62752	Li (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023	Major congenital malformation	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	3.77 [0.92;15.39] ^C excluded (exposition period)	3/31 7/253	10	31		ref
S12674 R47886	Mari (Carbamazepine), 2022	Major foetal malformation	throughout pregnancy	retrospective cohort	exposed to other treatment, sick	Adjustment: No	1.15 [0.04;30.40] ^C	1/29 0/11	1	29		ref
S10225 R37454	The NAAED (Controls exposed to Lamotrigine, sick) (Indications NOS), 2022	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	1.48 [0.93;2.35] ^C excluded (control group)	31/1,122 44/2,333	75	1,122		ref
S10226 R37460	The NAAED (Controls unexposed, disease free) (Indications NOS), 2022	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free	Adjustment: No	2.82 [1.44;5.51] ^C	31/1,122 12/1,201	43	1,122		ref
S12683 R47919	Alsfouk (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformation	during pregnancy (anytime or not specified)	retrospective cohort	exposed to other treatment, sick excluded	Adjustment: No	1.25 [0.21;7.34] ^C excluded (control group)	5/31 2/15	7	31		ref
S12680 R47916	Alsfouk (Carbamazepine) (Controls unexposed, sick), 2021	Major congenital malformation	during pregnancy (anytime or not specified) excluded	retrospective cohort	unexposed, sick	Adjustment: No	5.58 [0.61;50.91] ^C excluded (exposition period)	5/31 1/30	6	31		ref
S12903 R48938	Hosny (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021	Major birth defects	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.05 [0.00;3.56] ^C excluded (control group)	1/31 0/1	1	31		ref
S12904 R48941	Hosny (Carbamazepine) (Controls unexposed, sick), 2021	Major birth defects	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	0.67 [0.04;11.29] ^C	1/31 1/21	2	31		ref
S12856 R48493	Thomas (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	2.41 [0.32;18.26] ^C excluded (control group)	23/490 1/50	24	490		ref
S12857 R48501	Thomas (Carbamazepine) (Controls unexposed, disease free), 2021	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No	1.57 [0.77;3.20] excluded (control group)	21/389 11/319	32	389		ref
S12858 R48505	Thomas (Carbamazepine) (Controls unexposed, sick), 2021	Major congenital malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: Yes	0.99 [0.50;1.80]	23/490 16/340	39	490		ref
S9595 R33978	AlSheikh (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2020	Fetal/neonatal malformation	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	16.71 [0.56;499.27] ^C excluded (control group)	1/5 0/20	1	5		ref
S9596 R33981	AlSheikh (Carbamazepine) (Controls unexposed, sick), 2020	Fetal/neonatal malformation	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	1.75 [0.08;36.29] ^C excluded (exposition period)	1/5 1/8	2	5		ref
S9632 R34252	Meador (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2020	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	1.62 [0.17;14.92] ^C excluded (control group)	1/14 5/110	6	14		ref
S9633 R34256	Meador (Carbamazepine) (Controls unexposed, disease free), 2020	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No	4.00 [0.34;47.23] ^C excluded (control group)	1/14 2/106	3	14		ref
S9634 R34260	Meador (Carbamazepine) (Controls unexposed, sick), 2020	Major congenital malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	1.08 [0.06;19.05] ^C	1/14 1/15	2	14		ref
S9723 R34624	Huber-Mollema (Carbamazepine), 2019	Congenital malformations	throughout pregnancy	prospective cohort	exposed to other treatment, sick	Adjustment: No	2.55 [0.60;10.78] ^C	4/37 4/88	8	37		ref
S9679 R34459	Vajda (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2019	Fetal malformations	at least 1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	1.20 [0.65;2.21] ^C excluded (control group)	24/409 20/406	44	409		ref
S9680 R34460	Vajda (Carbamazepine) (Controls unexposed, sick), 2019	Fetal malformations	at least 1st trimester	prospective cohort	unexposed, sick	Adjustment: No	2.07 [0.80;5.33]	24/409 5/176	29	409		ref
S9678 R34449	Tomson (Carbamazepine), 2018	Major congenital malformation	at least 1st trimester	prospective cohort	exposed to other treatment, sick	Adjustment: No	1.91 [1.41;2.58] ^C	107/1,957 74/2,514	181	1,957		ref
S9760 R34847	Bank (Carbamazepine) (Mixed indications), 2017	Major Malformation	during pregnancy (anytime or not specified) excluded	prospective cohort	exposed to other treatment, sick	Adjustment: No	16.38 [0.60;447.84] ^C excluded (exposition period)	1/8 0/36	1	8		ref
S9597 R33984	Arkilo (Carbamazepine), 2015	Major malformations	during pregnancy (anytime or not specified) excluded	retrospective cohort	exposed to other treatment, sick	Adjustment: No	1.39 [0.03;73.79] ^C excluded (exposition period)	0/16 0/22	0	16		ref
S9763 R34863	Ban (Carbamazepine) (Mixed indications) (Controls exposed to Lamotrigine, sick), 2015	Any major anomaly	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.86 [0.38;1.91] ^C excluded (control group)	13/343 12/273	25	343		ref
S9764 R34869	Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015	Any major anomaly	1st trimester	prospective cohort	unexposed (general population or NOS)	Adjustment: Yes	1.42 [0.68;2.93]	13/343 6,922/257,153	6,935	343		ref
S9605 R34053	Barroso (Carbamazepine), 2015	Major anomalies	during pregnancy (anytime or not specified) excluded	retrospective cohort	unexposed, disease free	Adjustment: No	1.35 [0.17;10.95] ^C excluded (exposition period)	1/12 20/316	21	12		ref
S9681 R34461	Vanya (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2015	Major congenital malformations	throughout pregnancy	retrospective cohort	exposed to other treatment, sick excluded	Adjustment: No	1.94 [0.07;56.76] ^C excluded (control group)	1/10 0/6	1	10		ref
S9682 R34463	Vanya (Carbamazepine) (Controls unexposed, sick), 2015	Major congenital malformations	throughout pregnancy	retrospective cohort	unexposed, sick	Adjustment: No	6.88 [0.25;186.69] ^C	1/10 0/20	1	10		ref
S9655 R34376	Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014	Major malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	1.10 [0.70;1.70] excluded (control group)	43/1,657 49/2,098	92	1,657		ref
S9656 R34378	Campbell (Carbamazepine) (Controls unexposed, sick), 2014	Major malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	1.08 [0.58;2.03] ^C	43/1,657 13/541	56	1,657		ref
S9643 R34317	Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014	Major congenital malformation	throughout pregnancy	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No Partial overlapping	0.86 [0.48;1.55] ^C excluded (control group)	20/685 28/833	48	685		ref
S9645 R34325	Veiby (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2014	Major malformations	throughout pregnancy	population based cohort retrospective	unexposed, disease free excluded	Adjustment: Yes Partial overlapping	1.06 [0.68;1.66] excluded (control group)	20/685 22,371/771,412	22,391	685		ref
S9646 R34328	Veiby (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014	Major malformations	throughout pregnancy	population based cohort retrospective	unexposed, sick	Adjustment: No Controls: epilepsy indication Partial overlapping	1.04 [0.64;1.69] ^C	20/685 106/3,773	126	685		ref
S9658 R34388	Cassina (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2013	Major congenital anomalies	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	6.94 [0.39;122.72] ^C excluded (control group)	8/120 0/46	8	120		ref
S9659 R34390	Cassina (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2013	Major congenital anomalies	1st trimester	prospective cohort	unexposed, disease free	Adjustment: No	2.22 [0.98;5.05] ^C	8/120 25/803	33	120		ref
S9625 R34223	Källén (Carbamazepine) (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 Partial overlapping	1.13 [0.74;1.72] ^C excluded (control group)	58/1,511 37/1,084	95	1,511		ref
S9626 R34231	Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013	Relatively severe malformations	early pregnancy	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes Partial overlapping	1.04 [0.80;1.35]	58/1,511 49,499/1,575,847	49,557	1,511		ref
S9653 R34363	Bànhidy (Carbamazepine), 2011	Total congenital abnormalities	throughout pregnancy	case control	unexposed, sick	Adjustment: No Matched	0.67 [0.19;2.33] ^C	8/18 12/22	20	18		ref
S9608 R34065	Charlton (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2011	Major congenital malformations	1st trimester	retrospective cohort (claims database)	exposed to other treatment, sick excluded	Adjustment: No	1.38 [0.39;4.95] ^C excluded (control group)	13/311 3/98	16	311		ref
S9609 R34068	Charlton (Carbamazepine) (Controls unexposed, sick), 2011	Major congenital malformations	1st trimester	retrospective cohort (claims database)	unexposed, sick	Adjustment: No	1.71 [0.87;3.36]	13/311 22/902	35	311		ref
S9628 R34240	Mawer (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2010	Major malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.55 [0.07;4.05] ^C excluded (control group)	2/66 2/37	4	66		ref
S9629 R34242	Mawer (Carbamazepine) (Controls unexposed, disease free), 2010	Major malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No Matched	1.45 [0.23;7.37] excluded (control group)	2/66 6/285	8	66		ref
S9630 R34244	Mawer (Carbamazepine) (Controls unexposed, sick), 2010	Major malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	1.25 [0.11;14.24] ^C	2/66 1/41	3	66		ref
S9669 R34417	Kini (Carbamazepine) (Controls unexposed, sick), 2006	Major malformations	during pregnancy (anytime or not specified) excluded	retrospective cohort	unexposed, sick	Adjustment: No	1.36 [0.36;5.23] excluded (exposition period)	5/94 4/101	9	94		ref
S9631 R34246	Meador (Carbamazepine), 2006	Congenital malformations	during pregnancy (anytime or not specified) excluded	prospective cohort	exposed to other treatment, sick	Adjustment: No	4.62 [0.53;40.24] ^C excluded (exposition period)	5/110 1/98	6	110		ref
S9648 R34331	Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006	Major malformations	throughout pregnancy	prospective cohort	unexposed, sick	Adjustment: No	5.26 [0.27;104.15] ^C	3/72 0/52	3	72		ref
S9604 R34049	Barqawi (Carbamazepine), 2005	Major congenital anomalies	during pregnancy (anytime or not specified) excluded	retrospective cohort	unexposed, sick	Adjustment: No	1.13 [0.02;60.37] ^C excluded (exposition period)	0/16 0/18	0	16		ref
S9665 R34412	Kaaja (Carbamazepine), 2003	Major malformation	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	3.36 [0.73;15.46] ^C	10/363 2/239	12	363		ref
S9614 R34143	Dean (Carbamazepine), 2002	Major congenital malformations	at least 1st trimester	retrospective cohort	unexposed, sick	Adjustment: No	2.32 [0.47;11.54] ^C	8/70 2/38	10	70		ref
S9662 R34402	Diav-Citrin (Carbamazepine), 2001	Major congenital anomalies (among live born and elective termination of pregnancy)	at least 1st trimester	prospective cohort	unexposed (general population or NOS)	Adjustment: No Matched	1.98 [0.62;6.30] ^C	6/100 6/192	12	100		ref
S9621 R34201	Holmes (Carbamazepine) (Controls unexposed, disease free), 2001	Major malformations	during pregnancy (anytime or not specified)	retrospective cohort	unexposed, disease free excluded	Adjustment: Yes	3.00 [0.60;16.00] excluded (control group)	3/58 9/508	12	58		ref
S9622 R34210	Holmes (Carbamazepine) (Controls unexposed, sick), 2001	Major malformations	during pregnancy (anytime or not specified) excluded	retrospective cohort	unexposed, sick	Adjustment: No	12.52 [0.63;246.98] ^C excluded (exposition period)	3/58 0/98	3	58		ref
S9623 R34219	Hvas (Carbamazepine) (Controls unexposed, disease free), 2000	Major congenital malformations	1st trimester	retrospective cohort	unexposed, disease free excluded	Adjustment: No	4.81 [1.15;20.08] ^C excluded (control group)	2/37 280/23,827	282	37		ref
S9624 R34221	Hvas (Carbamazepine) (Controls unexposed, sick), 2000	Major congenital malformations	1st trimester	retrospective cohort	unexposed, sick	Adjustment: No	15.29 [0.72;326.31] ^C	2/37 0/106	2	37		ref
S9657 R34386	Canger (Carbamazepine), 1999	Severe malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	3.48 [0.19;63.08] ^C	7/113 0/25	7	113		ref
S9671 R34434	Samrén (Carbamazepine), 1999	Major congential abnormalities	at least 1st trimester	retrospective cohort	unexposed, disease free	Adjustment: No Matched	2.60 [1.40;5.00]	14/376 29/2,000	43	376		ref
S9768 R34928	Nulman (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 1997	Malformations (major)	at least 1st trimester	prospective cohort	unexposed (general population or NOS)	Adjustment: No Matched	1.03 [0.14;7.75] ^C	2/35 2/36	4	35		ref
S9672 R34436	Steegers-Theunissen (Carbamazepine), 1994	Major malformations (ICD9 British Paediatric Association System)	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, disease free	Adjustment: No	2.81 [0.38;20.68] ^C excluded (exposition period)	2/39 2/106	4	39		ref
S9670 R34431	Robert (Carbamazepine), 1986	Major malformations	1st trimester	retrospective cohort	unexposed, sick	Adjustment: No	13.80 [0.22;853.65] ^C	0/3 0/35	0	3		ref
					Total	27 studies	1.48 [1.23;1.77]		205,182	12,653
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

1: Carbamazepine) (Mixed indications) (Controls unexposed, NOS; 2: Carbamazepine; 3: Controls unexposed, disease free) (Indications NOS; 4: Carbamazepine) (Controls unexposed, sick; 5: Carbamazepine) (Controls unexposed, sick; 6: Carbamazepine) (Controls unexposed, sick; 7: Carbamazepine; 8: Carbamazepine) (Controls unexposed, sick; 9: Carbamazepine; 10: Carbamazepine) (Mixed indications) (Controls unexposed NOS; 11: Carbamazepine) (Controls unexposed, sick; 12: Carbamazepine) (Controls unexposed, sick; 13: Carbamazepine) (Controls unexposed, sick) (Mixed indications; 14: Carbamazepine) (Controls unexposed, disease free) (Mixed indications; 15: Carbamazepine) (Controls unexposed, NOS) (Indications NOS; 16: Carbamazepine; 17: Carbamazepine) (Controls unexposed, sick; 18: Carbamazepine) (Controls unexposed, sick; 19: Carbamazepine) (Controls unexposed, sick) ; 20: Carbamazepine; 21: Carbamazepine; 22: Carbamazepine; 23: Carbamazepine) (Controls unexposed, sick; 24: Carbamazepine; 25: Carbamazepine; 26: Carbamazepine) (Controls unexposed, NOS) (Mixed indications; 27: Carbamazepine;

Sensitivity analysis

Publication bias and p-hacking diagnosis

funnel plot

Asymetry test p-value = 0.0000 (by Egger's regression)

slope=0.1210 (0.0945); intercept=0.7606 (0.3039); t=2.5029; p=0.0000

p values plot

Sub-groups analysis using all included studies

excluded 9623, 9621, 9628, 9629, 9608, 9658, 9625, 9655, 9643, 9645, 9763, 9681, 9679, 9595, 9632, 9633, 12683, 12903, 12856, 12857, 10225, 15367, 15199, 15852

S15367 R63239	Bromley (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023	Major congenital anomaly (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	2.75 [0.44;17.33]	2/27 3/106
S15368 R63252	Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023	Major congenital anomaly (68)	during pregnancy (anytime or not specified)	unexposed, sick	2.05 [0.32;13.00]	2/27 3/80
S15199 R62341	Cohen (Carbamazepine) (Mixed indications) (Controls exposed to LTG), 2023	Major congenital malformations (excluding genetic/chromosomal) (68)	1st trimester	exposed to other treatment, sick	0.91 [0.72;1.15]	90/2674 314/8339
S15198 R62334	Cohen (Carbamazepine) (Mixed indications) (Controls unexposed, NOS), 2023	Major congenital malformations (excluding genetic/chromosomal) (68)	1st trimester	unexposed (general population or NOS)	1.11 [0.90;1.37]	90/2674 147928/4866362
S15852 R65260	Li (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023	Major congenital malformation (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	9.55 [0.47;192.46]	3/31 0/38
S15267 R62752	Li (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023	Major congenital malformation (68)	during pregnancy (anytime or not specified)	unexposed, sick	3.77 [0.92;15.39]	3/31 7/253
S12674 R47886	Mari (Carbamazepine), 2022	Major foetal malformation (68)	throughout pregnancy	exposed to other treatment, sick	1.15 [0.04;30.40]	1/29 0/11
S10225 R37454	The NAAED (Controls exposed to Lamotrigine, sick) (Indications NOS), 2022	Major congenital malformations (68)	1st trimester	exposed to other treatment, sick	1.48 [0.93;2.35]	31/1122 44/2333
S10226 R37460	The NAAED (Controls unexposed, disease free) (Indications NOS), 2022	Major congenital malformations (68)	1st trimester	unexposed, disease free	2.82 [1.44;5.51]	31/1122 12/1201
S12683 R47919	Alsfouk (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformation (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	1.25 [0.21;7.34]	5/31 2/15
S12680 R47916	Alsfouk (Carbamazepine) (Controls unexposed, sick), 2021	Major congenital malformation (68)	during pregnancy (anytime or not specified)	unexposed, sick	5.58 [0.61;50.91]	5/31 1/30
S12903 R48938	Hosny (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021	Major birth defects (68)	1st trimester	exposed to other treatment, sick	0.05 [0.00;3.56]	1/31 0/1
S12904 R48941	Hosny (Carbamazepine) (Controls unexposed, sick), 2021	Major birth defects (68)	1st trimester	unexposed, sick	0.67 [0.04;11.29]	1/31 1/21
S12856 R48493	Thomas (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021	Major congenital malformations (68)	1st trimester	exposed to other treatment, sick	2.41 [0.32;18.26]	23/490 1/50
S12857 R48501	Thomas (Carbamazepine) (Controls unexposed, disease free), 2021	Major congenital malformations (68)	1st trimester	unexposed, disease free	1.57 [0.77;3.20]	21/389 11/319
S12858 R48505	Thomas (Carbamazepine) (Controls unexposed, sick), 2021	Major congenital malformations (68)	1st trimester	unexposed, sick	0.99 [0.50;1.80]	23/490 16/340
S9595 R33978	AlSheikh (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2020	Fetal/neonatal malformation (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	16.71 [0.56;499.27]	1/5 0/20
S9596 R33981	AlSheikh (Carbamazepine) (Controls unexposed, sick), 2020	Fetal/neonatal malformation (68)	during pregnancy (anytime or not specified)	unexposed, sick	1.75 [0.08;36.29]	1/5 1/8
S9632 R34252	Meador (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2020	Major congenital malformations (68)	1st trimester	exposed to other treatment, sick	1.62 [0.17;14.92]	1/14 5/110
S9633 R34256	Meador (Carbamazepine) (Controls unexposed, disease free), 2020	Major congenital malformations (68)	1st trimester	unexposed, disease free	4.00 [0.34;47.23]	1/14 2/106
S9634 R34260	Meador (Carbamazepine) (Controls unexposed, sick), 2020	Major congenital malformations (68)	1st trimester	unexposed, sick	1.08 [0.06;19.05]	1/14 1/15
S9723 R34624	Huber-Mollema (Carbamazepine), 2019	Congenital malformations (68)	throughout pregnancy	exposed to other treatment, sick	2.55 [0.60;10.78]	4/37 4/88
S9679 R34459	Vajda (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2019	Fetal malformations (68)	at least 1st trimester	exposed to other treatment, sick	1.20 [0.65;2.21]	24/409 20/406
S9680 R34460	Vajda (Carbamazepine) (Controls unexposed, sick), 2019	Fetal malformations (68)	at least 1st trimester	unexposed, sick	2.07 [0.80;5.33]	24/409 5/176
S9678 R34449	Tomson (Carbamazepine), 2018	Major congenital malformation (68)	at least 1st trimester	exposed to other treatment, sick	1.91 [1.41;2.58]	107/1957 74/2514
S9760 R34847	Bank (Carbamazepine) (Mixed indications), 2017	Major Malformation (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	16.38 [0.60;447.84]	1/8 0/36
S9597 R33984	Arkilo (Carbamazepine), 2015	Major malformations (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	1.39 [0.03;73.79]	0/16 0/22
S9763 R34863	Ban (Carbamazepine) (Mixed indications) (Controls exposed to Lamotrigine, sick), 2015	Any major anomaly (68)	1st trimester	exposed to other treatment, sick	0.86 [0.38;1.91]	13/343 12/273
S9764 R34869	Ban (Carbamazepine) (Mixed indications) (Controls unexposed NOS), 2015	Any major anomaly (68)	1st trimester	unexposed (general population or NOS)	1.42 [0.68;2.93]	13/343 6922/257153
S9605 R34053	Barroso (Carbamazepine), 2015	Major anomalies (68)	during pregnancy (anytime or not specified)	unexposed, disease free	1.35 [0.17;10.95]	1/12 20/316
S9681 R34461	Vanya (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2015	Major congenital malformations (68)	throughout pregnancy	exposed to other treatment, sick	1.94 [0.07;56.76]	1/10 0/6
S9682 R34463	Vanya (Carbamazepine) (Controls unexposed, sick), 2015	Major congenital malformations (68)	throughout pregnancy	unexposed, sick	6.88 [0.25;186.69]	1/10 0/20
S9655 R34376	Campbell (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2014	Major malformations (68)	1st trimester	exposed to other treatment, sick	1.10 [0.70;1.70]	43/1657 49/2098
S9656 R34378	Campbell (Carbamazepine) (Controls unexposed, sick), 2014	Major malformations (68)	1st trimester	unexposed, sick	1.08 [0.58;2.03]	43/1657 13/541
S9643 R34317	Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014	Major congenital malformation (68)	throughout pregnancy	exposed to other treatment, sick	0.86 [0.48;1.55]	20/685 28/833
S9645 R34325	Veiby (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2014	Major malformations (68)	throughout pregnancy	unexposed, disease free	1.06 [0.68;1.66]	20/685 22371/771412
S9646 R34328	Veiby (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 2014	Major malformations (68)	throughout pregnancy	unexposed, sick	1.04 [0.64;1.69]	20/685 106/3773
S9658 R34388	Cassina (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2013	Major congenital anomalies (68)	1st trimester	exposed to other treatment, sick	6.94 [0.39;122.72]	8/120 0/46
S9659 R34390	Cassina (Carbamazepine) (Controls unexposed, disease free) (Mixed indications), 2013	Major congenital anomalies (68)	1st trimester	unexposed, disease free	2.22 [0.98;5.05]	8/120 25/803
S9625 R34223	Källén (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013	Relatively severe malformations (68)	early pregnancy	exposed to other treatment, sick	1.13 [0.74;1.72]	58/1511 37/1084
S9626 R34231	Källén (Carbamazepine) (Controls unexposed, NOS) (Indications NOS), 2013	Relatively severe malformations (68)	early pregnancy	unexposed (general population or NOS)	1.04 [0.80;1.35]	58/1511 49499/1575847
S9653 R34363	Bànhidy (Carbamazepine), 2011	Total congenital abnormalities (68)	throughout pregnancy	unexposed, sick	0.67 [0.19;2.33]	8/18 12/22
S9608 R34065	Charlton (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2011	Major congenital malformations (68)	1st trimester	exposed to other treatment, sick	1.38 [0.39;4.95]	13/311 3/98
S9609 R34068	Charlton (Carbamazepine) (Controls unexposed, sick), 2011	Major congenital malformations (68)	1st trimester	unexposed, sick	1.71 [0.87;3.36]	13/311 22/902
S9628 R34240	Mawer (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2010	Major malformations (68)	1st trimester	exposed to other treatment, sick	0.55 [0.07;4.05]	2/66 2/37
S9629 R34242	Mawer (Carbamazepine) (Controls unexposed, disease free), 2010	Major malformations (68)	1st trimester	unexposed, disease free	1.45 [0.23;7.37]	2/66 6/285
S9630 R34244	Mawer (Carbamazepine) (Controls unexposed, sick), 2010	Major malformations (68)	1st trimester	unexposed, sick	1.25 [0.11;14.24]	2/66 1/41
S9669 R34417	Kini (Carbamazepine) (Controls unexposed, sick), 2006	Major malformations (68)	during pregnancy (anytime or not specified)	unexposed, sick	1.36 [0.36;5.23]	5/94 4/101
S9631 R34246	Meador (Carbamazepine), 2006	Congenital malformations (68)	during pregnancy (anytime or not specified)	exposed to other treatment, sick	4.62 [0.53;40.24]	5/110 1/98
S9648 R34331	Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006	Major malformations (68)	throughout pregnancy	unexposed, sick	5.26 [0.27;104.15]	3/72 0/52
S9604 R34049	Barqawi (Carbamazepine), 2005	Major congenital anomalies (68)	during pregnancy (anytime or not specified)	unexposed, sick	1.13 [0.02;60.37]	0/16 0/18
S9665 R34412	Kaaja (Carbamazepine), 2003	Major malformation (68)	1st trimester	unexposed, sick	3.36 [0.73;15.46]	10/363 2/239
S9614 R34143	Dean (Carbamazepine), 2002	Major congenital malformations (68)	at least 1st trimester	unexposed, sick	2.32 [0.47;11.54]	8/70 2/38
S9662 R34402	Diav-Citrin (Carbamazepine), 2001	Major congenital anomalies (among live born and elective termination of pregnancy) (68)	at least 1st trimester	unexposed (general population or NOS)	1.98 [0.62;6.30]	6/100 6/192
S9621 R34201	Holmes (Carbamazepine) (Controls unexposed, disease free), 2001	Major malformations (68)	during pregnancy (anytime or not specified)	unexposed, disease free	3.00 [0.60;16.00]	3/58 9/508
S9622 R34210	Holmes (Carbamazepine) (Controls unexposed, sick), 2001	Major malformations (68)	during pregnancy (anytime or not specified)	unexposed, sick	12.52 [0.63;246.98]	3/58 0/98
S9623 R34219	Hvas (Carbamazepine) (Controls unexposed, disease free), 2000	Major congenital malformations (68)	1st trimester	unexposed, disease free	4.81 [1.15;20.08]	2/37 280/23827
S9624 R34221	Hvas (Carbamazepine) (Controls unexposed, sick), 2000	Major congenital malformations (68)	1st trimester	unexposed, sick	15.29 [0.72;326.31]	2/37 0/106
S9657 R34386	Canger (Carbamazepine), 1999	Severe malformations (68)	1st trimester	unexposed, sick	3.48 [0.19;63.08]	7/113 0/25
S9671 R34434	Samrén (Carbamazepine), 1999	Major congential abnormalities (68)	at least 1st trimester	unexposed, disease free	2.60 [1.40;5.00]	14/376 29/2000
S9768 R34928	Nulman (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 1997	Malformations (major) (68)	at least 1st trimester	unexposed (general population or NOS)	1.03 [0.14;7.75]	2/35 2/36
S9672 R34436	Steegers-Theunissen (Carbamazepine), 1994	Major malformations (ICD9 British Paediatric Association System) (68)	during pregnancy (anytime or not specified)	unexposed, disease free	2.81 [0.38;20.68]	2/39 2/106
S9670 R34431	Robert (Carbamazepine), 1986	Major malformations (68)	1st trimester	unexposed, sick	13.80 [0.22;853.65]	0/3 0/35