id | Study | Lib. in paper | Exposition period | Study type |
Control type |
Tags | OR 95%CI | x1/n1 x0/n0 | no cases | no exposed | ROB | Ref. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
S15218 R62396 |
Bromley (Lamotrigine) (Epilepsy), 2023 | Any congenital anomaly | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
2.20 [0.67;7.18] C excluded (exposition period) |
11/106 4/80 | 15 | 106 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15197 R62376 |
Cohen (Lamotrigine) (Mixed indications), 2023 | Major congenital malformations (excluding genetic/chromosomal) | 1st trimester | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes Partial overlapping | 0.97 [0.87;1.08] | 314/8,339 147,928/4,866,362 | 148,242 | 8,339 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15263 R62763 |
Li (Lamotrigine) (Epilepsy), 2023 | Major congenital malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
0.44 [0.02;7.80] C excluded (exposition period) |
0/38 7/253 | 7 | 38 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15213 R62387 |
Pekoz (Lamotrigine) (Epilepsy), 2023 | Congenital malformations (major and minor) | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
0.91 [0.09;9.01] C excluded (exposition period) |
3/141 1/43 | 4 | 141 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8968 R30372 |
The NAAED (Indications NOS), 2022 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 1.90 [1.00;3.62] C | 44/2,333 12/1,201 | 56 | 2,333 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12678 R48016 |
Alsfouk (Lamotrigine), 2021 | Major congenital malformation | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
4.46 [0.37;53.71] C excluded (exposition period) |
2/15 1/30 | 3 | 15 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12677 R47911 |
Hosny, 2021 | Major birth defects | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 2.60 [0.08;82.80] C | 0/3 1/21 | 1 | 3 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8923 R30162 |
Thomas (Lamotrigine) (Controls unexposed, disease free), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
0.76 [0.10;5.75] excluded (control group) |
1/38 11/319 | 12 | 38 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8924 R48247 |
Thomas (Lamotrigine) (Controls unexposed, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: Yes | 0.50 [0.10;3.70] | 1/50 16/340 | 17 | 50 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8901 R30054 |
AlSheikh (Lamotrigine), 2020 | Fetal/neonatal malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
0.11 [0.00;3.08] C excluded (exposition period) |
0/20 1/8 | 1 | 20 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8904 R30086 |
Aydin (Lamotrigine), 2020 | Congenital chromosomal/structural anomalies | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 3.31 [0.06;183.69] C | 0/7 0/22 | 0 | 7 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8911 R30116 |
Meador (Lamotrigine) (Controls unexposed, disease free), 2020 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
2.48 [0.47;13.05] C excluded (control group) |
5/110 2/106 | 7 | 110 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8912 R30120 |
Meador (Lamotrigine) (Controls unexposed, sick), 2020 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.67 [0.07;6.13] C | 5/110 1/15 | 6 | 110 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12464 R46886 |
Kernizan, 2019 | Malformation | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
0.75 [0.09;6.21] C excluded (exposition period) |
1/13 14/140 | 15 | 13 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8925 R35142 |
Vajda (Lamotrigine), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 1.75 [0.66;4.55] | 20/406 5/176 | 25 | 406 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S10208 R37659 |
Petersen (Lamotrigine) (Controls unexposed NOS), 2017 | Major congenital malformation | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) excluded | Adjustment: Yes |
0.95 [0.51;1.79] excluded (control group) |
10/357 5,315/239,151 | 5,325 | 357 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S10209 R37660 |
Petersen (Lamotrigine) (Controls unexposed, sick), 2017 | Major congenital malformation | 1st trimester | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes | 0.88 [0.44;1.75] | 9/344 86/2,844 | 95 | 344 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8926 R30167 |
Vanya (Lamotrigine) (Controls unexposed, sick), 2015 | Major congenital malformations | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 3.55 [0.06;199.99] C | 0/6 0/20 | 0 | 6 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8917 R30139 |
Campbell (Lamotrigine), 2014 | Major malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.97 [0.52;1.80] C | 49/2,098 13/541 | 62 | 2,098 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8964 R30361 |
Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes Partial overlapping |
1.26 [0.87;1.84] excluded (control group) |
28/833 22,371/771,412 | 22,399 | 833 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8965 R30364 |
Veiby (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication Partial overlapping | 1.20 [0.79;1.84] C | 28/833 106/3,773 | 134 | 833 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8966 R30366 |
Cassina (Lamotrigine) (Mixed indications), 2013 | Major congenital anomalies | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 0.34 [0.02;5.59] C | 0/46 25/803 | 25 | 46 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8908 R30108 |
Källén (Lamotrigine) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes Partial overlapping | 1.08 [0.78;1.50] | 37/1,084 49,499/1,575,847 | 49,536 | 1,084 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8952 R30268 |
Rihtman (Lamotrigine), 2013 | Children: born with congenital deformation | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No | 6.52 [0.30;139.67] C | 2/42 0/52 | 2 | 42 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8905 R30091 |
Charlton (Lamotrigine), 2011 | Major congenital malformations | 1st trimester | retrospective cohort (claims database) | unexposed, sick | Adjustment: No | 1.26 [0.38;4.17] | 3/98 22/902 | 25 | 98 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8909 R30110 |
Mawer (Lamotrigine) (Controls unexposed, disease free), 2010 | Major malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
2.66 [0.52;13.68] excluded (control group) |
2/37 6/285 | 8 | 37 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8910 R30112 |
Mawer (Lamotrigine) (Controls unexposed, sick), 2010 | Major malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 2.29 [0.20;26.30] C | 2/37 1/41 | 3 | 37 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8919 R30145 |
Dean (Lamotrigine), 2007 | Major malformation | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
1.73 [0.07;40.78] C excluded (exposition period) |
0/4 3/46 | 3 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 16 studies | 1.01 [0.92;1.11] | 198,229 | 15,836 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 |
1: Lamotrigine) (Mixed indications; 2: Indications NOS; 3: Lamotrigine) (Controls unexposed, sick; 4: Lamotrigine; 5: Lamotrigine) (Controls unexposed, sick; 6: Lamotrigine; 7: Lamotrigine) (Controls unexposed, sick; 8: Lamotrigine) (Controls unexposed, sick; 9: Lamotrigine; 10: Lamotrigine) (Controls unexposed, sick) (Mixed indications; 11: Lamotrigine) (Mixed indications; 12: Lamotrigine) (Indications NOS; 13: Lamotrigine; 14: Lamotrigine; 15: Lamotrigine) (Controls unexposed, sick;
Asymetry test p-value = 0.0716 (by Egger's regression)
slope=-0.0399 (0.0461); intercept=0.4627 (0.2374); t=1.9493; p=0.0716
excluded 8909, 8964, 10208, 8911, 8923