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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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S16194 R67117 |
The NAAED (Controls exposed to LTG) (Indications NOS), 2024 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
1.54 [0.37;6.49] C excluded (control group) |
2/62 52/2,461 | 54 | 62 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S16184 R67118 |
The NAAED (Controls unexposed, disease free) (Indications NOS), 2024 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 2.88 [0.64;12.88] C | 2/62 15/1,311 | 17 | 62 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15251 R62701 |
Dudukina (Controls exposed to LTG) (Mixed indications), 2023 | Major congenital malformations | 3 months or more before pregnancy or1st trimester | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: Yes |
1.25 [0.98;1.59] excluded (control group) |
138/2,332 351/7,005 | 489 | 2,332 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15252 R62722 |
Dudukina (Controls unexposed, NOS) (Mixed indications), 2023 | Major congenital malformations | 3 months or more before pregnancy or1st trimester excluded | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes |
1.14 [0.96;1.35] excluded (exposition period) |
138/2,332 126,437/3,063,173 | 126,575 | 2,332 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8530 R35199 |
Vajda (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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8531 R35200 |
Vajda (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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8529 R28290 |
Tomson, 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8528 R28288 |
Patorno_MAX and MaketScan (Other indications), 2017 | Major congenital malformations (MAX and Marketscan data) | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 0.99 [0.66;1.47] | 24/471 38,116/1,750,259 | 38,140 | 471 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8525 R28238 |
Winterfeld (Other indications), 2016 | Overall major birth defects | 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No Matched | 6.50 [1.70;24.70] | 3/19 16/573 | 19 | 19 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8534 R28300 |
Veiby (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 |
0.99 [0.13;7.54] C excluded (control group) |
1/30 28/833 | 29 | 30 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8535 R28302 |
Veiby (Controls unexposed, disease free) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: No |
1.15 [0.16;8.48] C excluded (control group) |
1/30 22,371/771,412 | 22,372 | 30 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8536 R28306 |
Veiby (Controls unexposed, sick) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication | 1.19 [0.16;8.84] C | 1/30 106/3,773 | 107 | 30 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8532 R28294 |
Källén (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 |
0.52 [0.12;2.18] C excluded (control group) |
2/111 37/1,084 | 39 | 111 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8533 R28296 |
Källén (Controls unexposed, NOS) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: No | 0.57 [0.14;2.29] C | 2/111 49,499/1,575,847 | 49,501 | 111 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 7 studies | 1.87 [0.83;4.23] | 87,863 | 698 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Controls unexposed, disease free) (Indications NOS; 2: Controls unexposed, sick; 3: Other indications; 4: Other indications; 5: Controls unexposed, sick) (Mixed indications; 6: Controls unexposed, NOS) (Indications NOS;
Asymetry test p-value = 0.1213 (by Egger's regression)
slope=-0.2748 (0.3326); intercept=1.3174 (0.7067); t=1.8641; p=0.1213
excluded 8532, 8534, 8535, 8535, 8530, 15251, 16194