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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S18028 R75969 |
Hao (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2025 | Major congenital malformation (MCM) | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.83 [0.22;3.21] C excluded (control group) |
8/268 3/84 | 11 | 268 |
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S18019 R75968 |
Hao (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2025 | Major congenital malformation (MCM) | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.63 [0.30;1.31] | 8/268 10/261 | 18 | 268 |
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S16102 R66793 |
Battino (Levetiracetam) (Epilepsy), 2024 | Major congenital malformations (MCMs) | early pregnancy | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 0.79 [0.53;1.19] | 33/1,325 110/3,584 | 143 | 1,325 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S16804 R70508 |
Ertürk Çetin (Epilepsy) (Levetiracetam), 2024 | Major congenital malformations | throughout pregnancy | prospective cohort | exposed to other treatment, sick | Adjustment: No | 0.43 [0.01;23.69] C | 0/18 0/8 | 0 | 18 |
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S16096 R66788 |
Hoeltzenbein (Levetiracetam), 2024 | Major birth defects | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 1.41 [0.58;3.44] | 12/207 17/442 | 29 | 207 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S18049 R76019 |
Vajda b (Levetiracetam) (Epilepsy) (Controls exposed to Lamotrigine, sick), 2024 | Fetal malformations | early pregnancy | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.88 [0.37;2.12] C excluded (control group) |
7/187 20/473 | 27 | 187 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S18050 R76021 |
Vajda b (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2024 | Fetal malformations | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 1.07 [0.38;3.00] | 7/187 7/201 | 14 | 187 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S17500 R73529 |
Wiggs (Epilepsy) (Levetiracetam), 2024 | Major birth defects | early pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 0.68 [0.17;2.76] | -/185 -/9,364 | - | 185 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15220 R62423 |
Bromley (Levetiracetam) (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 |
1.01 [0.16;6.20] C excluded (control group) |
2/70 3/106 | 5 | 70 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15219 R62410 |
Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 | Major congenital anomaly | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
0.75 [0.12;4.65] C excluded (exposition period) |
2/70 3/80 | 5 | 70 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15204 R62364 |
Cohen (Levetiracetam) (Epilepsy) (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 |
0.78 [0.53;1.13] excluded (control group) |
30/1,040 314/8,339 | 344 | 1,040 |
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S15205 R62365 |
Cohen (Levetiracetam) (Epilepsy) (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 | 0.95 [0.66;1.36] C | 30/1,040 147,928/4,866,362 | 147,958 | 1,040 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15260 R62745 |
Li (Levetiracetam) (Controls exposed to LTG), 2023 | Major congenital malformation | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.35 [0.01;18.06] C excluded (control group) |
0/107 0/38 | 0 | 107 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15259 R62743 |
Li (Levetiracetam) (Controls unexposed, sick), 2023 | Major congenital malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
0.15 [0.01;2.72] C excluded (exposition period) |
0/107 7/253 | 7 | 107 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S16185 R67077 |
The NAAED (Levetiracetam) (Controls exposed to LTG) (Indications NOS), 2023 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.96 [0.60;1.54] C excluded (control group) |
26/1,283 52/2,461 | 78 | 1,283 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S16175 R67067 |
The NAAED (Levetiracetam) (Controls unexposed, disease free) (Indications NOS), 2023 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 1.79 [0.94;3.39] C | 26/1,283 15/1,311 | 41 | 1,283 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12676 R47906 |
Mari (Levetiracetam), 2022 | Major foetal malformation | throughout pregnancy | retrospective cohort | exposed to other treatment, sick | Adjustment: No | 0.64 [0.01;34.59] C | 0/17 0/11 | 0 | 17 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12687 R47923 |
Alsfouk (Levetiracetam) (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 |
0.11 [0.00;2.39] C excluded (control group) |
0/24 2/15 | 2 | 24 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12685 R47921 |
Alsfouk (Levetiracetam) (Controls unexposed, sick), 2021 | Major congenital malformation | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
0.40 [0.02;10.39] C excluded (exposition period) |
0/24 1/30 | 1 | 24 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12886 R48695 |
Hosny (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2021 | Major birth defects | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.04 [0.00;2.38] C excluded (control group) |
2/67 0/1 | 2 | 67 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12887 R48698 |
Hosny (Levetiracetam) (Controls unexposed, sick), 2021 | Major birth defects | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.62 [0.05;7.15] C | 2/67 1/21 | 3 | 67 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12825 R48275 |
Thomas (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.43 [0.28;21.33] C excluded (control group) |
5/106 1/50 | 6 | 106 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12826 R48283 |
Thomas (Levetiracetam) (Controls unexposed, disease free), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
0.97 [0.13;7.23] excluded (control group) |
1/30 11/319 | 12 | 30 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12827 R48287 |
Thomas (Levetiracetam) (Controls unexposed, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: Yes | 1.16 [0.40;3.10] | 5/106 16/340 | 21 | 106 |
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S16156 R67046 |
Alsaadi (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2020 | Major congenital malformations | 1st trimester | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.95 [0.04;24.83] C excluded (control group) |
1/38 0/12 | 1 | 38 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S16153 R67034 |
Alsaadi (Levetiracetam) (Epilepsy) (Controls unexposed sick), 2020 | Major congenital malformations | 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 0.95 [0.06;15.71] C | 1/38 1/36 | 2 | 38 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8980 R30462 |
AlSheikh (Levetiracetam) (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 |
2.29 [0.04;125.50] C excluded (control group) |
0/9 0/20 | 0 | 9 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8981 R30465 |
AlSheikh (Levetiracetam) (Controls unexposed, sick), 2020 | Fetal/neonatal malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
0.25 [0.01;7.34] C excluded (exposition period) |
0/9 1/8 | 1 | 9 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8995 R30552 |
Meador (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
1.14 [0.32;4.07] C excluded (control group) |
5/97 5/110 | 10 | 97 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8996 R30556 |
Meador (Levetiracetam) (Controls unexposed, disease free), 2020 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
2.83 [0.54;14.92] C excluded (control group) |
5/97 2/106 | 7 | 97 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8997 R30560 |
Meador (Levetiracetam) (Controls unexposed, sick), 2020 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.76 [0.08;7.00] C | 5/97 1/15 | 6 | 97 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9001 R30573 |
Koc (Levetiracetam), 2018 | Major congenital malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
1.11 [0.02;57.82] C excluded (exposition period) |
0/28 0/31 | 0 | 28 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9029 R30784 |
Bank (Levetiracetam) (Mixed indications), 2017 | Major Malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | exposed to other treatment, sick | Adjustment: No |
5.46 [0.10;300.64] C excluded (exposition period) |
0/7 0/36 | 0 | 7 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8982 R30468 |
Arkilo (Levetiracetam), 2015 | Major malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | exposed to other treatment, sick | Adjustment: No |
2.24 [0.04;120.61] C excluded (exposition period) |
0/11 0/24 | 0 | 11 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8988 R30531 |
Babic (Levetiracetam), 2014 | Major congential malformations | during pregnancy (anytime or not specified) excluded | prospective cohort | exposed to other treatment, sick | Adjustment: No |
2.14 [0.03;131.94] C excluded (exposition period) |
0/4 0/8 | 0 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8998 R30562 |
Veiby (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No Partial overlapping |
0.44 [0.10;1.90] C excluded (control group) |
2/114 23/593 | 25 | 114 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8999 R30566 |
Veiby (Levetiracetam) (Controls unexposed, disease free), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes Partial overlapping |
0.66 [0.16;2.67] excluded (control group) |
2/114 22,371/771,412 | 22,373 | 114 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9000 R30568 |
Veiby (Levetiracetam) (Controls unexposed, sick), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No Partial overlapping | 0.62 [0.15;2.53] C | 2/114 106/3,773 | 108 | 114 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9002 R30575 |
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 | Major congenital malformation | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.68 [0.04;11.54] C excluded (control group) |
0/22 21/647 | 21 | 22 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9003 R30583 |
Morrow (Levetiracetam) (Controls unexposed, sick), 2006 | Major congenital malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.60 [0.03;10.72] C | 0/22 8/227 | 8 | 22 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 15 studies | 0.94 [0.76;1.16] | 148,351 | 4,974 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Levetiracetam) (Epilepsy) (Controls unexposed, sick; 2: Levetiracetam) (Epilepsy; 3: Epilepsy) (Levetiracetam; 4: Levetiracetam; 5: Levetiracetam) (Epilepsy) (Controls unexposed, sick; 6: Epilepsy) (Levetiracetam; 7: Levetiracetam) (Epilepsy) (Controls unexposed, NOS; 8: Levetiracetam) (Controls unexposed, disease free) (Indications NOS; 9: Levetiracetam; 10: Levetiracetam) (Controls unexposed, sick; 11: Levetiracetam) (Controls unexposed, sick; 12: Levetiracetam) (Epilepsy) (Controls unexposed sick; 13: Levetiracetam) (Controls unexposed, sick; 14: Levetiracetam) (Controls unexposed, sick; 15: Levetiracetam) (Controls unexposed, sick;
Asymetry test p-value = 0.6435 (by Egger's regression)
slope=-0.0097 (0.1337); intercept=-0.1534 (0.3238); t=0.4738; p=0.6435
excluded 9002, 8998, 8999, 16156, 8980, 8995, 8996, 12687, 12886, 12825, 12826, 15220, 15204, 15260, 16185, 18049, 18028