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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S15860 R65277 |
Li (Topiramate) (Controls exposed to LTG), 2023 | Major congenital malformation | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
20.45 [0.74;567.72] C excluded (control group) |
1/7 0/38 | 1 | 7 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15861 R65279 |
Li (Topiramate) (Controls unexposed, sick), 2023 | Major congenital malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
5.86 [0.62;55.37] C excluded (exposition period) |
1/7 7/253 | 8 | 7 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12694 R48034 |
Alsfouk (Topiramate) (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 |
1.67 [0.05;53.93] C excluded (control group) |
0/2 2/15 | 2 | 2 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12696 R48035 |
Alsfouk (Topiramate) (Controls unexposed, sick), 2021 | Major congenital malformation | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
6.33 [0.17;231.15] C excluded (exposition period) |
0/2 1/30 | 1 | 2 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12871 R48602 |
Thomas (Topiramate) (Controls exposed to Lamotrigine, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
1.90 [0.07;50.68] C excluded (control group) |
0/9 1/50 | 1 | 9 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S7555 R27024 |
Thomas (Topiramate) (Controls unexposed, disease free), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
2.43 [0.13;46.65] C excluded (control group) |
0/6 11/319 | 11 | 6 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12872 R48612 |
Thomas (Topiramate) (Controls unexposed, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 1.15 [0.06;20.85] C | 0/9 16/340 | 16 | 9 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8004 R27004 |
AlSheikh (Topiramate) (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 |
39.00 [0.31;4841.77] C excluded (control group) |
0/1 0/20 | 0 | 1 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8005 R27005 |
AlSheikh (Topiramate) (Controls unexposed, sick), 2020 | Fetal/neonatal malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
4.33 [0.06;320.42] C excluded (exposition period) |
0/1 1/8 | 1 | 1 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S7507 R27017 |
Meador (Topiramate) (Controls exposed to Lamotrigine, sick), 2020 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
4.20 [0.41;43.04] C excluded (control group) |
1/6 5/110 | 6 | 6 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S7498 R27018 |
Meador (Topiramate) (Controls unexposed, disease free), 2020 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
10.40 [0.80;134.90] C excluded (control group) |
1/6 2/106 | 3 | 6 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S7503 R27019 |
Meador (Topiramate) (Controls unexposed, sick), 2020 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 2.80 [0.15;53.71] C | 1/6 1/15 | 2 | 6 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S7781 R35173 |
Vajda (Topiramate) (Controls exposed to Lamotrigine, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.37 [0.05;2.82] C excluded (control group) |
1/53 20/406 | 21 | 53 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S7782 R35174 |
Vajda (Topiramate) (Controls unexposed, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.66 [0.09;5.96] | 1/53 5/176 | 6 | 53 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S7662 R27026 |
Tomson (Topiramate), 2018 | Major congenital malformation | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 1.36 [0.58;3.17] C | 6/152 74/2,514 | 80 | 152 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S10275 R37646 |
Razaz (Topiramate) (Controls exposed to Lamotrigine, sick), 2017 | Major malformations | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
3.12 [0.87;11.27] C excluded (control group) |
3/24 22/503 | 25 | 24 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S10274 R37647 |
Razaz (Topiramate) (Controls unexposed, disease free), 2017 | Major malformations | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, disease free excluded | Adjustment: No |
4.22 [1.26;14.15] C excluded (control group) |
3/24 46,632/1,424,279 | 46,635 | 24 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S10273 R37648 |
Razaz (Topiramate) (Controls unexposed, sick), 2017 | Major malformations | during pregnancy (anytime or not specified) excluded | population based cohort retrospective | unexposed, sick | Adjustment: No |
2.92 [0.86;9.99] C excluded (exposition period) |
3/24 87/1,868 | 90 | 24 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6251 R27007 |
Arkilo (Topiramate), 2015 | Major malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | exposed to other treatment, sick | Adjustment: No |
15.67 [0.22;1102.00] C excluded (exposition period) |
0/2 0/24 | 0 | 2 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6239 R27006 |
Babic (Topiramate), 2014 | Major congential malformations | during pregnancy (anytime or not specified) excluded | prospective cohort | exposed to other treatment, sick | Adjustment: No |
15.00 [0.12;1923.88] C excluded (exposition period) |
0/1 0/8 | 0 | 1 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6315 R27027 |
Veiby (Topiramate) (Controls exposed to Lamotrigine, sick), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
1.21 [0.28;5.31] C excluded (control group) |
2/43 23/593 | 25 | 43 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S5528 R27029 |
Veiby (Topiramate) (Controls unexposed, disease free), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes |
1.84 [0.44;7.62] excluded (control group) |
2/43 22,371/771,412 | 22,373 | 43 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6312 R27028 |
Veiby (Topiramate) (Controls unexposed, sick), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No | 1.69 [0.40;7.07] C | 2/43 106/3,773 | 108 | 43 |
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S8253 R27010 |
Hernández-Díaz (Topiramate), 2012 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No Controls: mixed indications | 3.10 [1.60;5.90] | -/- -/- | - | - |
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S8289 R27015 |
Mawer (Topiramate) (Controls exposed to Lamotrigine, sick), 2010 | Major malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.76 [0.10;74.58] C excluded (control group) |
0/3 2/37 | 2 | 3 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8290 R27014 |
Mawer (Topiramate) (Controls unexposed, disease free), 2010 | Major malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
8.57 [0.37;196.88] C excluded (control group) |
0/3 6/285 | 6 | 3 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8294 R27016 |
Mawer (Topiramate) (Controls unexposed, sick), 2010 | Major malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 5.27 [0.17;165.32] C | 0/3 1/41 | 1 | 3 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S5510 R27022 |
Ornoy (Topiramate), 2008 | Non-genetic anomalies | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | 1.44 [0.16;12.74] C | 1/29 5/206 | 6 | 29 |
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ref | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6061 R27020 |
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 | Major congenital malformation | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.29 [0.51;10.30] C excluded (control group) |
2/28 21/647 | 23 | 28 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6062 R27021 |
Morrow (Topiramate) (Controls unexposed, sick), 2006 | Major congenital malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 2.11 [0.42;10.45] C | 2/28 8/227 | 10 | 28 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 9 studies | 2.06 [1.34;3.17] | 229 | 323 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Topiramate) (Controls unexposed, sick; 2: Topiramate) (Controls unexposed, sick; 3: Topiramate) (Controls unexposed, sick; 4: Topiramate; 5: Topiramate) (Controls unexposed, sick; 6: Topiramate; 7: Topiramate) (Controls unexposed, sick; 8: Topiramate; 9: Topiramate) (Controls unexposed, sick;
Asymetry test p-value = 0.3994 (by Egger's regression)
slope=0.9624 (0.3126); intercept=-0.4246 (0.4732); t=0.8972; p=0.3994
excluded 6061, 8289, 8290, 6315, 5528, 10275, 10274, 7781, 8004, 7507, 7498, 12694, 12871, 7555, 15860