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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S15206 R62381 |
Cohen (Topiramate) (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 |
1.81 [1.26;2.60] excluded (control group) |
32/509 314/8,339 | 346 | 509 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15207 R62382 |
Cohen (Topiramate) (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 | 2.14 [1.50;3.06] C | 32/509 147,928/4,866,362 | 147,960 | 509 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15268 R62768 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15269 R62769 |
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 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8597 R28624 |
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 |
2.61 [1.57;4.33] C excluded (control group) |
24/503 44/2,333 | 68 | 503 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8598 R28626 |
The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 4.96 [2.46;10.01] C | 24/503 12/1,201 | 36 | 503 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12693 R48033 |
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 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12695 R48032 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12873 R48622 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12874 R48630 |
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 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12875 R48634 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8552 R28454 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8553 R28457 |
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 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8564 R28487 |
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 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8565 R28491 |
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 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8566 R28495 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8576 R35171 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8577 R35172 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8575 R28534 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8602 R28640 |
Bank (Topiramate) (Mixed indications) , 2017 | Major Malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | exposed to other treatment, sick | Adjustment: No |
23.67 [0.34;1653.93] C excluded (exposition period) |
0/2 0/36 | 0 | 2 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8554 R28464 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8555 R28467 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8594 R28610 |
Veiby (Topiramate) (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 |
1.25 [0.29;5.41] C excluded (control group) |
2/48 28/833 | 30 | 48 |
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S8595 R28614 |
Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes Partial overlapping |
1.66 [0.40;6.85] excluded (control group) |
2/48 22,371/771,412 | 22,373 | 48 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8596 R28618 |
Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication Partial overlapping | 1.50 [0.36;6.28] C | 2/48 106/3,773 | 108 | 48 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8559 R28475 |
Källén (Topiramate) (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 |
3.95 [1.58;9.86] C excluded (control group) |
6/49 37/1,084 | 43 | 49 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8560 R28477 |
Källén (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes Partial overlapping | 3.73 [1.97;8.11] | 6/49 49,499/1,575,847 | 49,505 | 49 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8568 R28506 |
Margulis (Topiramate) (Mixed indication), 2012 | Major congenital malformations | 1st trimester | case control | unexposed (general population or NOS) | Adjustment: No Matched | 1.01 [0.37;3.22] | 15/21 33,605/48,972 | 33,620 | 21 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8561 R28479 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8562 R28481 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8563 R28483 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8571 R28518 |
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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8569 R28514 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8570 R28516 |
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 | 12 studies | 2.27 [1.66;3.10] | 231,350 | 1,410 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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) (Mixed indications) (Controls unexposed, NOS; 2: Controls unexposed, disease free) (Indications NOS; 3: Topiramate) (Controls unexposed, sick; 4: Topiramate) (Controls unexposed, sick; 5: Topiramate) (Controls unexposed, sick; 6: Topiramate; 7: Topiramate) (Controls unexposed, sick) (Mixed indications; 8: Topiramate) (Controls unexposed, NOS) (Indications NOS; 9: Topiramate) (Mixed indication; 10: Topiramate) (Controls unexposed, sick; 11: Topiramate; 12: Topiramate) (Controls unexposed, sick;
Asymetry test p-value = 0.4873 (by Egger's regression)
slope=0.9626 (0.2345); intercept=-0.3794 (0.5260); t=0.7212; p=0.4873
excluded 8569, 8561, 8562, 8559, 8594, 8595, 8576, 8552, 8564, 8565, 12693, 12873, 12874, 8597, 15206, 15268