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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S15200 R62383 |
Cohen (Valproate) (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 |
2.05 [1.70;2.46] excluded (control group) |
159/2,031 314/8,339 | 473 | 2,031 |
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S15201 R62384 |
Cohen (Valproate) (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 | 2.71 [2.30;3.19] C | 159/2,031 147,928/4,866,362 | 148,087 | 2,031 |
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S15264 R62770 |
Li (Valproate) (Controls exposed to LTG), 2023 | Major congenital malformation | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
6.58 [0.30;142.47] C excluded (control group) |
2/31 0/38 | 2 | 31 |
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S15265 R62771 |
Li (Valproate) (Controls unexposed, sick), 2023 | Major congenital malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
2.42 [0.48;12.22] C excluded (exposition period) |
2/31 7/253 | 9 | 31 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15216 R62390 |
Pekoz (Valproate) (Epilepsy) (Controls exposed to LTG), 2023 | Congenital malformations (major and minor) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
4.29 [1.08;17.09] C excluded (control group) |
7/82 3/141 | 10 | 82 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15217 R62391 |
Pekoz (Valproate) (Epilepsy) (Controls unexposed, sick), 2023 | Congenital malformations (major and minor) | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
3.92 [0.47;32.96] C excluded (exposition period) |
7/82 1/43 | 8 | 82 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9304 R32410 |
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 |
5.29 [3.29;8.50] C excluded (control group) |
31/336 44/2,333 | 75 | 336 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9305 R32412 |
The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 10.07 [5.11;19.84] C | 31/336 12/1,201 | 43 | 336 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12689 R48835 |
Alsfouk (Valproate) (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 |
0.22 [0.01;5.02] C excluded (control group) |
0/12 2/15 | 2 | 12 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12691 R48836 |
Alsfouk (Valproate) (Controls unexposed, sick), 2021 | Major congenital malformation | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
0.83 [0.03;21.80] C excluded (exposition period) |
0/12 1/30 | 1 | 12 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12882 R48685 |
Hosny (Valproate) (Controls exposed to Lamotrigine, sick), 2021 | Major birth defects | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.07 [0.00;8.55] C excluded (control group) |
0/8 0/1 | 0 | 8 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12883 R48688 |
Hosny (Valproate) (Controls unexposed, sick), 2021 | Major birth defects | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.87 [0.03;23.72] C | 0/8 1/21 | 1 | 8 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12862 R48537 |
Thomas (Valproate) (Controls exposed to Lamotrigine, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
4.21 [0.56;31.72] C excluded (control group) |
27/341 1/50 | 28 | 341 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12863 R48545 |
Thomas (Valproate) (Controls unexposed, disease free), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
2.60 [1.30;5.20] excluded (control group) |
24/268 11/319 | 35 | 268 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12864 R48549 |
Thomas (Valproate) (Controls unexposed, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: Yes | 1.71 [0.90;3.20] | 27/341 16/340 | 43 | 341 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9280 R32191 |
AlSheikh (Valproate) (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 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9281 R32194 |
AlSheikh (Valproate) (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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9287 R32246 |
Aydin (Valproate) (Controls exposed to Lamotrigine, sick), 2020 | Congenital chromosomal/structural anomalies | throughout pregnancy | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.62 [0.01;35.19] C excluded (control group) |
0/11 0/7 | 0 | 11 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9288 R32256 |
Aydin (Valproate) (Controls unexposed, sick), 2020 | Congenital chromosomal/structural anomalies | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 2.05 [0.04;110.56] C | 0/11 0/22 | 0 | 11 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9404 R32973 |
Huber-Mollema (Valproate), 2019 | Congenital malformations | throughout pregnancy | prospective cohort | exposed to other treatment, sick | Adjustment: No | 6.30 [1.62;24.45] C | 6/26 4/88 | 10 | 26 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9324 R32498 |
Putignano (Valproate), 2019 | Congenital malformations (ICD-9 740 to 760 and 658.8) | throughout pregnancy | retrospective cohort | unexposed (general population or NOS) | Adjustment: No Matched | 3.17 [1.61;6.25] C | 12/79 49/917 | 61 | 79 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9360 R35175 |
Vajda (Valproate) (Controls exposed to Lamotrigine, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
3.36 [1.93;5.85] C excluded (control group) |
43/290 20/406 | 63 | 290 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9361 R35176 |
Vajda (Valproate) (Controls unexposed, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 5.22 [2.11;12.95] | 43/290 5/176 | 48 | 290 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9452 R33252 |
Elkjaer (Valproate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2018 | Malformation in child within first year of life (ICD-10 Q0 to Q99) | during pregnancy (anytime or not specified) | population based cohort propective | exposed to other treatment, sick excluded | Adjustment: No Controls: mixed indications |
2.16 [1.24;3.78] C excluded (control group) |
31/253 24/396 | 55 | 253 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9453 R33256 |
Elkjaer (Valproate) (Controls unexposed NOS) (Mixed indications), 2018 | Malformation in child within first year of life (ICD-10 Q0 to Q99) | during pregnancy (anytime or not specified) excluded | population based cohort propective | unexposed (general population or NOS) | Adjustment: No |
2.65 [1.82;3.86] C excluded (exposition period) |
31/253 23,858/477,162 | 23,889 | 253 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9359 R32743 |
Tomson (Valproate), 2018 | Major congenital malformation | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 3.78 [2.83;5.05] C | 142/1,381 74/2,514 | 216 | 1,381 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9314 R32451 |
Bank (Valproate) (Mixed indications), 2017 | Major Malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | exposed to other treatment, sick | Adjustment: No |
6.45 [0.12;360.09] C excluded (exposition period) |
0/6 0/36 | 0 | 6 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S10210 R37661 |
Petersen (Valproate) (Controls exposed to Lamotrigine, sick), 2017 | Major congenital malformation | 1st trimester | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
2.53 [1.01;6.36] C excluded (control group) |
10/157 9/344 | 19 | 157 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S10211 R37662 |
Petersen (Valproate) (Controls unexposed NOS), 2017 | Major congenital malformation | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) excluded | Adjustment: Yes |
1.94 [1.05;3.61] excluded (control group) |
10/176 5,315/239,151 | 5,325 | 176 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S10212 R37663 |
Petersen (Valproate) (Controls unexposed, sick), 2017 | Major congenital malformation | 1st trimester | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes | 2.14 [1.11;4.13] | 10/157 86/2,844 | 96 | 157 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9282 R32201 |
Arkilo (Valproate), 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 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9362 R32747 |
Vanya (Valproate) (Controls exposed to Lamotrigine, sick), 2015 | Major congenital malformations | throughout pregnancy | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
5.21 [0.23;116.22] C excluded (control group) |
4/14 0/6 | 4 | 14 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9363 R32749 |
Vanya (Valproate) (Controls unexposed, sick), 2015 | Major congenital malformations | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 18.47 [0.90;379.67] C | 4/14 0/20 | 4 | 14 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9289 R32261 |
Babic (Valproate), 2014 | Major congential malformations | during pregnancy (anytime or not specified) excluded | prospective cohort | exposed to other treatment, sick | Adjustment: No |
1.67 [0.03;99.62] C excluded (exposition period) |
0/5 0/8 | 0 | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9333 R32569 |
Campbell (Valproate) (Controls exposed to Lamotrigine, sick), 2014 | Major malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
3.00 [2.10;4.00] excluded (control group) |
82/1,220 49/2,098 | 131 | 1,220 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9334 R32571 |
Campbell (Valproate) (Controls unexposed, sick), 2014 | Major malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 2.93 [1.62;5.30] | 82/1,220 13/541 | 95 | 1,220 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9325 R32519 |
Veiby (Valproate) (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 |
1.94 [1.08;3.46] C excluded (control group) |
21/333 28/833 | 49 | 333 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9326 R32523 |
Veiby (Valproate) (Controls unexposed, disease free) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes Partial overlapping |
2.47 [1.58;3.84] excluded (control group) |
21/333 22,371/771,412 | 22,392 | 333 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9327 R32526 |
Veiby (Valproate) (Controls unexposed, sick) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication Partial overlapping | 2.33 [1.44;3.77] C | 21/333 106/3,773 | 127 | 333 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9336 R32581 |
Cassina (Valproate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2013 | Major congenital anomalies | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
5.21 [0.29;94.43] C excluded (control group) |
6/120 0/46 | 6 | 120 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9337 R32583 |
Cassina (Valproate) (Controls unexposed, disease free) (Mixed indications), 2013 | Major congenital anomalies | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 1.64 [0.66;4.08] C | 6/120 25/803 | 31 | 120 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9309 R32431 |
Källén (Valproate) (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 |
2.76 [1.82;4.20] C excluded (control group) |
62/697 37/1,084 | 99 | 697 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9310 R32439 |
Källén (Valproate) (Controls unexposed, NOS) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes Partial overlapping | 2.30 [1.82;2.91] | 62/697 49,499/1,575,847 | 49,561 | 697 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9450 R33186 |
Rihtman (Valproate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2013 | Children: born with congenital deformation | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No Controls: epilepsy indication |
6.31 [0.67;59.59] C excluded (control group) |
4/30 1/42 | 5 | 30 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9451 R33221 |
Rihtman (Valproate) (Controls unexposed, NOS) (Mixed indications), 2013 | Children: born with congenital deformation | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No | 18.18 [0.94;350.80] C | 4/30 0/52 | 4 | 30 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9286 R32238 |
Arteaga-Vázquez (Valproate), 2012 | Congenital malformations | 1st trimester | case control | unexposed, sick | Adjustment: No | 2.54 [0.55;11.69] C | 4/8 13/46 | 17 | 8 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9331 R35133 |
Bànhidy (Valproate), 2011 | Total congenital abnormalities | throughout pregnancy | case control | unexposed, sick | Adjustment: No Matched | 1.17 [0.28;4.84] C | 7/12 12/22 | 19 | 12 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9293 R32279 |
Charlton (Valproate) (Controls exposed to Lamotrigine, sick), 2011 | Major congenital malformations | 1st trimester | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
1.63 [0.44;5.97] C excluded (control group) |
11/225 3/98 | 14 | 225 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9294 R32282 |
Charlton (Valproate) (Controls unexposed, sick), 2011 | Major congenital malformations | 1st trimester | retrospective cohort (claims database) | unexposed, sick | Adjustment: No | 2.00 [0.99;4.07] | 11/225 22/902 | 33 | 225 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9312 R32442 |
Mawer (Valproate) (Controls exposed to Lamotrigine, sick), 2010 | Major malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.23 [0.43;11.74] C excluded (control group) |
6/53 2/37 | 8 | 53 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9317 R32467 |
Mawer (Valproate) (Controls unexposed, disease free), 2010 | Major malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
5.94 [1.84;19.19] excluded (control group) |
6/53 6/285 | 12 | 53 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9318 R32469 |
Mawer (Valproate) (Controls unexposed, sick), 2010 | Major malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 5.11 [0.59;44.22] C | 6/53 1/41 | 7 | 53 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9444 R33169 |
Diav-Citrin (Valproate) (Mixed indications), 2008 | Major anomalies without chromosomal or genetic anomalies | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No | 1.71 [0.51;5.75] C | 3/71 31/1,236 | 34 | 71 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9290 R32264 |
Burja (Valproate) (Controls unexposed, disease free), 2006 | Congenital malformation | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, disease free excluded | Adjustment: No |
12.45 [0.45;341.34] C excluded (control group) |
0/2 5/211 | 5 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9292 R32274 |
Burja (Valproate) (Controls unexposed, sick), 2006 | Congenital malformation | during pregnancy (anytime or not specified) excluded | retrospective cohort (registry) | unexposed, sick | Adjustment: No |
21.00 [0.30;1469.95] C excluded (exposition period) |
0/2 0/32 | 0 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9346 R32608 |
Kini (Valproate) (Controls unexposed, sick), 2006 | Major malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
4.04 [1.19;13.74] excluded (exposition period) |
9/63 4/101 | 13 | 63 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9319 R32473 |
Meador (Valproate), 2006 | Congenital malformations | during pregnancy (anytime or not specified) excluded | prospective cohort | exposed to other treatment, sick | Adjustment: Yes |
22.82 [4.25;424.20] excluded (exposition period) |
12/69 1/98 | 13 | 69 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9329 R32533 |
Viinikainen (Valproate) (Controls unexposed, sick) a, 2006 | Major malformations | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 5.83 [0.23;148.09] C | 1/28 0/52 | 1 | 28 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9330 R32534 |
Artama (Valproate), 2005 | Malformations | 1st trimester | retrospective cohort (registry) | unexposed, sick | Adjustment: No | 4.18 [2.31;7.57] | 28/263 26/939 | 54 | 263 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9300 R32383 |
Endo (Valproate) (Controls unexposed, disease free), 2004 | Congenital malformations | at least 1st trimester | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
2.54 [0.13;48.35] C excluded (control group) |
0/5 27/656 | 27 | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9301 R32398 |
Endo (Valproate) (Controls unexposed, sick), 2004 | Congenital malformations | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.11 [0.00;14.76] C | 0/5 0/1 | 0 | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9342 R32591 |
Kaaja (Valproate), 2003 | Major malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 8.32 [1.49;46.53] C | 4/61 2/239 | 6 | 61 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9299 R32370 |
Dean (Valproate), 2002 | Congenital malformations (major and minor) | at least 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 7.82 [2.84;21.53] C | 30/47 7/38 | 37 | 47 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9306 R32414 |
Hvas (Valproate) (Controls unexposed, disease free), 2000 | Major congenital malformations | 1st trimester | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
16.82 [3.67;77.12] C excluded (control group) |
2/12 280/23,827 | 282 | 12 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9307 R32416 |
Hvas (Valproate) (Controls unexposed, sick), 2000 | Major congenital malformations | 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 55.53 [2.48;1242.66] C | 2/12 0/106 | 2 | 12 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9279 R32188 |
Al Bunyan (Valproate), 1999 | Congenital malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
2.11 [0.04;124.53] C excluded (exposition period) |
0/5 0/10 | 0 | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9335 R32579 |
Canger (Valproate), 1999 | All type of malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 11.73 [0.65;212.86] C | 8/44 0/25 | 8 | 44 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9344 R32593 |
Kaneko (Valproate), 1999 | Malformations | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 3.96 [1.03;15.15] C | 9/81 3/98 | 12 | 81 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9353 R32724 |
Samrén (Valproate), 1999 | Major congential abnormalities | at least 1st trimester | retrospective cohort | unexposed, disease free | Adjustment: No Matched | 4.10 [1.90;8.80] | 9/158 29/2,000 | 38 | 158 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9354 R32726 |
Steegers-Theunissen (Valproate), 1994 | Major malformations (ICD9 British Paediatric Association System) | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, disease free | Adjustment: No |
9.75 [1.51;62.95] C excluded (exposition period) |
3/19 2/106 | 5 | 19 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9297 R32297 |
D'Souza (Valproate) (Controls unexposed, disease free), 1991 | Congenital anomalies | throughout pregnancy | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
123.00 [1.00;15058.31] C excluded (control group) |
0/1 0/62 | 0 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9298 R32326 |
D'Souza (Valproate) (Controls unexposed, sick), 1991 | Congenital anomalies | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 4.33 [0.06;320.42] C | 0/1 1/8 | 1 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9308 R32423 |
Jäger-Roman (Valproate), 1986 | Major malformations | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No | 6.23 [1.55;24.98] C | 4/14 7/116 | 11 | 14 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9352 R32722 |
Robert (Valproate), 1986 | Congenital malformations (minor and major) | 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 3.88 [0.87;17.29] C | 5/15 4/35 | 9 | 15 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 33 studies | 3.16 [2.64;3.78] | 198,716 | 8,172 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Valproate) (Mixed indications) (Controls unexposed, NOS; 2: Controls unexposed, disease free) (Indications NOS; 3: Valproate) (Controls unexposed, sick; 4: Valproate) (Controls unexposed, sick; 5: Valproate) (Controls unexposed, sick; 6: Valproate; 7: Valproate; 8: Valproate) (Controls unexposed, sick; 9: Valproate; 10: Valproate) (Controls unexposed, sick; 11: Valproate) (Controls unexposed, sick; 12: Valproate) (Controls unexposed, sick; 13: Valproate) (Controls unexposed, sick) (Mixed indications; 14: Valproate) (Controls unexposed, disease free) (Mixed indications; 15: Valproate) (Controls unexposed, NOS) (Indications NOS; 16: Valproate) (Controls unexposed, NOS) (Mixed indications; 17: Valproate; 18: Valproate; 19: Valproate) (Controls unexposed, sick; 20: Valproate) (Controls unexposed, sick; 21: Valproate) (Mixed indications; 22: Valproate) (Controls unexposed, sick) ; 23: Valproate; 24: Valproate) (Controls unexposed, sick; 25: Valproate; 26: Valproate; 27: Valproate) (Controls unexposed, sick; 28: Valproate; 29: Valproate; 30: Valproate; 31: Valproate) (Controls unexposed, sick; 32: Valproate; 33: Valproate;
Asymetry test p-value = 0.0041 (by Egger's regression)
slope=0.9529 (0.0879); intercept=0.5270 (0.2992); t=1.7613; p=0.0041
excluded 9297, 9306, 9300, 9290, 9312, 9317, 9293, 9336, 9309, 9450, 9333, 9325, 9326, 9362, 10210, 10211, 9452, 9360, 9280, 9287, 12689, 12882, 12862, 12863, 9304, 15200, 15264, 15216