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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S15827 R65177 |
Cohen (Oxcarbazepine) (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 |
1.09 [0.83;1.44] excluded (control group) |
58/1,313 314/8,339 | 372 | 1,313 |
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S15828 R65179 |
Cohen (Oxcarbazepine) (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 | 1.47 [1.13;1.92] C | 58/1,313 147,928/4,866,362 | 147,986 | 1,313 |
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S15856 R65268 |
Li (Oxcarbazepine) (Controls exposed to LTG), 2023 | Major congenital malformation | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
4.52 [0.21;97.17] C excluded (control group) |
2/44 0/38 | 2 | 44 |
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S15857 R65270 |
Li (Oxcarbazepine) (Controls unexposed, sick), 2023 | Major congenital malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
1.67 [0.34;8.33] C excluded (exposition period) |
2/44 7/253 | 9 | 44 |
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S12888 R48701 |
Hosny (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2021 | Major birth defects | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.20 [0.00;28.47] C excluded (control group) |
0/3 0/1 | 0 | 3 |
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S12889 R48704 |
Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021 | Major birth defects | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 2.60 [0.08;82.80] C | 0/3 1/21 | 1 | 3 |
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S12828 R48297 |
Thomas (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
3.71 [0.42;32.79] C excluded (control group) |
5/71 1/50 | 6 | 71 |
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S7548 R22591 |
Thomas (Oxcarbazepine) (Controls unexposed, disease free), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
2.12 [0.62;7.29] excluded (control group) |
3/41 11/319 | 14 | 41 |
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S12830 R48309 |
Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: Yes | 1.61 [0.60;4.20] | 5/71 16/340 | 21 | 71 |
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S7959 R24145 |
AlSheikh (Oxcarbazepine) (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 |
7.80 [0.12;487.53] C excluded (control group) |
0/3 0/20 | 0 | 3 |
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S7957 R24117 |
AlSheikh (Oxcarbazepine) (Controls unexposed, sick), 2020 | Fetal/neonatal malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
0.87 [0.03;29.20] C excluded (exposition period) |
0/3 1/8 | 1 | 3 |
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S7784 R23002 |
Vajda (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
1.07 [0.14;8.44] C excluded (control group) |
1/19 20/406 | 21 | 19 |
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S7785 R23003 |
Vajda (Oxcarbazepine) (Controls unexposed, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 1.85 [0.23;15.04] | 1/19 5/176 | 6 | 19 |
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S7659 R22649 |
Tomson (Oxcarbazepine) , 2018 | Major congenital malformation | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 1.02 [0.52;2.00] C | 10/333 74/2,514 | 84 | 333 |
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S10271 R37614 |
Razaz (Oxcarbazepine) (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 |
0.99 [0.13;7.71] C excluded (control group) |
1/23 22/503 | 23 | 23 |
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S10270 R37613 |
Razaz (Oxcarbazepine) (Controls unexposed, disease free), 2017 | Major malformations | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, disease free excluded | Adjustment: No |
1.34 [0.18;9.96] C excluded (control group) |
1/23 46,632/1,424,279 | 46,633 | 23 |
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S10272 R37615 |
Razaz (Oxcarbazepine) (Controls unexposed, sick), 2017 | Major malformations | during pregnancy (anytime or not specified) excluded | population based cohort retrospective | unexposed, sick | Adjustment: No |
0.93 [0.12;6.98] C excluded (exposition period) |
1/23 87/1,868 | 88 | 23 |
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S6333 R17155 |
Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No Partial overlapping |
0.50 [0.07;3.75] C excluded (control group) |
1/51 23/593 | 24 | 51 |
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S6334 R17156 |
Veiby (Oxcarbazepine) (Controls unexposed, disease free), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes Partial overlapping |
0.72 [0.10;5.18] excluded (control group) |
1/51 22,371/771,412 | 22,372 | 51 |
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S6335 R17157 |
Veiby (Oxcarbazepine) (Controls unexposed, sick), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No Partial overlapping | 0.69 [0.09;5.06] C | 1/51 106/3,773 | 107 | 51 |
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S5942 R15204 |
Hernández-Díaz (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2012 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No Controls: mixed indications |
1.50 [0.50;4.60] excluded (control group) |
-/- -/- | - | - |
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S7937 R24013 |
Hernández-Díaz (Oxcarbazepine) (Controls unexposed, disease free), 2012 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 2.00 [0.50;7.40] | 4/182 5/442 | 9 | 182 |
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S6650 R18356 |
Kini (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2007 | Major malformations | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
29.00 [0.23;3625.72] C excluded (control group) |
0/1 0/15 | 0 | 1 |
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S6640 R18346 |
Kini (Oxcarbazepine) (Controls unexposed, disease free), 2007 | Major malformations | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
41.91 [0.76;2311.57] C excluded (control group) |
0/1 5/236 | 5 | 1 |
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S6645 R18351 |
Kini (Oxcarbazepine) (Controls unexposed, sick), 2007 | Major malformations | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
67.00 [0.54;8247.13] C excluded (exposition period) |
0/1 0/34 | 0 | 1 |
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S6071 R15798 |
Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 | Major congenital malformation | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.24 [0.12;41.02] C excluded (control group) |
0/7 21/647 | 21 | 7 |
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S6072 R15805 |
Morrow (Oxcarbazepine) (Controls unexposed, sick), 2006 | Major congenital malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 1.98 [0.10;38.04] C | 0/7 8/227 | 8 | 7 |
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S6170 R16235 |
Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 | Major malformations | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 34.33 [0.49;2389.88] C | 0/2 0/52 | 0 | 2 |
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S6141 R16035 |
Kaaja (Oxcarbazepine), 2003 | Major malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: Yes | 10.80 [1.10;106.20] | 1/9 2/239 | 3 | 9 |
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S6928 R19481 |
Hvas (Oxcarbazepine) (Controls unexposed, disease free), 2000 | Major congenital malformations | 1st trimester | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
6.46 [0.36;114.91] C excluded (control group) |
0/7 280/23,827 | 280 | 7 |
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S6924 R19477 |
Hvas (Oxcarbazepine) (Controls unexposed, sick), 2000 | Major congenital malformations | 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 16.23 [0.30;885.49] C | 0/7 0/106 | 0 | 7 |
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S6716 R18989 |
Samrén (Oxcarbazepine), 1999 | Major congential abnormalities | at least 1st trimester | retrospective cohort | unexposed, disease free | Adjustment: No Matched | 22.27 [0.89;557.96] C | 0/2 29/2,000 | 29 | 2 |
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Total | 12 studies | 1.51 [1.17;1.96] | 148,254 | 1,999 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Oxcarbazepine) (Epilepsy) (Controls unexposed, NOS; 2: Oxcarbazepine) (Controls unexposed, sick; 3: Oxcarbazepine) (Controls unexposed, sick; 4: Oxcarbazepine) (Controls unexposed, sick; 5: Oxcarbazepine; 6: Oxcarbazepine) (Controls unexposed, sick; 7: Oxcarbazepine) (Controls unexposed, disease free; 8: Oxcarbazepine) (Controls unexposed, sick; 9: Oxcarbazepine) (Controls unexposed, sick) ; 10: Oxcarbazepine; 11: Oxcarbazepine) (Controls unexposed, sick; 12: Oxcarbazepine;
Asymetry test p-value = 0.0456 (by Egger's regression)
slope=0.2117 (0.1312); intercept=0.7454 (0.3266); t=2.2823; p=0.0456
excluded 6928, 6071, 6650, 6640, 5942, 6333, 6334, 10271, 10270, 7784, 7959, 12888, 12828, 7548, 15827, 15856