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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S15202 R62356 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15203 R62357 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S15261 R62746 |
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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S15262 R62747 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9046 R30883 |
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 |
0.87 [0.34;2.21] C excluded (control group) |
5/304 44/2,333 | 49 | 304 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9047 R30885 |
The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 1.66 [0.58;4.74] C | 5/304 12/1,201 | 17 | 304 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12890 R48707 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12891 R48710 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12831 R48319 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12832 R48327 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12833 R48331 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9034 R30796 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9035 R30799 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9075 R31070 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9076 R31071 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9074 R31060 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9042 R30870 |
Bank (Oxcarbazepine) (Mixed indications), 2017 | Major Malformation | during pregnancy (anytime or not specified) excluded | prospective cohort | exposed to other treatment, sick | Adjustment: No |
10.14 [0.17;594.47] C excluded (exposition period) |
0/4 0/36 | 0 | 4 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9052 R30897 |
Veiby (Oxcarbazepine) (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 |
0.51 [0.07;3.84] C excluded (control group) |
1/57 28/833 | 29 | 57 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9053 R30899 |
Veiby (Oxcarbazepine) (Controls unexposed, disease free) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes Partial overlapping |
0.64 [0.10;4.61] excluded (control group) |
1/57 22,371/771,412 | 22,372 | 57 |
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S9054 R30901 |
Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication Partial overlapping | 0.62 [0.08;4.50] C | 1/57 106/3,773 | 107 | 57 |
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S9050 R30891 |
Källén (Oxcarbazepine) (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 |
3.14 [1.06;9.29] C excluded (control group) |
4/40 37/1,084 | 41 | 40 |
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S9051 R30893 |
Källén (Oxcarbazepine) (Controls unexposed, NOS) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes Partial overlapping | 2.27 [0.62;5.82] | 4/40 49,499/1,575,847 | 49,503 | 40 |
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S9059 R30927 |
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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S9060 R30929 |
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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S9061 R30931 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9062 R30933 |
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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S9063 R30941 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9065 R30944 |
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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S9058 R30925 |
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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S9048 R30887 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9049 R30889 |
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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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9070 R31052 |
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 | 13 studies | 1.52 [1.22;1.89] | 197,765 | 2,167 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Controls unexposed, disease free) (Indications NOS; 3: Oxcarbazepine) (Controls unexposed, sick; 4: Oxcarbazepine) (Controls unexposed, sick; 5: Oxcarbazepine) (Controls unexposed, sick; 6: Oxcarbazepine; 7: Oxcarbazepine) (Controls unexposed, sick) (Mixed indications; 8: Oxcarbazepine) (Controls unexposed, NOS) (Indications NOS; 9: Oxcarbazepine) (Controls unexposed, sick; 10: Oxcarbazepine) (Controls unexposed, sick) ; 11: Oxcarbazepine; 12: Oxcarbazepine) (Controls unexposed, sick; 13: Oxcarbazepine;
Asymetry test p-value = 0.0380 (by Egger's regression)
slope=0.2129 (0.1288); intercept=0.7474 (0.3170); t=2.3575; p=0.0380
excluded 9048, 9062, 9059, 9060, 9050, 9052, 9053, 9075, 9034, 12890, 12831, 12832, 9046, 15202, 15261