| 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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| S15218 R62393 |
Bromley (Lamotrigine) (Epilepsy), 2023 | Small for gestation (calculated using gender-specific scales) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 0.72 [0.31;1.65] C | 13/106 13/80 | 26 | 106 |
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| S12547 R47237 |
Dreier (Lamotrigine), 2021 | Small for gestational age (birth weight below the 10th percentile for GA, sex and country) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 0.97 [0.87;1.08] | -/4,679 -/- | - | 4,679 |
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| S12611 R47524 |
Van Marter (Lamotrigine) (Controls unexposed, disease free), 2021 | Small for gestational age (weight for gestational age <10th percentile) | at least 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
0.10 [0.01;0.79] C excluded (control group) |
1/106 9/102 | 10 | 106 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S12613 R47536 |
Van Marter (Lamotrigine) (Controls unexposed, sick), 2021 | Small for gestational age (weight for gestational age <10th percentile) | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.39 [0.02;10.00] C | 1/106 0/14 | 1 | 106 |
|
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| S8904 R30081 |
Aydin (Lamotrigine), 2020 | Small for gestational age (birth weight) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 3.31 [0.06;183.69] C | 0/7 0/22 | 0 | 7 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8978 R30434 |
Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 1.04 [0.92;1.17] C | 284/2,813 167,016/1,707,707 | 167,300 | 2,813 |
|
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| S8963 R30354 |
Cohen (Lamotrigine) (Mixed indications), 2019 | Small for gestational age (ICD-9 656.5, 764.0, 764.1, 764.9) | early pregnancy | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 0.86 [0.69;1.05] | 106/2,682 41,653/1,440,631 | 41,759 | 2,682 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8974 R30419 |
Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 | Small for gestational age (SGA) (<10th percentile) | throughout pregnancy | prospective cohort | unexposed, disease free | Adjustment: No | 1.37 [0.86;2.18] C | 107/1,581 23/457 | 130 | 1,581 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8975 R30421 |
Kilic (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2014 | Small for gestational age (birth weight <10% percentile for the gestational birth week) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) excluded | Adjustment: Yes |
0.80 [0.70;1.10] excluded (control group) |
78/876 65,118/673,844 | 65,196 | 876 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8976 R30424 |
Kilic (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 | Small for gestational age (birth weight <10% percentile for the gestational birth week) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication | 0.77 [0.60;0.99] C | 78/876 594/5,275 | 672 | 876 |
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| S8902 R30064 |
Artama (Lamotrigine) (Controls unexposed, disease free), 2013 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes |
0.49 [0.12;1.97] excluded (control group) |
2/173 14,079/719,509 | 14,081 | 173 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8903 R30076 |
Artama (Lamotrigine) (Controls unexposed, sick), 2013 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 0.42 [0.10;1.81] | 2/173 42/1,793 | 44 | 173 |
|
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| S8953 R30313 |
Veiby (Lamotrigine) (Controls unexposed, disease free) b, 2013 | Small for gestational age (SGA) birth weight | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: Yes |
0.60 [0.20;1.40] excluded (control group) |
5/103 8,017/106,899 | 8,022 | 103 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8954 R30327 |
Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 | Small for gestational age (SGA) birth weight | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 0.58 [0.22;1.54] C | 5/103 31/386 | 36 | 103 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 10 studies | 0.94 [0.86;1.04] | 209,968 | 13,126 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Lamotrigine) (Epilepsy; 2: Lamotrigine; 3: Lamotrigine) (Controls unexposed, sick; 4: Lamotrigine; 5: Lamotrigine) (Controls unexposed NOS) (Mixed indications; 6: Lamotrigine) (Mixed indications; 7: Lamotrigine) (Mixed indications; 8: Lamotrigine) (Controls unexposed, sick) (Mixed indications; 9: Lamotrigine) (Controls unexposed, sick; 10: Lamotrigine) (Controls unexposed, sick) ;
Asymetry test p-value = 0.3101 (by Egger's regression)
slope=0.0043 (0.0573); intercept=-0.5420 (0.5002); t=1.0836; p=0.3101
excluded 8902, 8953, 8975, 12611