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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S12727 R53704 |
Bjørk (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2022 | Diagnosis of intellectual disability (ID): mild ID (F70), moderate ID (F71), severe ID (F72), and profound ID (F73) (between 6.1 and 7.9 years old) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) excluded | Adjustment: Yes |
1.34 [0.92;1.95] excluded (control group) |
27/7,950 16,384/4,463,879 | 16,411 | 7,950 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12728 R53705 |
Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 | Diagnosis of intellectual disability (ID): mild ID (F70), moderate ID (F71), severe ID (F72), and profound ID (F73) (between 6.1 and 7.9 years old) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication | 0.53 [0.35;0.80] C | 27/7,950 139/21,634 | 166 | 7,950 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8941 R53702 |
Cohen-Israel (Lamotrigine), 2018 | Developmental delay (a majority between 6-12 years old) | 1st trimester | retrospective cohort | unexposed, disease free | Adjustment: No Matched | 0.57 [0.26;1.26] C | 12/83 19/83 | 31 | 83 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8929 R53700 |
Baker (Lamotrigine) (Controls unexposed, disease free), 2015 | Mean child Full scale IQ - Differential ability scales (DAS) (age mean >6 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: No extrapolated (cont. endpoint) |
1.84 [0.91;3.72] excluded (control group) |
-/29 -/210 | - | 29 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8930 R53701 |
Baker (Lamotrigine) (Controls unexposed, sick), 2015 | Mean child Full scale IQ - Differential ability scales (DAS) (age mean >6 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) | 1.16 [0.44;3.07] | -/29 -/25 | - | 29 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8945 R53703 |
Gopinath (Lamotrigine), 2015 | Full Scale IQ < 86 (Wechsler Intelligence Scale for Children (WISC-IV)) (at 10–12 years of age) | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, sick | Adjustment: No | 0.39 [0.01;22.88] C | 0/1 11/16 | 11 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 4 studies | 0.59 [0.42;0.83] | 208 | 8,063 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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) (Controls unexposed, sick) (Mixed indications; 2: Lamotrigine; 3: Lamotrigine) (Controls unexposed, sick; 4: Lamotrigine;
Asymetry test p-value = NaN (by Egger's regression)
not enought points
excluded 8929, 12727