| 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S12708 R47949 |
Bjørk (Valproate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2022 | Neurodevelopmental Disorder (ND): any diagnoses of autism spectrum disorder (F84.0, F84.1, F84.5) or intellectual disability (F70, F71, F72, F73) plus F84.3, F84.4, F84.8, F84.9, F79 (between 6.1 and 7.9 years old) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
5.01 [3.99;6.28] C excluded (control group) |
190/2,421 133/7,950 | 323 | 2,421 |
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| S12519 R47943 |
Bjørk (Valproate) (Controls unexposed NOS) (Mixed indications), 2022 | Neurodevelopmental Disorder (ND): any diagnoses of autism spectrum disorder (F84.0, F84.1, F84.5) or intellectual disability (F70, F71, F72, F73) plus F84.3, F84.4, F84.8, F84.9, F79 (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 |
3.87 [3.36;4.47] excluded (control group) |
190/2,421 68,295/4,463,879 | 68,485 | 2,421 |
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| S12707 R47946 |
Bjørk (Valproate) (Controls unexposed, sick) (Mixed indications), 2022 | Neurodevelopmental Disorder (ND): any diagnoses of autism spectrum disorder (F84.0, F84.1, F84.5) or intellectual disability (F70, F71, F72, F73) plus F84.3, F84.4, F84.8, F84.9, F79 (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 | 4.07 [3.42;4.86] C | 190/2,421 443/21,634 | 633 | 2,421 |
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| S9392 R32899 |
Coste (Valproate) (Controls unexposed, NOS), 2020 | Diagnosis Disorders of psychological development (F80–F89) (mean age of 3.6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 4.70 [3.50;6.40] | 41/991 10,010/1,710,441 | 10,051 | 991 |
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| S9384 R32845 |
Charlton (Valproate), 2017 | Neurodevelopmental disorders (at 6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed, disease free | Adjustment: Yes Matched | 2.02 [0.52;7.86] | -/118 58/6,048 | 49 | 118 |
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| S9282 R32200 |
Arkilo (Valproate), 2015 | Abnormal development (At 2 years of age, assessed by developmental specialists) | during pregnancy (anytime or not specified) | retrospective cohort | exposed to other treatment, sick | Adjustment: No | 11.00 [0.48;250.88] C | 1/2 2/24 | 3 | 2 |
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| S9377 R32810 |
Bromley (Valproate) (Controls exposed to Lamotrigine, sick), 2013 | Neurodevelopmental disorder (at 6 years old) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
1.91 [0.36;10.13] C excluded (control group) |
6/50 2/30 | 8 | 50 |
|
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| S9380 R32826 |
Bromley (Valproate) (Controls unexposed, disease free), 2013 | Neurodevelopmental disorder (at 6 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: Yes |
6.05 [1.65;24.53] excluded (control group) |
6/50 4/214 | 10 | 50 |
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| S9383 R32842 |
Bromley (Valproate) (Controls unexposed, sick), 2013 | Neurodevelopmental disorder (at 6 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 7.62 [0.41;140.98] C | 6/50 0/26 | 6 | 50 |
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| S9450 R33195 |
Rihtman (Valproate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2013 | Children: special education (mean age 4-5 years old) | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No Controls: epilepsy indication |
2.93 [0.25;33.87] C excluded (control group) |
2/30 1/42 | 3 | 30 |
|
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| S9451 R33230 |
Rihtman (Valproate) (Controls unexposed, NOS) (Mixed indications), 2013 | Children: special education (mean age 4-5 years old) | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No | 3.64 [0.32;41.98] C | 2/30 1/52 | 3 | 30 |
|
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| S9339 R32585 |
Dean (Valproate) (Controls exposed to Lamotrigine, sick), 2007 | Neurodevelopmental disorder (mean age in years: m1=2.75 and m0=1.5) | during pregnancy (anytime or not specified) | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.38 [0.12;48.80] C excluded (control group) |
15/61 0/4 | 15 | 61 |
|
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| S9340 R32587 |
Dean (Valproate) (Controls unexposed, sick), 2007 | Neurodevelopmental disorder (mean age in years: m1=2.75 and m0=15.25) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 4.67 [1.26;17.28] C | 15/61 3/46 | 18 | 61 |
|
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| S9428 R33109 |
Viinikainen (Valproate) b, 2006 | Need for educational support | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No Matched | 8.80 [1.35;57.43] C | 8/13 2/13 | 10 | 13 |
|
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| S9278 R32178 |
Adab (Valproate), 2004 | Any additional educational needs | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 1.95 [0.95;3.97] | 24/50 28/87 | 52 | 50 |
|
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| S9311 R32440 |
Katz (Valproate), 2001 | Developmental delay (Based on the DSM-IV-TR criteria) | during pregnancy (anytime or not specified) | retrospective cohort | exposed to other treatment, sick | Adjustment: No | 3.00 [0.08;115.35] C | 1/4 0/3 | 1 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 10 studies | 4.09 [3.54;4.73] | 10,826 | 3,740 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) (Controls unexposed, sick) (Mixed indications; 2: Valproate) (Controls unexposed, NOS; 3: Valproate; 4: Valproate; 5: Valproate) (Controls unexposed, sick; 6: Valproate) (Controls unexposed, NOS) (Mixed indications; 7: Valproate) (Controls unexposed, sick; 8: Valproate) ; 9: Valproate; 10: Valproate;
Asymetry test p-value = 0.8653 (by Egger's regression)
slope=1.4185 (0.0912); intercept=-0.0681 (0.3887); t=0.1752; p=0.8653
excluded 9339, 9377, 9380, 9450, 12708, 12519