| 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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| S19355 R82456 |
Karayagmurlu (Controls exposed to LTG) (Levetiracetam) (Epilepsy), 2026 | Autism Spectrum Disorder - DSM-5 clinical evaluation conducted by an experienced child and adolescent psychiatrist - Aged 2–6 years | during pregnancy (anytime or not specified) | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
33.00 [0.44;2470.77] C excluded (control group) |
1/2 0/6 | 1 | 2 |
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| S19356 R82460 |
Karayagmurlu (Controls unexposed, disease free) (Levetiracetam) (Epilepsy), 2026 | Autism Spectrum Disorder - DSM-5 clinical evaluation conducted by an experienced child and adolescent psychiatrist - Aged 2–6 years | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
315.00 [4.53;21922.94] C excluded (control group) |
1/2 0/53 | 1 | 2 |
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| S19357 R82464 |
Karayagmurlu (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026 | Autism Spectrum Disorder - DSM-5 clinical evaluation conducted by an experienced child and adolescent psychiatrist - Aged 2–6 years | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 111.00 [1.57;7848.40] C | 1/2 0/19 | 1 | 2 |
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| S19378 R82467 |
Straub (Controls exposed to LTG) (Levetiracetam) (Epilepsy), 2026 | Autism spectrum disorder - ICD-10 codes: F84.x (except F84.2, F84.3) - Mean follow up (full cohort): 3.4 years | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
0.56 [0.33;0.95] C excluded (control group) |
23/3,929 34/3,273 | 57 | 3,929 |
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| S19369 R82472 |
Straub (Controls unexposed, sick) (Levetiracetam) (Epilepsy), 2026 | Autism spectrum disorder - ICD-10 codes: F84.x (except F84.2, F84.3) - Mean follow up (full cohort): 3.4 years | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes | 0.56 [0.35;0.92] | 23/3,929 106/8,887 | 129 | 3,929 |
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| S17414 R73084 |
Madley-Dowd_SE (Levetiracetam) (Controls exposed to LTG) (Mixed indications), 2024 | Autism - ICD-8/9/10 codes - Mean 5-20 years old (according groups) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: Yes Partial overlapping |
0.97 [0.47;1.99] excluded (control group) |
8/613 134/5,035 | 142 | 613 |
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| S17415 R73085 |
Madley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 | Autism - ICD-8/9/10 codes - Mean 5-20 years old (according groups) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes Partial overlapping | 0.80 [0.40;1.62] | 8/613 68,788/2,651,210 | 68,796 | 613 |
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| S17416 R73086 |
Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sibling) (Mixed indications), 2024 | Autism - ICD-8/9/10 codes - Mean 5-20 years old (according groups) | during pregnancy (anytime or not specified) | population based cohort retrospective | sibling excluded | Adjustment: Yes Partial overlapping |
0.50 [0.10;2.62] excluded (control group) |
-/- -/- | - | - |
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| S17282 R72389 |
Madley-Dowd_UK (Levetiracetam) (Controls exposed to LTG) (Mixed indications), 2024 | Autism - ICD10 codes - Median 4.19 (2.56-6.79) years old | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: Yes |
0.82 [0.20;3.34] excluded (control group) |
-/193 20/939 | - | 193 |
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| S17267 R72390 |
Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 | Autism - ICD10 codes - Median 4.19 (2.56-6.79) years old | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 0.90 [0.22;3.67] | -/193 7,657/514,066 | - | 193 |
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| S17275 R72391 |
Madley-Dowd_UK (Levetiracetam) (Controls unexposed, sibling) (Mixed indications), 2024 | Autism - ICD10 codes - Median 4.19 (2.56-6.79) years old | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | sibling excluded | Adjustment: Yes |
0.59 [0.12;3.01] excluded (control group) |
-/- -/- | - | - |
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| S12775 R48762 |
Bjørk (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2022 | Diagnosis of childhood autism (F84.0), atypical autism (F84.1), and Asperger syndrome (F84.5) - Median follow up levetiracetam 3.6 (1.8-6.5) years old | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
0.71 [0.32;1.57] C excluded (control group) |
7/1,017 49/5,073 | 56 | 1,017 |
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| S12776 R48763 |
Bjørk (Levetiracetam) (Controls unexposed NOS), 2022 | Diagnosis of childhood autism (F84.0), atypical autism (F84.1), and Asperger syndrome (F84.5) - Median follow up levetiracetam 3.6 (1.8-6.5) years old | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) excluded | Adjustment: Yes |
1.59 [0.76;3.33] excluded (control group) |
7/1,017 38,437/4,463,879 | 38,444 | 1,017 |
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| S12777 R48764 |
Bjørk (Levetiracetam) (Controls unexposed, sick), 2022 | Diagnosis of childhood autism (F84.0), atypical autism (F84.1), and Asperger syndrome (F84.5) - Median follow up levetiracetam 3.6 (1.8-6.5) years old | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 1.06 [0.49;2.30] | 7/1,004 267/21,634 | 274 | 1,004 |
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| S10071 R46403 |
Coste (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020 | Diagnosis Pervasive developmental disorders (F84) (mean age of 3.7 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: Yes |
1.80 [0.50;6.60] excluded (control group) |
4/621 7/2,108 | 11 | 621 |
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| S9020 R46404 |
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 | Diagnosis Pervasive developmental disorders (F84) (mean age of 3.6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 2.50 [0.90;6.60] | 4/621 4,280/1,710,441 | 4,284 | 621 |
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| S9022 R46406 |
Huber-Mollema (Levetiracetam), 2019 | Diagnosis of autism spectrum disorder | throughout pregnancy | prospective cohort | exposed to other treatment, sick | Adjustment: No | 0.72 [0.08;6.75] C | 1/30 4/88 | 5 | 30 |
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| S9962 R46407 |
Bjørk (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2018 | Autistic traits at 18 months and/or at 36 months (M-CHAT <2/6 critical or <3/23 or SCQ >13) | during pregnancy (anytime or not specified) | population based cohort propective | exposed to other treatment, sick excluded | Adjustment: No |
2.42 [0.63;9.26] C excluded (control group) |
4/12 13/76 | 17 | 12 |
|
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| S9932 R46408 |
Bjørk (Levetiracetam) (Controls unexposed, disease free), 2018 | Autistic traits at 18 months and/or at 36 months (M-CHAT <2/6 critical or <3/23 or SCQ >13) | during pregnancy (anytime or not specified) | population based cohort propective | unexposed, disease free excluded | Adjustment: No |
4.97 [1.49;16.49] C excluded (control group) |
4/12 6,907/75,497 | 6,911 | 12 |
|
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| S9958 R46409 |
Bjørk (Levetiracetam) (Controls unexposed, sick), 2018 | Autistic traits at 18 months and/or at 36 months (M-CHAT <2/6 critical or <3/23 or SCQ >13) | during pregnancy (anytime or not specified) | population based cohort propective | unexposed, sick | Adjustment: No | 4.54 [1.28;16.06] C | 4/12 27/272 | 31 | 12 |
|
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| Total | 8 studies | 1.25 [0.68;2.29] | 73,520 | 6,404 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Controls unexposed, sick) (Levetiracetam) (Epilepsy; 2: Controls unexposed, sick) (Levetiracetam) (Epilepsy; 3: Levetiracetam) (Controls unexposed, general pop) (Mixed indications; 4: Levetiracetam) (Controls unexposed, general pop) (Mixed indications; 5: Levetiracetam) (Controls unexposed, sick; 6: Levetiracetam) (Controls unexposed, NOS; 7: Levetiracetam; 8: Levetiracetam) (Controls unexposed, sick;
Asymetry test p-value = 0.0451 (by Egger's regression)
slope=-0.9810 (0.4080); intercept=2.3001 (0.9115); t=2.5233; p=0.0451
excluded 9962, 9932, 10071, 12775, 12776, 17414, 17416, 17282, 17275, 19355, 19356, 19378