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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S9391 R46549 |
Coste (Valproate) (Controls exposed to Lamotrigine, sick), 2020 | Diagnosis Mental retardation (F70–F79) (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 |
4.00 [1.90;8.60] excluded (control group) |
15/991 10/2,108 | 25 | 991 |
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S9392 R46550 |
Coste (Valproate) (Controls unexposed, NOS), 2020 | Diagnosis Mental retardation (F70–F79) (mean age of 3.6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 5.10 [3.10;8.50] | 15/991 3,398/1,710,441 | 3,413 | 991 |
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S9408 R46544 |
Kasradze (Valproate) (Controls exposed to Lamotrigine, sick), 2017 | Full scale IQ (WPPSI-4) (mean age 4-4.5 years old) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No extrapolated (cont. endpoint) |
0.40 [0.04;3.75] excluded (control group) |
-/18 -/3 | - | 18 |
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S9409 R46545 |
Kasradze (Valproate) (Controls unexposed, disease free), 2017 | Full scale IQ (WPPSI-4) (mean age 4-4.5 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free | Adjustment: No extrapolated (cont. endpoint) Matched | 11.27 [3.89;32.66] | -/18 -/50 | - | 18 |
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S9398 R46543 |
Deshmukh (Valproate), 2016 | Vineland-II Adaptative Behavior Scales - Low and moderately low in the overall ABC (Adaptative Behavior Composite) | throughout pregnancy | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 9.09 [1.35;50.00] | 10/51 3/104 | 13 | 51 |
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S9414 R46546 |
Meador (Valproate), 2013 | IQ <85 (DAS) (at 4.5 years old) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 2.03 [0.61;6.78] C | 6/39 6/73 | 12 | 39 |
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S9450 R46547 |
Rihtman (Valproate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2013 | Stanford Binet Intelligence Scales, Fifth Edition (SB5) - GIQ (mean age 4-5 years old) | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No Controls: epilepsy indication extrapolated (cont. endpoint) |
1.29 [0.54;3.06] excluded (control group) |
-/29 -/41 | - | 29 |
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S9451 R46548 |
Rihtman (Valproate) (Controls unexposed, NOS) (Mixed indications), 2013 | Stanford Binet Intelligence Scales, Fifth Edition (SB5) - GIQ (mean age 4-5 years old) | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No extrapolated (cont. endpoint) | 2.33 [1.01;5.38] | -/29 -/52 | - | 29 |
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S9394 R46541 |
Cummings (Valproate) (Controls exposed to Lamotrigine, sick), 2011 | Mild or significant delay (score ≥1, <2 SD or ≥2 SD below the mean) (Bayley Scales of Infant Development or the Griffiths Scale) (mean age in years: m1=2.9 and m0=2.7) | throughout pregnancy | retrospective cohort (registry) | exposed to other treatment, sick excluded | Adjustment: No |
22.34 [2.86;174.78] C excluded (control group) |
23/58 1/35 | 24 | 58 |
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S9395 R46542 |
Cummings (Valproate) (Controls unexposed, disease free), 2011 | Mild or significant delay (score ≥1, <2 SD or ≥2 SD below the mean) (Bayley Scales of Infant Development or the Griffiths Scale) (mean age in years: m1=2.9 and m0=4.3) | throughout pregnancy | retrospective cohort (registry) | unexposed, disease free | Adjustment: Yes | 26.10 [4.90;139.00] | 23/58 2/44 | 25 | 58 |
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S9402 R46552 |
Gaily (Valproate) (Controls unexposed, sick), 2004 | Mental retardation (Verbal and nonverbal IQ <70) | 2nd and/or 3rd trimester | prospective cohort | unexposed, sick | Adjustment: No | 1.79 [0.15;21.49] C | 1/13 2/45 | 3 | 13 |
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Total | 7 studies | 5.06 [2.73;9.37] | 3,466 | 1,199 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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, NOS; 2: Valproate) (Controls unexposed, disease free; 3: Valproate; 4: Valproate; 5: Valproate) (Controls unexposed, NOS) (Mixed indications; 6: Valproate) (Controls unexposed, disease free; 7: Valproate) (Controls unexposed, sick;
Asymetry test p-value = 0.7693 (by Egger's regression)
slope=1.4041 (0.6063); intercept=0.3874 (1.2511); t=0.3096; p=0.7693
excluded 9394, 9450, 9408, 9391