| 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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| S12749 R48105 |
Bjørk (Carbamazepine) (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 |
1.84 [1.42;2.40] C excluded (control group) |
99/3,256 133/7,950 | 232 | 3,256 |
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| S12748 R48102 |
Bjørk (Carbamazepine) (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 |
1.59 [1.30;1.93] excluded (control group) |
99/3,256 68,295/4,463,879 | 68,394 | 3,256 |
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| S12747 R48099 |
Bjørk (Carbamazepine) (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 | 1.50 [1.20;1.87] C | 99/3,256 443/21,634 | 542 | 3,256 |
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| S9777 R34983 |
Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 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 | 2.00 [1.00;4.10] | 8/468 9,949/1,707,707 | 9,957 | 468 |
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| S9703 R34542 |
Charlton (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2017 | Neurodevelopmental disorders (at 6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
9.38 [0.51;171.34] C excluded (control group) |
5/148 0/122 | 5 | 148 |
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| S9704 R34543 |
Charlton (Carbamazepine) (Controls unexposed, disease free), 2017 | Neurodevelopmental disorders (at 6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed, disease free excluded | Adjustment: Yes Matched |
2.75 [0.92;8.24] excluded (control group) |
5/148 58/6,048 | 63 | 148 |
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| S9705 R34544 |
Charlton (Carbamazepine) (Controls unexposed, sick), 2017 | Neurodevelopmental disorders (at 6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed, sick | Adjustment: No | 1.80 [0.59;5.45] C | 5/148 9/472 | 14 | 148 |
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| S9597 R33989 |
Arkilo (Carbamazepine), 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 | 2.73 [0.39;18.88] C | 3/14 2/22 | 5 | 14 |
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| S9696 R34507 |
Bromley (Carbamazepine) (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 |
0.29 [0.02;3.29] C excluded (control group) |
1/50 2/30 | 3 | 50 |
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| S9699 R34523 |
Bromley (Carbamazepine) (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 |
1.09 [0.06;7.39] excluded (control group) |
1/50 4/214 | 5 | 50 |
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| S9702 R34539 |
Bromley (Carbamazepine) (Controls unexposed, sick), 2013 | Neurodevelopmental disorder (at 6 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 1.58 [0.06;40.13] C | 1/50 0/26 | 1 | 50 |
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| S9660 R34392 |
Dean (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2007 | Neurodevelopmental disorder (mean age in years: m1=5.08 and m0=1.5) | during pregnancy (anytime or not specified) | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.06 [0.10;41.80] C excluded (control group) |
17/77 0/4 | 17 | 77 |
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| S9661 R34394 |
Dean (Carbamazepine) (Controls unexposed, sick), 2007 | Neurodevelopmental disorder (mean age in years: m1=5.08 and m0=15.25) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 4.06 [1.12;14.73] C | 17/77 3/46 | 20 | 77 |
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| S9747 R34801 |
Viinikainen (Carbamazepine) b, 2006 | Need for educational support | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 1.00 [0.12;8.42] C | 2/13 2/13 | 4 | 13 |
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| S9593 R33971 |
Adab (Carbamazepine), 2004 | Any additional educational needs | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 0.63 [0.30;1.33] | 14/61 28/87 | 42 | 61 |
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| S9627 R34239 |
Katz (Carbamazepine), 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 | 1.36 [0.06;33.80] C | 4/21 0/3 | 4 | 21 |
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| S9740 R34704 |
Van der Pol (Carbamazepine) (Controls unexposed, disease free), 1991 | Nonoptimal school career | throughout pregnancy | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
0.22 [0.01;4.05] C excluded (control group) |
0/10 10/54 | 10 | 10 |
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| S9741 R34729 |
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 | Nonoptimal school career | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 0.16 [0.01;3.18] C | 0/10 5/22 | 5 | 10 |
|
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| Total | 10 studies | 1.46 [1.05;2.03] | 10,594 | 4,118 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Carbamazepine) (Controls unexposed, sick) (Mixed indications; 2: Carbamazepine) (Controls unexposed, NOS) (Mixed indications; 3: Carbamazepine) (Controls unexposed, sick; 4: Carbamazepine; 5: Carbamazepine) (Controls unexposed, sick; 6: Carbamazepine) (Controls unexposed, sick; 7: Carbamazepine) ; 8: Carbamazepine; 9: Carbamazepine; 10: Carbamazepine) (Controls unexposed, sick;
Asymetry test p-value = 0.8395 (by Egger's regression)
slope=0.4113 (0.1554); intercept=-0.1037 (0.4957); t=0.2092; p=0.8395
excluded 9740, 9660, 9696, 9699, 9703, 9704, 12749, 12748