| 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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| S12897 R53309 |
Adams (Carbamazepine), 2022 | Full Scale IQ - The Wechsler Intelligence Scale for Children, 3rd Edition (WISC-III) (mean >6 years old) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) Matched | 2.98 [1.33;6.66] | -/41 -/41 | - | 41 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S12749 R53319 |
Bjørk (Carbamazepine) (Controls exposed to Lamotrigine, 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 | exposed to other treatment, sick excluded | Adjustment: No |
3.28 [1.99;5.41] C excluded (control group) |
36/3,256 27/7,950 | 63 | 3,256 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S12748 R53320 |
Bjørk (Carbamazepine) (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 |
2.01 [1.45;2.79] excluded (control group) |
36/3,256 16,384/4,463,879 | 16,420 | 3,256 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S12747 R53321 |
Bjørk (Carbamazepine) (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 | 1.73 [1.20;2.50] C | 36/3,256 139/21,634 | 175 | 3,256 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S15378 R63362 |
Thomas (Carbamazepine), 2022 | Full-scale IQ - Wechsler Intelligence Scale for Children or Adult - Ages 13 to 21 years (mean of 16.5 ± 2.2 years) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) | 1.85 [0.55;6.31] | -/38 -/11 | - | 38 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9691 R53310 |
Baker (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2015 | Mean child Full scale IQ - Differential ability scales (DAS) (age mean >6 years old) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No extrapolated (cont. endpoint) |
0.77 [0.34;1.77] excluded (control group) |
-/50 -/29 | - | 50 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9692 R53311 |
Baker (Carbamazepine) (Controls unexposed, disease free), 2015 | IQ <85 - Differential ability scales (DAS) (age mean >6 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: Yes |
3.50 [1.10;10.20] excluded (control group) |
-/50 -/210 | - | 50 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9693 R53312 |
Baker (Carbamazepine) (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) | 0.88 [0.37;2.11] | -/50 -/25 | - | 50 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9732 R53316 |
Meador (Carbamazepine), 2013 | IQ <85 (DAS) (at 6 years old) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 3.21 [0.60;17.19] C | 5/61 2/74 | 7 | 61 |
|
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| S9733 R53317 |
Nadebaum (Carbamazepine), 2011 | Full-scale child's IQ (Wechsler Intelligence Scale for Children (WISC)) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No extrapolated (cont. endpoint) | 1.82 [0.48;6.95] | -/34 -/9 | - | 34 |
|
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| S9738 R53324 |
Titze (Carbamazepine) (Controls unexposed, disease free), 2008 | Learning disability (IQ<70) (German versions of the revised Wechsler Intelligence Scales for children and for adults) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
13.86 [0.24;809.27] C excluded (control group) |
0/4 0/49 | 0 | 4 |
|
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| S9739 R53325 |
Titze (Carbamazepine) (Controls unexposed, sick), 2008 | Learning disability (IQ<70) (German versions of the revised Wechsler Intelligence Scales for children and for adults) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 1.10 [0.04;33.38] C | 0/4 1/13 | 1 | 4 |
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| S9747 R53318 |
Viinikainen (Carbamazepine) b, 2006 | Full Scale IQ (FIQ) < 1SD (Wechsler Intelligence Scale for Children (WISC-III)) | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 5.95 [0.26;138.26] C | 2/13 0/13 | 2 | 13 |
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| S9748 R53326 |
Vinten (Carbamazepine), 2005 | IQ score <69 (Wechsler Intelligence Scale for Children (WISC-III)) (Aged between 6 and 16 years) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 1.03 [0.28;3.83] C | 4/52 6/80 | 10 | 52 |
|
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| S9593 R53308 |
Adab (Carbamazepine), 2004 | Mean Full Scale IQ (Wechsler Intelligence Scale for Children (WISC)) (Aged between 6 and 16 years) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) | 0.85 [0.45;1.60] | -/52 -/80 | - | 52 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9720 R53313 |
Gaily (Carbamazepine) (Controls unexposed, disease free), 2004 | Full scale IQ (Wechsler Preschool and Primary Scale of Intelligence Revised (WPPSI-R) or Wechsler Intelligence Scale for Children Revised (WISC-R)) | 2nd and/or 3rd trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No extrapolated (cont. endpoint) |
0.80 [0.49;1.30] excluded (control group) |
-/86 -/140 | - | 86 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9721 R53314 |
Gaily (Carbamazepine) (Controls unexposed, sick), 2004 | Full scale IQ (Wechsler Preschool and Primary Scale of Intelligence Revised (WPPSI-R) or Wechsler Intelligence Scale for Children Revised (WISC-R)) | 2nd and/or 3rd trimester | prospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) | 0.65 [0.34;1.26] | -/86 -/45 | - | 86 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 11 studies | 1.34 [0.94;1.92] | 195 | 3,687 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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; 2: Carbamazepine) (Controls unexposed, sick) (Mixed indications; 3: Carbamazepine; 4: Carbamazepine) (Controls unexposed, sick; 5: Carbamazepine; 6: Carbamazepine; 7: Carbamazepine) (Controls unexposed, sick; 8: Carbamazepine) ; 9: Carbamazepine; 10: Carbamazepine; 11: Carbamazepine) (Controls unexposed, sick;
Asymetry test p-value = 0.7876 (by Egger's regression)
slope=0.2449 (0.3043); intercept=0.2082 (0.7500); t=0.2776; p=0.7876
excluded 9720, 9738, 9691, 9692, 12749, 12748