| 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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| S16066 R66675 |
Christensen (Carbamazepine) (All indications) (Controls exposed to LTG), 2024 | Microcephaly (z-score for head circumference ≤3rd percentile for gestational week, sex, and country (including newborns with congenital malformations)) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: Yes |
1.78 [1.36;2.32] excluded (control group) |
135/3,424 274/8,756 | 409 | 3,424 |
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| S16019 R66500 |
Christensen (Carbamazepine) (All indications) (Controls unexposed, general population), 2024 | Microcephaly (z-score for head circumference ≤3rd percentile for gestational week, sex, and country (including newborns with congenital malformations)) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes | 1.43 [1.17;1.75] | 135/3,424 134,023/4,467,848 | 134,158 | 3,424 |
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| S10176 R37249 |
Blotière (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | Microcephaly (until 24 months of age, identifiable by: Q02; brain MRI; according to the EUROCAT definition) | 1st trimester | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
5.86 [0.37;93.89] C excluded (control group) |
1/512 1/2,997 | 2 | 512 |
|
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| S9766 R34899 |
Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 | Microcephaly (until 24 months of age, identifiable by: Q02; brain MRI; according to the EUROCAT definition) | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 7.80 [0.20;44.10] | 1/512 438/1,875,733 | 439 | 512 |
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| S18016 R75958 |
Margulis (Carbamazepine) (Mixed indications), 2019 | Microcephaly (a head circumference of two or more SDs below the mean for gestational age at birth, using a local standard) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick | Adjustment: Yes | 1.20 [0.70;2.00] | -/1,728 -/1,767 | - | 1,728 |
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| S9640 R34296 |
Pennell (Carbamazepine), 2012 | Microcephaly at birth (head circumference < 3 percentile) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 2.51 [0.90;7.05] C | 13/69 6/71 | 19 | 69 |
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| S9669 R34424 |
Kini (Carbamazepine) (Controls unexposed, sick), 2006 | Head circumference in children aged between 6 months and 16 years <3rd centile | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 0.42 [0.08;2.21] C | 2/94 5/101 | 7 | 94 |
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| S9621 R34202 |
Holmes (Carbamazepine) (Controls unexposed, disease free), 2001 | Microcephaly at birth (Head circumference more than 2 SD below the mean value for the same race, sex and gestational age) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
2.31 [0.48;11.18] C excluded (control group) |
2/56 8/508 | 10 | 56 |
|
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| S9622 R34211 |
Holmes (Carbamazepine) (Controls unexposed, sick), 2001 | Microcephaly at birth (Head circumference more than 2 SD below the mean value for the same race, sex and gestational age) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 1.74 [0.24;12.71] C | 2/56 2/96 | 4 | 56 |
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| S9689 R34474 |
Battino (Carbamazepine), 1999 | Small head circumferences (at birth < 10th percentile) | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: Yes | 0.50 [0.11;2.00] | 7/128 3/30 | 10 | 128 |
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| S9690 R34475 |
Díaz-Romero (Carbamazepine), 1999 | Head circumference <2 SD at birth (measured by a physician and correlated with sex and with gestational age) | during pregnancy (anytime or not specified) | cohort | unexposed, sick | Adjustment: No | 0.29 [0.01;16.12] C | 0/26 0/8 | 0 | 26 |
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| S9769 R34930 |
Nulman (Carbamazepine) (Controls unexposed, sick) (Mixed indications), 1997 | Microcephaly at unknown age (head circumference ≤ 2 SD from the mean of children of the same age and sex) | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No Controls: epilepsy indication | 1.95 [0.09;41.57] C | 3/34 0/9 | 3 | 34 |
|
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| Total | 9 studies | 1.39 [1.16;1.67] | 134,640 | 6,071 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) (All indications) (Controls unexposed, general population; 2: Carbamazepine) (Controls unexposed NOS) (Mixed indications; 3: Carbamazepine) (Mixed indications; 4: Carbamazepine; 5: Carbamazepine) (Controls unexposed, sick; 6: Carbamazepine) (Controls unexposed, sick; 7: Carbamazepine; 8: Carbamazepine; 9: Carbamazepine) (Controls unexposed, sick) (Mixed indications;
Asymetry test p-value = 0.6798 (by Egger's regression)
slope=0.3647 (0.1247); intercept=-0.1941 (0.4509); t=0.4305; p=0.6798
excluded 9621, 10176, 16066