| 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S16069 R66687 |
Christensen (Oxcarbazepine) (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: No |
1.05 [0.77;1.41] C excluded (control group) |
52/1,591 274/8,756 | 326 | 1,591 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S16028 R66535 |
Christensen (Oxcarbazepine) (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 | 1.02 [0.75;1.39] | 52/1,591 134,023/4,467,848 | 134,075 | 1,591 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S10171 R37133 |
Blotière (Oxcarbazepine) (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 |
7.21 [0.29;177.79] C excluded (control group) |
0/139 1/2,997 | 1 | 139 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S10039 R36241 |
Blotière (Oxcarbazepine) (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 | 15.44 [0.96;248.47] C | 0/139 438/1,875,733 | 438 | 139 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 2 studies | 2.75 [0.21;35.80] | 134,513 | 1,730 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Oxcarbazepine) (All indications) (Controls unexposed, general population; 2: Oxcarbazepine) (Controls unexposed NOS) (Mixed indications;
Funnel plot not drawn. Less than 3 points.
Asymetry test p-value = NaN (by Egger's regression)
not enought points
Funnel plot not drawn. Less than 3 points.
excluded 10171, 16069