| 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S16071 R66695 |
Christensen (Levetiracetam) (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 |
0.95 [0.65;1.37] C excluded (control group) |
32/1,077 274/8,756 | 306 | 1,077 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S16037 R66568 |
Christensen (Levetiracetam) (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 | 0.89 [0.61;1.30] | 32/1,077 134,023/4,467,848 | 134,055 | 1,077 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S10170 R37110 |
Blotière (Levetiracetam) (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 |
1.73 [0.07;42.42] C excluded (control group) |
0/579 1/2,997 | 1 | 579 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S10037 R36195 |
Blotière (Levetiracetam) (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 | 3.70 [0.23;59.26] C | 0/579 438/1,875,733 | 438 | 579 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 2 studies | 0.91 [0.63;1.33] | 134,493 | 1,656 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Levetiracetam) (All indications) (Controls unexposed, general population; 2: Levetiracetam) (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 10170, 16071