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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S9160 R46438 |
Coste (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2020 | Diagnosis Mental retardation (F70–F79) (mean age of 3.6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No Controls: mixed indications |
2.25 [0.29;17.22] C excluded (control group) |
1/84 15/2,813 | 16 | 84 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9161 R46439 |
Coste (Phenobarbital) (Controls unexposed, NOS), 2020 | Diagnosis Mental retardation (F70–F79) (mean age of 3.6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 3.00 [0.40;21.40] | 1/84 3,398/1,710,441 | 3,399 | 84 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9165 R46435 |
Kasradze (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2017 | Full scale IQ (WPPSI-4) (mean age 4-4.5 years old) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No extrapolated (cont. endpoint) |
0.95 [0.05;17.27] excluded (control group) |
-/3 -/3 | - | 3 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9166 R46436 |
Kasradze (Phenobarbital) (Controls unexposed, disease free), 2017 | Full scale IQ (WPPSI-4) (mean age 4-4.5 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free | Adjustment: No extrapolated (cont. endpoint) Matched | 19.35 [2.16;173.39] | -/3 -/50 | - | 3 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9174 R46437 |
Shankaran (Phenobarbital) (Other indications), 1996 | General Cognitive Index (The McCarthy Scales of Children’s Abilities) | days before delivery excluded | randomized controlled trial | unexposed, sick | Adjustment: Randomisation extrapolated (cont. endpoint) |
0.47 [0.22;0.98] excluded (exposition period) |
-/41 -/55 | - | 41 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 2 studies | 7.18 [1.16;44.46] | 3,399 | 87 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Phenobarbital) (Controls unexposed, NOS; 2: Phenobarbital) (Controls unexposed, disease free;
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 9165, 9160