Lacosamide (All indications)

Major congenital malformations

R analysis
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.
S10247
R37524		 The NAAED (Controls exposed to Lamotrigine, sick) (Indications NOS), 2022 Major congenital malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.40 [0.02;6.65] C
excluded (control group) 		0/64   44/2,333 44 64
ref
S10248
R37526		 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Major congenital malformations 1st trimester prospective cohort unexposed, disease free Adjustment: No 0.75 [0.04;12.79] C 0/64   12/1,201 12 64
ref
S7664
R22694		 Tomson (Lacosamide), 2018 Malformed Offspring at least 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 2.18 [0.12;38.58] C 0/8   74/2,514 74 8
ref
Total 2 studies 1.27 [0.17;9.56] 86 72
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

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF The NAAED (Controls unexposed, disease free) (Indications NOS), 2022The NAAED, 2022 1 0.75[0.04; 12.79]126451%ROB confusion: criticalROB selection: unclearROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: low Tomson (Lacosamide), 2018Tomson, 2018 2 2.18[0.12; 38.58]74849%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (2 studies) I2 = 0% 1.27[0.17; 9.56]86720.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, disease free) (Indications NOS; 2: Lacosamide;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.27[0.17; 9.56]86720%NAThe NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Tomson (Lacosamide), 2018 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.75[0.04; 12.79]1264 -NAThe NAAED (Controls unexposed, disease free) (Indications NOS), 2022 1 exposed to other treatment, sickexposed to other treatment, sick 2.18[0.12; 38.58]748 -NATomson (Lacosamide), 2018 1 Tags Adjustment   - No  - No 1.27[0.17; 9.56]86720%NAThe NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Tomson (Lacosamide), 2018 2 All studiesAll studies 1.27[0.17; 9.56]86720%NAThe NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Tomson (Lacosamide), 2018 20.25.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded 10247

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 0.75[0.04; 12.79]1264 -NAThe NAAED (Controls unexposed, disease free) (Indications NOS), 2022 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.92[0.12; 6.83]118720%NAThe NAAED (Controls exposed to Lamotrigine, sick) (Indications NOS), 2022 Tomson (Lacosamide), 2018 20.510.01.0