Brivaracetam (All indications) updated on 04-22-2025

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.
S16576
R69633		 Battino (Epilepsy), 2024 Major congenital malformations (MCMs) early pregnancy prospective cohort exposed to other treatment, sick Adjustment: No 10.48 [0.42;258.67] C 0/2   110/3,584 110 2
ref
S17166
R71984		 The NAAED (Indications NOS) (Controls exposed to LTG), 2024 Major congenital malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 1.58 [0.09;26.87] C
excluded (control group) 		0/15   52/2,461 52 15
ref
S17165
R71982		 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 Major congenital malformations 1st trimester prospective cohort unexposed, disease free Adjustment: No 2.88 [0.16;50.50] C 0/15   15/1,311 15 15
ref
Total 2 studies 5.11 [0.60;43.25] 125 17
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 Battino (Epilepsy), 2024Battino, 2024 1 10.48[0.42; 258.67]110244%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate The NAAED (Indications NOS) (Controls unexposed, disease free), 2024The NAAED, 2024 2 2.88[0.16; 50.50]151556%ROB confusion: criticalROB selection: unclearROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: low Total (2 studies) I2 = 0% 5.11[0.60; 43.25]125170.950.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

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

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 5.11[0.60; 43.25]125170%NABattino (Epilepsy), 2024 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.88[0.16; 50.50]1515 -NAThe NAAED (Indications NOS) (Controls unexposed, disease free), 2024 1 exposed to other treatment, sickexposed to other treatment, sick 10.48[0.42; 258.67]1102 -NABattino (Epilepsy), 2024 1 Tags Adjustment   - No  - No 5.11[0.60; 43.25]125170%NABattino (Epilepsy), 2024 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 2 All studiesAll studies 5.11[0.60; 43.25]125170%NABattino (Epilepsy), 2024 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 20.550.01.0

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 17166

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.88[0.16; 50.50]1515 -NAThe NAAED (Indications NOS) (Controls unexposed, disease free), 2024 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 3.62[0.43; 30.27]162170%NABattino (Epilepsy), 2024 The NAAED (Indications NOS) (Controls exposed to LTG), 2024 20.510.01.0