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

All congenital malformations (majors, minors, majors and minors, or unspecified)

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.
S17209
R72097
The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls exposed to LTG), 2024 Major congenital malformations at least 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 3.76 [0.17;80.92] C
excluded (control group)
0/3   20/406 20 3
ref
S17210
R72099
The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024 Major congenital malformations at least 1st trimester prospective cohort unexposed, sick Adjustment: No 5.32 [0.23;120.81] C 0/3   7/207 7 3
ref
S17196
R72071
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024 Major congenital malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 10.78 [0.30;390.33] C
excluded (control group)
0/2   1/50 1 2
ref
S17197
R72073
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 Major congenital malformations 1st trimester prospective cohort unexposed, sick Adjustment: No 6.54 [0.26;166.65] C 0/2   16/340 16 2
ref
S17178
R72008
The NAAED (Indications NOS) (Controls exposed to LTG), 2024 Major congenital malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 5.10 [0.27;95.90] C
excluded (control group)
0/5   52/2,461 52 5
ref
S17179
R72010
The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 Major congenital malformations 1st trimester prospective cohort unexposed, disease free Adjustment: No 9.29 [0.48;180.01] C 0/5   15/1,311 15 5
ref
S17221
R72121
The West China Registry (Epilepsy) (Controls exposed to LTG), 2024 Major congenital malformation during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No 15.00 [0.24;926.88] C
excluded (control group)
0/3   0/38 0 3
ref
S17222
R72123
The West China Registry (Epilepsy) (Controls unexposed, sick), 2024 Major congenital malformation during pregnancy (anytime or not specified) excluded prospective cohort unexposed, sick Adjustment: No 6.55 [0.29;148.57] C
excluded (exposition period)
0/3   7/253 7 3
ref
Total 3 studies 6.94 [1.16;41.64] 38 10
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 Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024The Australian Pregnancy Regi..., 2024 1 5.32[0.23; 120.81]7333%ROB confusion: criticalROB selection: unclearROB classification: unclearROB missing: unclearROB mesure: criticalROB reporting: moderate The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024The Kerala Registry for Epile..., 2024 2 6.54[0.26; 166.65]16231%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate The NAAED (Indications NOS) (Controls unexposed, disease free), 2024The NAAED, 2024 3 9.29[0.48; 180.01]15537%ROB confusion: criticalROB selection: unclearROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: low Total (3 studies) I2 = 0% 6.94[1.16; 41.64]38100.920.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Mixed indications) (Controls unexposed, sick; 2: Epilepsy) (Controls unexposed, sick; 3: Indications NOS) (Controls unexposed, disease free;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 6.94[1.16; 41.64]38100%NAThe Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 9.29[0.48; 180.01]155 -NAThe NAAED (Indications NOS) (Controls unexposed, disease free), 2024 1 unexposed, sickunexposed, sick 5.87[0.62; 55.62]2350%NAThe Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 2 Tags Adjustment   - No  - No 6.94[1.16; 41.64]38100%NAThe Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 3 All studiesAll studies 6.94[1.16; 41.64]38100%NAThe Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 30.520.01.0

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 17209, 17196, 17178, 17221

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 9.29[0.48; 180.01]155 -NAThe NAAED (Indications NOS) (Controls unexposed, disease free), 2024 1 unexposed, sick controlsunexposed, sick controls 5.87[0.62; 55.62]2350%NAThe Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 5.56[0.89; 34.49]73100%NAThe Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls exposed to LTG), 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024 The NAAED (Indications NOS) (Controls exposed to LTG), 2024 30.510.01.0