Zonisamide (Epilepsy)

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.
S7506
R22455		 Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2020 Major congenital malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 1.75 [0.19;16.25] C
excluded (control group) 		1/13   5/110 6 13
ref
S7497
R22428		 Meador (Zonisamide) (Controls unexposed, disease free), 2020 Major congenital malformations 1st trimester prospective cohort unexposed, disease free excluded Adjustment: No 4.33 [0.37;51.42] C
excluded (control group) 		1/13   2/106 3 13
ref
S7502
R22443		 Meador (Zonisamide) (Controls unexposed, sick), 2020 Major congenital malformations 1st trimester prospective cohort unexposed, sick Adjustment: No 1.17 [0.07;20.72] C 1/13   1/15 2 13
ref
S7669
R22699		 Tomson (Zonisamide), 2018 Malformed Offspring at least 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 1.93 [0.11;33.69] C 0/9   74/2,514 74 9
ref
S8122
R24945		 Hernández-Díaz (Zonisamide) (Controls exposed to Lamotrigine, sick), 2012 Major congenital malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No Controls: mixed indications 0.27 [0.02;4.47] C
excluded (control group) 		0/90   31/1,562 31 90
ref
S7939
R24015		 Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012 Major congenital malformations 1st trimester prospective cohort unexposed, disease free Adjustment: No 0.44 [0.02;8.09] C 0/90   5/442 5 90
ref
Total 3 studies 1.01 [0.19;5.31] 81 112
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 Meador (Zonisamide) (Controls unexposed, sick), 2020Meador, 2020 1 1.17[0.07; 20.72]21333%ROB confusion: unclearROB selection: lowROB classification: lowROB missing: lowROB mesure: moderateROB reporting: low Tomson (Zonisamide), 2018Tomson, 2018 2 1.93[0.11; 33.69]74934%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012Hernández-Díaz, 2012 3 0.44[0.02; 8.09]59033%ROB confusion: moderateROB selection: lowROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Total (3 studies) I2 = 0% 1.01[0.19; 5.31]811120.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Zonisamide) (Controls unexposed, sick; 2: Zonisamide; 3: Zonisamide) (Controls unexposed, disease free;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.01[0.19; 5.31]811120%NAMeador (Zonisamide) (Controls unexposed, sick), 2020 Tomson (Zonisamide), 2018 Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.44[0.02; 8.09]590 -NAHernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012 1 unexposed, sickunexposed, sick 1.17[0.07; 20.72]213 -NAMeador (Zonisamide) (Controls unexposed, sick), 2020 1 exposed to other treatment, sickexposed to other treatment, sick 1.93[0.11; 33.69]749 -NATomson (Zonisamide), 2018 1 Tags Adjustment   - No  - No 1.01[0.19; 5.31]811120%NAMeador (Zonisamide) (Controls unexposed, sick), 2020 Tomson (Zonisamide), 2018 Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012 3 All studiesAll studies 1.01[0.19; 5.31]811120%NAMeador (Zonisamide) (Controls unexposed, sick), 2020 Tomson (Zonisamide), 2018 Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012 30.25.01.0

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 8122, 7506, 7497

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.58[0.17; 14.55]810327%NAMeador (Zonisamide) (Controls unexposed, disease free), 2020 Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012 2 unexposed, sick controlsunexposed, sick controls 1.17[0.07; 20.72]213 -NAMeador (Zonisamide) (Controls unexposed, sick), 2020 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.06[0.24; 4.70]1111120%NAMeador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2020 Tomson (Zonisamide), 2018 Hernández-Díaz (Zonisamide) (Controls exposed to Lamotrigine, sick), 2012 30.510.01.0