Pregabalin (Epilepsy)

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.
S7796
R35163		 Vajda (Pregabalin) (Controls exposed to Lamotrigine, sick), 2019 Fetal malformations at least 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 18.80 [0.36;971.86] C
excluded (control group) 		0/1   20/406 20 1
ref
S7797
R35164		 Vajda (Pregabalin) (Controls unexposed, sick), 2019 Fetal malformations at least 1st trimester prospective cohort unexposed, sick Adjustment: No 31.00 [0.56;1711.11] C 0/1   5/176 5 1
ref
S7665
R26772		 Tomson (Pregabalin), 2018 Malformed Offspring at least 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 4.68 [0.24;91.38] C 0/4   74/2,514 74 4
ref
Total 2 studies 9.14 [0.84;99.60] 79 5
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 Vajda (Pregabalin) (Controls unexposed, sick), 2019Vajda, 2019 1 31.00[0.56; 1711.11]5135%ROB confusion: criticalROB selection: moderateROB classification: lowROB missing: moderateROB mesure: moderateROB reporting: moderate Tomson (Pregabalin), 2018Tomson, 2018 2 4.68[0.24; 91.38]74465%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (2 studies) I2 = 0% 9.14[0.84; 99.60]7950.9100.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Pregabalin) (Controls unexposed, sick; 2: Pregabalin;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 9.14[0.84; 99.60]7950%NAVajda (Pregabalin) (Controls unexposed, sick), 2019 Tomson (Pregabalin), 2018 2 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 31.00[0.56; 1711.11]51 -NAVajda (Pregabalin) (Controls unexposed, sick), 2019 1 exposed to other treatment, sickexposed to other treatment, sick 4.68[0.24; 91.38]744 -NATomson (Pregabalin), 2018 1 Tags Adjustment   - No  - No 9.14[0.84; 99.60]7950%NAVajda (Pregabalin) (Controls unexposed, sick), 2019 Tomson (Pregabalin), 2018 2 All studiesAll studies 9.14[0.84; 99.60]7950%NAVajda (Pregabalin) (Controls unexposed, sick), 2019 Tomson (Pregabalin), 2018 20.5100.01.0

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 7796

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed, sick controlsunexposed, sick controls Out of scale31.00[0.56; 1711.11]51 -NAVajda (Pregabalin) (Controls unexposed, sick), 2019 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 7.74[0.72; 83.14]9450%NAVajda (Pregabalin) (Controls exposed to Lamotrigine, sick), 2019 Tomson (Pregabalin), 2018 20.510.01.0