Levetiracetam (All indications)

Low birth weight (< 2500g)

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.
S10071
R36652		 Coste (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020 Weight at birth <2500 g during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 1.65 [1.20;2.28] C
excluded (control group) 		60/621   128/2,108 188 621
ref
S9020
R30709		 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Weight at birth <2500 g during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.89 [1.45;2.47] C 60/621   91,455/1,710,441 91,515 621
ref
S9030
R30786		 Kilic (Levetiracetam) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Low birth weight (< 2500 g) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 1.44 [0.33;6.26] C
excluded (control group) 		2/26   48/876 50 26
ref
S9031
R30789		 Kilic (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2014 Low birth weight (< 2500 g) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: No 2.31 [0.54;9.76] C
excluded (control group) 		2/26   23,503/673,844 23,505 26
ref
S9032
R30792		 Kilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 Low birth weight (< 2500 g) during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: No Controls: epilepsy indication 1.68 [0.40;7.16] C 2/26   249/5,275 251 26
ref
S8983
R30483		 Artama (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2013 Low birth weight (< 2500g) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 5.06 [0.91;28.06] C
excluded (control group) 		2/13   6/173 8 13
ref
S8984
R30495		 Artama (Levetiracetam) (Controls unexposed, disease free), 2013 Low birth weight (< 2500g) during pregnancy (anytime or not specified) population based cohort retrospective unexposed, disease free excluded Adjustment: Yes 4.74 [1.01;22.18]
excluded (control group) 		2/13   21,546/719,509 21,548 13
ref
S8985
R30507		 Artama (Levetiracetam) (Controls unexposed, sick), 2013 Low birth weight (< 2500g) during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: Yes 4.57 [0.87;24.10] 2/13   65/1,793 67 13
ref
Total 3 studies 1.93 [1.49;2.50] 91,833 660
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 Coste (Levetiracetam) (Controls unexposed, NOS), 2020Coste, 2020 1 1.89[1.45; 2.47]91,51562194%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Kilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014Kilic, 2014 2 1.68[0.40; 7.16]251263%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Artama (Levetiracetam) (Controls unexposed, sick), 2013Artama, 2013 3 4.57[0.87; 24.10]67132%ROB confusion: moderateROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Total (3 studies) I2 = 0% 1.93[1.49; 2.50]91,8336600.510.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Levetiracetam) (Controls unexposed, NOS; 2: Levetiracetam) (Controls unexposed, sick) (Mixed indications; 3: Levetiracetam) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.93[1.49; 2.50]91,8336600%NACoste (Levetiracetam) (Controls unexposed, NOS), 2020 Kilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 Artama (Levetiracetam) (Controls unexposed, sick), 2013 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.89[1.45; 2.47]91,515621 -NACoste (Levetiracetam) (Controls unexposed, NOS), 2020 1 unexposed, sickunexposed, sick 2.59[0.87; 7.72]318390%NAKilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 Artama (Levetiracetam) (Controls unexposed, sick), 2013 2 Tags Adjustment   - No  - No 1.89[1.45; 2.45]91,7666470%NACoste (Levetiracetam) (Controls unexposed, NOS), 2020 Kilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 2   - Yes  - Yes 4.57[0.87; 24.05]6713 -NAArtama (Levetiracetam) (Controls unexposed, sick), 2013 1 Controls   - epilepsy indication  - epilepsy indication 1.68[0.40; 7.16]25126 -NAKilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 1 All studiesAll studies 1.93[1.49; 2.50]91,8336600%NACoste (Levetiracetam) (Controls unexposed, NOS), 2020 Kilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 Artama (Levetiracetam) (Controls unexposed, sick), 2013 30.510.01.0

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 8983, 8984, 9030, 9031, 10071

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.95[1.51; 2.53]136,5686600%NACoste (Levetiracetam) (Controls unexposed, NOS), 2020 Kilic (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2014 Artama (Levetiracetam) (Controls unexposed, disease free), 2013 3 unexposed, sick controlsunexposed, sick controls 2.59[0.87; 7.72]318390%NAKilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 Artama (Levetiracetam) (Controls unexposed, sick), 2013 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.70[1.25; 2.32]2466600%NACoste (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020 Kilic (Levetiracetam) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Artama (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2013 30.510.01.0