Lamotrigine (All indications)

Cleft palate

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.
S10035
R36160		 Blotière (Lamotrigine) (Mixed indications), 2019 Cleft palate 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.10 [0.10;3.90] 2/2,997   1,178/1,875,733 1,180 2,997
ref
S8971
R30404		 Dolk (Lamotrigine) (Mixed indications), 2016 Isolated cleft palate 1st trimester case control unexposed (general population or NOS) Adjustment: Yes 1.23 [0.39;3.89] -/-   0/ - -
ref
S8921
R30149		 Holmes (Lamotrigine), 2008 Cleft palate alone isolated 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No 21.00 [6.80;65.10] 3/684   43/206,224 46 684
ref
Total 3 studies 3.22 [0.42;25.01] 1,226 3,681
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 Blotière (Lamotrigine) (Mixed indications), 2019Blotière, 2019 1 1.10[0.10; 3.90]1,1802,99730%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Dolk (Lamotrigine) (Mixed indications), 2016Dolk, 2016 2 1.23[0.39; 3.89]--35%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Holmes (Lamotrigine), 2008Holmes, 2008 3 21.00[6.80; 65.10]4668435%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Total (3 studies) I2 = 86% 3.22[0.42; 25.01]1,2263,6810.550.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Lamotrigine) (Mixed indications; 2: Lamotrigine) (Mixed indications; 3: Lamotrigine;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 5.27[0.29; 94.28]1,2263,68186%NABlotière (Lamotrigine) (Mixed indications), 2019 Holmes (Lamotrigine), 2008 2 case control studiescase control studies 1.23[0.39; 3.88]-- -NADolk (Lamotrigine) (Mixed indications), 2016 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 3.22[0.42; 25.01]1,2263,68186%NABlotière (Lamotrigine) (Mixed indications), 2019 Dolk (Lamotrigine) (Mixed indications), 2016 Holmes (Lamotrigine), 2008 3 Tags Adjustment   - No  - No 5.27[0.29; 94.28]1,2263,68186%NABlotière (Lamotrigine) (Mixed indications), 2019 Holmes (Lamotrigine), 2008 2   - Yes  - Yes 1.23[0.39; 3.88]-- -NADolk (Lamotrigine) (Mixed indications), 2016 1 All studiesAll studies 3.22[0.42; 25.01]1,2263,68186%NABlotière (Lamotrigine) (Mixed indications), 2019 Dolk (Lamotrigine) (Mixed indications), 2016 Holmes (Lamotrigine), 2008 30.550.01.0

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

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 3.22[0.42; 25.01]1,2263,68186%NABlotière (Lamotrigine) (Mixed indications), 2019 Dolk (Lamotrigine) (Mixed indications), 2016 Holmes (Lamotrigine), 2008 30.510.01.0