Valproate (All indications)

Child/Infant death (> 28 days of life)

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.
S9392
R32904		 Coste (Valproate) (Controls unexposed, NOS), 2020 Death (Mean follow up 3-4 years) during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 2.96 [1.47;5.93] C 8/991   4,695/1,710,441 4,703 991
ref
S9283
R32213		 Artama (Valproate) (Controls exposed to Lamotrigine, sick), 2013 Infant death (0–364 days of age) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 1.48 [0.18;12.38] C
excluded (control group) 		6/703   1/173 7 703
ref
S9284
R32225		 Artama (Valproate) (Controls unexposed, disease free), 2013 Infant death (0–364 days of age) during pregnancy (anytime or not specified) population based cohort retrospective unexposed, disease free excluded Adjustment: Yes 1.76 [0.77;4.01]
excluded (control group) 		6/703   2,048/719,509 2,054 703
ref
S9285
R32237		 Artama (Valproate) (Controls unexposed, sick), 2013 Infant death (0–364 days of age) during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: Yes 3.23 [0.83;12.56] 6/703   5/1,793 11 703
ref
Total 2 studies 3.01 [1.62;5.60] 4,714 1,694
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 (Valproate) (Controls unexposed, NOS), 2020Coste, 2020 1 2.96[1.47; 5.93]4,70399179%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Artama (Valproate) (Controls unexposed, sick), 2013Artama, 2013 2 3.23[0.83; 12.56]1170321%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Total (2 studies) I2 = 0% 3.01[1.62; 5.60]4,7141,6940.910.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Valproate) (Controls unexposed, NOS; 2: Valproate) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 3.01[1.62; 5.60]4,7141,6940%NACoste (Valproate) (Controls unexposed, NOS), 2020 Artama (Valproate) (Controls unexposed, sick), 2013 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.96[1.47; 5.93]4,703991 -NACoste (Valproate) (Controls unexposed, NOS), 2020 1 unexposed, sickunexposed, sick 3.23[0.83; 12.56]11703 -NAArtama (Valproate) (Controls unexposed, sick), 2013 1 Tags Adjustment   - No  - No 2.96[1.47; 5.93]4,703991 -NACoste (Valproate) (Controls unexposed, NOS), 2020 1   - Yes  - Yes 3.23[0.83; 12.56]11703 -NAArtama (Valproate) (Controls unexposed, sick), 2013 1 All studiesAll studies 3.01[1.62; 5.60]4,7141,6940%NACoste (Valproate) (Controls unexposed, NOS), 2020 Artama (Valproate) (Controls unexposed, sick), 2013 20.510.01.0

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 9283, 9284

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.38[1.40; 4.06]6,7571,6940%NACoste (Valproate) (Controls unexposed, NOS), 2020 Artama (Valproate) (Controls unexposed, disease free), 2013 2 unexposed, sick controlsunexposed, sick controls 3.23[0.83; 12.56]11703 -NAArtama (Valproate) (Controls unexposed, sick), 2013 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.48[0.18; 12.38]7703 -NAArtama (Valproate) (Controls exposed to Lamotrigine, sick), 2013 10.510.01.0