Carbamazepine (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.
S9777
R34988		 Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 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 0.78 [0.11;5.54] C 1/468   4,695/1,710,441 4,696 468
ref
S9598
R34002		 Artama (Carbamazepine) (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 0.96 [0.12;8.05] C
excluded (control group) 		6/1,077   1/173 7 1,077
ref
S9599
R34014		 Artama (Carbamazepine) (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 1.94 [0.86;4.39]
excluded (control group) 		6/1,077   2,048/719,509 2,054 1,077
ref
S9600
R34026		 Artama (Carbamazepine) (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 2.70 [0.72;10.07] 6/1,077   5/1,793 11 1,077
ref
S9740
R34700		 Van der Pol (Carbamazepine) (Controls unexposed, disease free), 1991 Death (from 6 to 13 years) throughout pregnancy prospective cohort unexposed, disease free excluded Adjustment: No Matched 5.26 [0.10;278.85] C
excluded (control group) 		0/12   0/61 0 12
ref
S9741
R34725		 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 Death (from 6 to 13 years) throughout pregnancy prospective cohort unexposed, sick Adjustment: No 0.65 [0.02;17.31] C 0/12   1/24 1 12
ref
Total 3 studies 1.65 [0.59;4.67] 4,708 1,557
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 (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020Coste, 2020 1 0.78[0.11; 5.54]4,69646828%ROB confusion: moderateROB selection: moderateROB classification: criticalROB missing: moderateROB mesure: criticalROB reporting: moderate Artama (Carbamazepine) (Controls unexposed, sick), 2013Artama, 2013 2 2.70[0.72; 10.07]111,07762%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991Van der Pol, 1991 3 0.65[0.02; 17.31]11210%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Total (3 studies) I2 = 0% 1.65[0.59; 4.67]4,7081,5570.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

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

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.65[0.59; 4.67]4,7081,5570%NACoste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.78[0.11; 5.54]4,696468 -NACoste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 1 unexposed, sickunexposed, sick 2.22[0.65; 7.53]121,0890%NAArtama (Carbamazepine) (Controls unexposed, sick), 2013 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 2 Tags Adjustment   - No  - No 0.74[0.14; 4.00]4,6974800%NACoste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 2   - Yes  - Yes 2.70[0.72; 10.10]111,077 -NAArtama (Carbamazepine) (Controls unexposed, sick), 2013 1 All studiesAll studies 1.65[0.59; 4.67]4,7081,5570%NACoste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Artama (Carbamazepine) (Controls unexposed, sick), 2013 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 30.210.01.0

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 9740, 9598, 9599

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.76[0.84; 3.70]6,7501,5570%NACoste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 Artama (Carbamazepine) (Controls unexposed, disease free), 2013 Van der Pol (Carbamazepine) (Controls unexposed, disease free), 1991 3 unexposed, sick controlsunexposed, sick controls 2.22[0.65; 7.53]121,0890%NAArtama (Carbamazepine) (Controls unexposed, sick), 2013 Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.96[0.12; 8.05]71,077 -NAArtama (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2013 10.510.01.0